Trial Outcomes & Findings for ESP Block VS Intrathecal Opioid After Laparoscopic Colorectal Surgery (NCT NCT05257941)
NCT ID: NCT05257941
Last Updated: 2026-03-02
Results Overview
24 hour cumulated oral morphine consumption (OME)
TERMINATED
PHASE1/PHASE2
116 participants
24 hours after surgery
2026-03-02
Participant Flow
Participant milestones
| Measure |
IT Injection
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
|
Overall Study
COMPLETED
|
56
|
51
|
|
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 |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=56 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=107 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=56 Participants
|
34 Participants
n=51 Participants
|
70 Participants
n=107 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=56 Participants
|
17 Participants
n=51 Participants
|
37 Participants
n=107 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 15 • n=56 Participants
|
62 years
STANDARD_DEVIATION 13 • n=51 Participants
|
61 years
STANDARD_DEVIATION 15 • n=107 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=56 Participants
|
27 Participants
n=51 Participants
|
61 Participants
n=107 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=56 Participants
|
24 Participants
n=51 Participants
|
46 Participants
n=107 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
56 participants
n=56 Participants
|
51 participants
n=51 Participants
|
107 participants
n=107 Participants
|
|
weight
|
78 kg
STANDARD_DEVIATION 17 • n=56 Participants
|
81 kg
STANDARD_DEVIATION 19 • n=51 Participants
|
80 kg
STANDARD_DEVIATION 18 • n=107 Participants
|
PRIMARY outcome
Timeframe: 24 hours after surgeryPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
24 hour cumulated oral morphine consumption (OME)
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
24 Hour Cumulated Oral Morphine Equivalent (OME)
|
44.49 mg morphine equivalents
Standard Deviation 55.39
|
45.17 mg morphine equivalents
Standard Deviation 34.67
|
SECONDARY outcome
Timeframe: 1 hour after surgeryPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
Oral Morphine Equivalents consumed
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Oral Morphine Equivalents (OME)
|
12.2232 mg morphine equivalents
Standard Error 3.7958
|
11.9706 mg morphine equivalents
Standard Error 3.9775
|
SECONDARY outcome
Timeframe: 12 hours after surgeryPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
Oral Morphine Equivalent consumption
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Oral Morphine Equivalents (OME)
|
17.1964 mg morphine equivalents
Standard Error 3.7958
|
20.7255 mg morphine equivalents
Standard Error 3.9775
|
SECONDARY outcome
Timeframe: 24 hours after surgeryPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
Oral Morphine Equivalent consumption
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Oral Morphine Equivalents (OME)
|
15.0714 mg morphine equivalents
Standard Error 3.7958
|
12.4706 mg morphine equivalents
Standard Error 3.9775
|
SECONDARY outcome
Timeframe: 48 hours after surgeryPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
Oral Morphine Equivalent consumption
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Oral Morphine Equivalents (OME)
|
38.7946 mg morphine equivalents
Standard Error 3.7958
|
21.6275 mg morphine equivalents
Standard Error 3.9775
|
SECONDARY outcome
Timeframe: 72 hours after surgeryPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
Oral Morphine Equivalent Consumption
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Oral Morphine Equivalents (OME)
|
30.8304 mg morphine equivalents
Standard Error 3.7958
|
14.8627 mg morphine equivalents
Standard Error 3.9775
|
SECONDARY outcome
Timeframe: 1 hour after surgeryPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Visual Analog Scale Pain Scores
|
3.4107 score on a scale
Standard Error 0.3586
|
4.4118 score on a scale
Standard Error 0.3758
|
SECONDARY outcome
Timeframe: 12 hours after surgeryPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Visual Analog Scale Pain Scores
|
2.8214 score on a scale
Standard Error 0.3586
|
3.8431 score on a scale
Standard Error 0.3758
|
SECONDARY outcome
Timeframe: 24 hours after surgeryPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Visual Analog Scale Pain Scores
|
3.7857 score on a scale
Standard Error 0.3586
|
4.1176 score on a scale
Standard Error 0.3758
|
SECONDARY outcome
Timeframe: 48 hours after surgeryPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Visual Analog Scale Pain Scores
|
4.2500 score on a scale
Standard Error 0.3586
|
3.5098 score on a scale
Standard Error 0.3758
|
SECONDARY outcome
Timeframe: 72 hours after surgeryPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Visual Analog Scale Pain Scores
|
3.4643 score on a scale
Standard Error 0.3586
|
2.9020 score on a scale
Standard Error 0.3758
|
SECONDARY outcome
Timeframe: Duration of hospital stay up to 72 hoursPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
Time to patient first ambulation
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
First Ambulation
|
19.66 Hours
Standard Deviation 7.12
|
18.89 Hours
Standard Deviation 6.49
|
SECONDARY outcome
Timeframe: Duration of hospital stay up to 72 hoursPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
Time to first flatus
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
First Flatus
|
31.31 Hours
Standard Deviation 28.66
|
23.89 Hours
Standard Deviation 14.77
|
SECONDARY outcome
Timeframe: Duration of hospital stay up to 72 hoursPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
Time to first oral liquid intake
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Oral Liquid
|
6.24 Hours
Standard Deviation 6.16
|
4.46 Hours
Standard Deviation 2.85
|
SECONDARY outcome
Timeframe: Duration of hospital stay up to 72 hoursPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
Time to first oral food intake
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Oral Food
|
19.10 Hours
Standard Deviation 10.39
|
19.54 Hours
Standard Deviation 12.49
|
SECONDARY outcome
Timeframe: Duration of hospital stay up to 7 daysPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
Amount of time each subject spends in the hospital before discharge
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Hospital Length of Stay
|
3.27 days
Standard Deviation 2.12
|
2.84 days
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: 24 hours after surgeryPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
Assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied)
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Patient's Satisfaction Scores
Very Satisfied
|
33 Participants
|
28 Participants
|
|
Patient's Satisfaction Scores
Satisfied
|
17 Participants
|
16 Participants
|
|
Patient's Satisfaction Scores
Neutral
|
3 Participants
|
6 Participants
|
|
Patient's Satisfaction Scores
Unsatisfied
|
1 Participants
|
1 Participants
|
|
Patient's Satisfaction Scores
Very Unsatisfied
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 hours after surgeryPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control
Assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied)
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Patient's Satisfaction Scores
Very Satisfied
|
29 Participants
|
28 Participants
|
|
Patient's Satisfaction Scores
Satisfied
|
25 Participants
|
17 Participants
|
|
Patient's Satisfaction Scores
Neutral
|
1 Participants
|
5 Participants
|
|
Patient's Satisfaction Scores
Unsatisfied
|
1 Participants
|
1 Participants
|
|
Patient's Satisfaction Scores
Very Unsatisfied
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Duration of hospital stay up to 72 hoursPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
Incidence of urinary retention, ileus, spinal headache, pruritis, respiratory depression, injection site infection, nerve damage, hematoma, pneumothorax, lower extremity weakness.
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Number of Participants With Side Effects
urinary retention
|
2 participants
|
1 participants
|
|
Number of Participants With Side Effects
ileus
|
4 participants
|
1 participants
|
|
Number of Participants With Side Effects
pruritis
|
0 participants
|
0 participants
|
|
Number of Participants With Side Effects
respiratory depression
|
0 participants
|
0 participants
|
|
Number of Participants With Side Effects
injection site infection
|
0 participants
|
0 participants
|
|
Number of Participants With Side Effects
nerve damage
|
0 participants
|
0 participants
|
|
Number of Participants With Side Effects
hematoma
|
0 participants
|
0 participants
|
|
Number of Participants With Side Effects
pneumothorax
|
0 participants
|
0 participants
|
|
Number of Participants With Side Effects
lower extremity weakness
|
0 participants
|
0 participants
|
|
Number of Participants With Side Effects
spinal headache
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Duration of hospital stay up to 72 hoursPopulation: The baseline study population consists of adults aged 18 to 80 years (male or female) with an ASA physical status of 1, 2, or 3, a BMI less than 40 kg/m², and scheduled for an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital who desire regional anesthesia for postoperative pain control.
point in time of which had nausea
Outcome measures
| Measure |
IT Injection
n=56 Participants
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 Participants
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Nausea
1 hour after surgery · severe
|
0 Participants
|
0 Participants
|
|
Nausea
1 hour after surgery · moderate
|
1 Participants
|
0 Participants
|
|
Nausea
1 hour after surgery · mild
|
14 Participants
|
4 Participants
|
|
Nausea
1 hour after surgery · none
|
41 Participants
|
47 Participants
|
|
Nausea
12 hours after surgery · severe
|
0 Participants
|
1 Participants
|
|
Nausea
12 hours after surgery · moderate
|
4 Participants
|
3 Participants
|
|
Nausea
12 hours after surgery · mild
|
11 Participants
|
4 Participants
|
|
Nausea
12 hours after surgery · none
|
41 Participants
|
43 Participants
|
|
Nausea
24 hours after surgery · severe
|
0 Participants
|
1 Participants
|
|
Nausea
24 hours after surgery · mild
|
7 Participants
|
6 Participants
|
|
Nausea
24 hours after surgery · moderate
|
6 Participants
|
0 Participants
|
|
Nausea
24 hours after surgery · none
|
43 Participants
|
44 Participants
|
|
Nausea
48 hours after surgery · severe
|
1 Participants
|
1 Participants
|
|
Nausea
48 hours after surgery · moderate
|
3 Participants
|
0 Participants
|
|
Nausea
48 hours after surgery · mild
|
9 Participants
|
5 Participants
|
|
Nausea
48 hours after surgery · none
|
43 Participants
|
45 Participants
|
|
Nausea
72 hours after surgery · severe
|
0 Participants
|
1 Participants
|
|
Nausea
72 hours after surgery · moderate
|
2 Participants
|
2 Participants
|
|
Nausea
72 hours after surgery · mild
|
7 Participants
|
3 Participants
|
|
Nausea
72 hours after surgery · none
|
47 Participants
|
45 Participants
|
Adverse Events
IT Injection
ESP Block
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IT Injection
n=56 participants at risk
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
IT Injection: an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
|
ESP Block
n=51 participants at risk
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
ESP Block: an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
|
|---|---|---|
|
Nervous system disorders
spinal headache
|
1.8%
1/56 • Number of events 1 • We followed adverse events for 72 hours
|
0.00%
0/51 • We followed adverse events for 72 hours
|
|
Renal and urinary disorders
urinary retention
|
3.6%
2/56 • Number of events 2 • We followed adverse events for 72 hours
|
2.0%
1/51 • Number of events 1 • We followed adverse events for 72 hours
|
|
Gastrointestinal disorders
ileus
|
7.1%
4/56 • Number of events 4 • We followed adverse events for 72 hours
|
2.0%
1/51 • Number of events 1 • We followed adverse events for 72 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place