Trial Outcomes & Findings for Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery (NCT NCT02356198)
NCT ID: NCT02356198
Last Updated: 2019-03-07
Results Overview
Postoperative mean pain score for 48 hours after surgery. Pain was assessed on a 0 to 10 point visual analog scale (VAS), with 0 indicating no pain and 10 indicating severe pain. The mean pain score was summarized as the area under the curve (AUC) of the observed pain score, normalized for the total time of observation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
209 participants
Primary outcome timeframe
First 48 hours post operative
Results posted on
2019-03-07
Participant Flow
Participant milestones
| Measure |
TAP Block (EXPAREL)
After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.
EXPAREL: transversus abdominis plane injection
|
Intrathecal Opioid (IT)
single injection intrathecal hydromorphone analgesia given preoperatively
Intrathecal hydromorphone: Intrathecal opioid administration
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
105
|
|
Overall Study
COMPLETED
|
102
|
98
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TAP Block (EXPAREL)
n=102 Participants
After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.
EXPAREL: transversus abdominis plane injection
|
Intrathecal Opioid (IT)
n=98 Participants
single injection intrathecal hydromorphone analgesia given preoperatively
Intrathecal hydromorphone: Intrathecal opioid administration
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=102 Participants
|
58 years
n=98 Participants
|
60 years
n=200 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=102 Participants
|
43 Participants
n=98 Participants
|
88 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=102 Participants
|
55 Participants
n=98 Participants
|
112 Participants
n=200 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
102 participants
n=102 Participants
|
98 participants
n=98 Participants
|
200 participants
n=200 Participants
|
PRIMARY outcome
Timeframe: First 48 hours post operativePostoperative mean pain score for 48 hours after surgery. Pain was assessed on a 0 to 10 point visual analog scale (VAS), with 0 indicating no pain and 10 indicating severe pain. The mean pain score was summarized as the area under the curve (AUC) of the observed pain score, normalized for the total time of observation.
Outcome measures
| Measure |
TAP Block (EXPAREL)
n=102 Participants
After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.
EXPAREL: transversus abdominis plane injection
|
Intrathecal Opioid (IT)
n=98 Participants
single injection intrathecal hydromorphone analgesia given preoperatively
Intrathecal hydromorphone: Intrathecal opioid administration
|
|---|---|---|
|
Mean Pain Score
|
3.0 score on a scale
Interval 2.7 to 3.3
|
2.4 score on a scale
Interval 2.1 to 2.7
|
PRIMARY outcome
Timeframe: First 48 hours post operativeThe total cumulative use of opioids administered within 48 hours after surgery. MME is a standard value based on morphine and its potency assigned to all opioids to represent relative potencies.
Outcome measures
| Measure |
TAP Block (EXPAREL)
n=102 Participants
After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.
EXPAREL: transversus abdominis plane injection
|
Intrathecal Opioid (IT)
n=98 Participants
single injection intrathecal hydromorphone analgesia given preoperatively
Intrathecal hydromorphone: Intrathecal opioid administration
|
|---|---|---|
|
Total Morphine Milligram Equivalents Use (MME)
|
47.5 total morphine milligram equivalents
Interval 35.6 to 65.9
|
32.5 total morphine milligram equivalents
Interval 24.4 to 42.0
|
SECONDARY outcome
Timeframe: post-operative to dischargeLength of stay was defined as the total number of nights spent in the hospital after surgery.
Outcome measures
| Measure |
TAP Block (EXPAREL)
n=102 Participants
After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.
EXPAREL: transversus abdominis plane injection
|
Intrathecal Opioid (IT)
n=98 Participants
single injection intrathecal hydromorphone analgesia given preoperatively
Intrathecal hydromorphone: Intrathecal opioid administration
|
|---|---|---|
|
Total Length of Hospital Stay
|
3 nights
Interval 3.0 to 3.0
|
3 nights
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: 24 hours post-operativelyPost-operative ileus was defined as the inability to tolerate oral diet and/or the absence of flatus over 24 hours after surgery.
Outcome measures
| Measure |
TAP Block (EXPAREL)
n=102 Participants
After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.
EXPAREL: transversus abdominis plane injection
|
Intrathecal Opioid (IT)
n=98 Participants
single injection intrathecal hydromorphone analgesia given preoperatively
Intrathecal hydromorphone: Intrathecal opioid administration
|
|---|---|---|
|
Number of Participants With Post-operative Ileus
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: First 48 hours post-operativeThe total number of patients that used patient-controlled analgesia within 48 hours after surgery.
Outcome measures
| Measure |
TAP Block (EXPAREL)
n=102 Participants
After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.
EXPAREL: transversus abdominis plane injection
|
Intrathecal Opioid (IT)
n=98 Participants
single injection intrathecal hydromorphone analgesia given preoperatively
Intrathecal hydromorphone: Intrathecal opioid administration
|
|---|---|---|
|
Use of Intravenous Patient-controlled Analgesia
|
5 Participants
|
1 Participants
|
Adverse Events
TAP Block (EXPAREL)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Intrathecal Opioid (IT)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAP Block (EXPAREL)
n=102 participants at risk
After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.
EXPAREL: transversus abdominis plane injection
|
Intrathecal Opioid (IT)
n=98 participants at risk
single injection intrathecal hydromorphone analgesia given preoperatively
Intrathecal hydromorphone: Intrathecal opioid administration
|
|---|---|---|
|
Infections and infestations
Peristomal wound infection
|
0.00%
0/102 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
1.0%
1/98 • Number of events 1 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/102 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
1.0%
1/98 • Number of events 1 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
|
Nervous system disorders
Spinal fluid leakage
|
0.00%
0/102 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
1.0%
1/98 • Number of events 1 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
|
Blood and lymphatic system disorders
Bleeding at injection site
|
0.00%
0/102 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
1.0%
1/98 • Number of events 1 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.98%
1/102 • Number of events 1 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
0.00%
0/98 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
|
Gastrointestinal disorders
Intra-abdominal abscess
|
0.98%
1/102 • Number of events 1 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
0.00%
0/98 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
|
Gastrointestinal disorders
Anastomosis leakage
|
0.98%
1/102 • Number of events 1 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
0.00%
0/98 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea with hypoxia
|
0.98%
1/102 • Number of events 1 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
0.00%
0/98 • The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place