Trial Outcomes & Findings for TAP Block for Postoperative Pain Control (NCT NCT02652156)
NCT ID: NCT02652156
Last Updated: 2018-11-02
Results Overview
The total use of analgesic medications will be recorded during the 3 days immediately following surgery.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
14 participants
Primary outcome timeframe
3 postoperative days
Results posted on
2018-11-02
Participant Flow
Participant milestones
| Measure |
Single Injection of Bupivacaine
Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
|
Single Injection of Exparel®
Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
|
Continuous Infusion of Ropivacaine
Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
4
|
|
Overall Study
COMPLETED
|
3
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Single Injection of Bupivacaine
Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
|
Single Injection of Exparel®
Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
|
Continuous Infusion of Ropivacaine
Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
Baseline Characteristics
TAP Block for Postoperative Pain Control
Baseline characteristics by cohort
| Measure |
Single Injection of Bupivacaine
n=4 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
|
Single Injection of Exparel®
n=6 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
|
Continuous Infusion of Ropivacaine
n=4 Participants
Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
4 participants
n=206 Participants
|
14 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 3 postoperative daysPopulation: 1 patient in the Continuous Infusion of Ropivacaine group required no narcotics immediately following surgery (recovery room) due to continuing effect of the blockade. Patients are removed from study upon discharge in later postoperative days.
The total use of analgesic medications will be recorded during the 3 days immediately following surgery.
Outcome measures
| Measure |
Single Injection of Bupivacaine
n=3 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
|
Single Injection of Exparel®
n=6 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
|
Continuous Infusion of Ropivacaine
n=4 Participants
Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
|
|---|---|---|---|
|
Total Dosage of Narcotic
Narcotic Use - Day of Surgery - Recovery room
|
23.2 Mophine Equivalent Units
Standard Deviation 19.1
|
14.4 Mophine Equivalent Units
Standard Deviation 11.8
|
35.7 Mophine Equivalent Units
Standard Deviation 22.6
|
|
Total Dosage of Narcotic
Narcotic Use - Postoperative Day 0
|
33.0 Mophine Equivalent Units
Standard Deviation 34.0
|
42.2 Mophine Equivalent Units
Standard Deviation 39.9
|
45.0 Mophine Equivalent Units
Standard Deviation 23.9
|
|
Total Dosage of Narcotic
Narcotic Use - Postoperative Day 1
|
87.7 Mophine Equivalent Units
Standard Deviation 106.5
|
139.0 Mophine Equivalent Units
Standard Deviation 194.6
|
47.9 Mophine Equivalent Units
Standard Deviation 36.4
|
|
Total Dosage of Narcotic
Narcotic Use - Postoperative Day 2
|
127.0 Mophine Equivalent Units
Standard Deviation 61.0
|
103.3 Mophine Equivalent Units
Standard Deviation 112.7
|
44.7 Mophine Equivalent Units
Standard Deviation 36.4
|
|
Total Dosage of Narcotic
Narcotic Use - Postoperative Day 3
|
318.0 Mophine Equivalent Units
Standard Deviation 0
|
41.6 Mophine Equivalent Units
Standard Deviation 40.6
|
68.0 Mophine Equivalent Units
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 3 postoperative daysPopulation: No vomiting events were reported by any study subjects.
Total number of vomiting episodes over the three postoperative days.
Outcome measures
| Measure |
Single Injection of Bupivacaine
n=3 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
|
Single Injection of Exparel®
n=6 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
|
Continuous Infusion of Ropivacaine
n=4 Participants
Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
|
|---|---|---|---|
|
Postoperative Vomiting (Events)
|
0 Vomiting Events
|
0 Vomiting Events
|
0 Vomiting Events
|
SECONDARY outcome
Timeframe: Postoperative Day 1Patients will rate their pain by VAS scale 1 day post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
Outcome measures
| Measure |
Single Injection of Bupivacaine
n=3 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
|
Single Injection of Exparel®
n=6 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
|
Continuous Infusion of Ropivacaine
n=4 Participants
Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
|
|---|---|---|---|
|
Patient Reported Pain by VAS Scale
|
4.4 score on a scale
Standard Deviation 0.4
|
3.8 score on a scale
Standard Deviation 0.9
|
4.5 score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Postoperative Day 2Patients will rate their pain by VAS scale 2 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
Outcome measures
| Measure |
Single Injection of Bupivacaine
n=3 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
|
Single Injection of Exparel®
n=6 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
|
Continuous Infusion of Ropivacaine
n=4 Participants
Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
|
|---|---|---|---|
|
Patient Reported Pain by VAS Scale
|
4.2 score on a scale
Standard Deviation 1.6
|
2.0 score on a scale
Standard Deviation 1.2
|
5.3 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Postoperative Day 3Population: Two patients in each of the Single Injection of Bupivacaine and Continuous Infusion of Ropivacaine groups were discharged prior to post-operative day 3. Pain rating data for these subjects were not collected.
Patients will rate their pain by VAS scale 3 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
Outcome measures
| Measure |
Single Injection of Bupivacaine
n=1 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
|
Single Injection of Exparel®
n=6 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
|
Continuous Infusion of Ropivacaine
n=2 Participants
Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
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|---|---|---|---|
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Patient Reported Pain by VAS Scale
|
4.0 score on a scale
Standard Deviation 0
|
2.2 score on a scale
Standard Deviation 1.2
|
3.8 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Assessed daily for up to 3 days post-surgeryPopulation: All 3 patients in the Single Injection of Bupivacaine cohort required 1 day to be able to get out of bed.
Patients will be assessed each day following the day of surgery for the ability to get out of bed.
Outcome measures
| Measure |
Single Injection of Bupivacaine
n=3 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
|
Single Injection of Exparel®
n=6 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
|
Continuous Infusion of Ropivacaine
n=4 Participants
Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
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|---|---|---|---|
|
Number of Days Required for a Patient to Get Out of Bed
|
1.0 days
Standard Deviation 0.0
|
0.8 days
Standard Deviation 0.4
|
0.3 days
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Assessed daily for up to 3 days post-surgeryPatients will be assessed each day following the day of surgery for the ability to walk unassisted
Outcome measures
| Measure |
Single Injection of Bupivacaine
n=3 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
|
Single Injection of Exparel®
n=6 Participants
Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
|
Continuous Infusion of Ropivacaine
n=4 Participants
Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
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|---|---|---|---|
|
Number of Days Required for a Patient to Walk Unassisted
|
1.3 days
Standard Deviation 0.5
|
1.5 days
Standard Deviation 0.5
|
1.3 days
Standard Deviation 0.5
|
Adverse Events
Single Injection of Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single Injection of Exparel®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Continuous Infusion of Ropivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Trials
Midwestern Regional Medical Center
Phone: 847-731-1648
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place