Trial Outcomes & Findings for Trial Comparing Transversus Abdominis Plane Block Versus Epidural Anesthesia for Pain Management in Colorectal Surgery (NCT NCT02591407)
NCT ID: NCT02591407
Last Updated: 2026-01-28
Results Overview
Measured by patient completing the Numeric Pain Scale (NPS) on post-operative day 0,1,2,3. Numeric Pain Scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Data from all the specified time points above (post-operative day 0,1,2,3) was averaged into a single value.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Post-operative day 0,1,2,3
Results posted on
2026-01-28
Participant Flow
Participant milestones
| Measure |
Continuous Epidural Analgesia
Continuous Epidural Analgesia
Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion
|
TAP Block- Exparel
Transversus abdominis plane block utilizing the medication Exparel®
TAP Block: This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
|
|---|---|---|
|
Follow-up
COMPLETED
|
87
|
92
|
|
Follow-up
NOT COMPLETED
|
2
|
2
|
|
Randomization
STARTED
|
101
|
99
|
|
Randomization
COMPLETED
|
89
|
94
|
|
Randomization
NOT COMPLETED
|
12
|
5
|
|
Follow-up
STARTED
|
89
|
94
|
|
Analysis
STARTED
|
87
|
92
|
|
Analysis
COMPLETED
|
87
|
92
|
|
Analysis
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Continuous Epidural Analgesia
Continuous Epidural Analgesia
Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion
|
TAP Block- Exparel
Transversus abdominis plane block utilizing the medication Exparel®
TAP Block: This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
|
|---|---|---|
|
Randomization
Cancelled surgery
|
5
|
3
|
|
Randomization
Withdrawal by Subject
|
7
|
1
|
|
Randomization
Emergency surgery
|
0
|
1
|
|
Follow-up
Lost to Follow-up
|
1
|
0
|
|
Follow-up
Protocol Violation
|
1
|
2
|
Baseline Characteristics
Trial Comparing Transversus Abdominis Plane Block Versus Epidural Anesthesia for Pain Management in Colorectal Surgery
Baseline characteristics by cohort
| Measure |
TAP Block- Exparel
n=92 Participants
Transversus abdominis plane block utilizing the medication Exparel®
TAP Block: This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
|
Continuous Epidural Analgesia
n=87 Participants
Continuous Epidural Analgesia
Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion
|
Total
n=179 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.05 years
STANDARD_DEVIATION 11.79 • n=158 Participants
|
62.06 years
STANDARD_DEVIATION 11.12 • n=157 Participants
|
62.05 years
STANDARD_DEVIATION 11.45 • n=315 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=158 Participants
|
34 Participants
n=157 Participants
|
76 Participants
n=315 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=158 Participants
|
53 Participants
n=157 Participants
|
103 Participants
n=315 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=158 Participants
|
8 Participants
n=157 Participants
|
14 Participants
n=315 Participants
|
|
Race/Ethnicity, Customized
White
|
85 Participants
n=158 Participants
|
77 Participants
n=157 Participants
|
162 Participants
n=315 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
|
Region of Enrollment
United States
|
92 participants
n=158 Participants
|
87 participants
n=157 Participants
|
179 participants
n=315 Participants
|
|
Tobacco use
|
12 Participants
n=158 Participants
|
15 Participants
n=157 Participants
|
27 Participants
n=315 Participants
|
|
Alcohol use
|
1 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
3 Participants
n=315 Participants
|
|
Steroids use
|
2 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
4 Participants
n=315 Participants
|
|
Opioid use
|
1 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
|
Hypertension
|
51 Participants
n=158 Participants
|
48 Participants
n=157 Participants
|
99 Participants
n=315 Participants
|
|
Coronary artery disease
|
11 Participants
n=158 Participants
|
8 Participants
n=157 Participants
|
19 Participants
n=315 Participants
|
|
Congestive heart failure
|
5 Participants
n=158 Participants
|
4 Participants
n=157 Participants
|
9 Participants
n=315 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
|
4 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
7 Participants
n=315 Participants
|
|
Sleep apnea
|
8 Participants
n=158 Participants
|
7 Participants
n=157 Participants
|
15 Participants
n=315 Participants
|
|
Diabetes mellitus
|
13 Participants
n=158 Participants
|
15 Participants
n=157 Participants
|
28 Participants
n=315 Participants
|
|
Renal disease
|
2 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
7 Participants
n=315 Participants
|
|
Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE)
|
8 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
9 Participants
n=315 Participants
|
|
Disseminated cancer
|
5 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
10 Participants
n=315 Participants
|
|
Previous abdominal surgery
|
41 Participants
n=158 Participants
|
30 Participants
n=157 Participants
|
71 Participants
n=315 Participants
|
PRIMARY outcome
Timeframe: Post-operative day 0,1,2,3Measured by patient completing the Numeric Pain Scale (NPS) on post-operative day 0,1,2,3. Numeric Pain Scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Data from all the specified time points above (post-operative day 0,1,2,3) was averaged into a single value.
Outcome measures
| Measure |
Continuous Epidural Analgesia
n=87 Participants
Continuous Epidural Analgesia
Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion
|
TAP Block- Exparel
n=92 Participants
Transversus abdominis plane block utilizing the medication Exparel®
TAP Block: This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
|
|---|---|---|
|
Post-operative Mean Numeric Pain Scale.
|
2.12 units on a scale
Standard Deviation 1.44
|
2.32 units on a scale
Standard Deviation 1.44
|
PRIMARY outcome
Timeframe: Post-operative day 0,1,2,3Measured by the patient completing the OBAS survey on postoperative days 0,1,2,3. The OBAS is a multi-dimensional quality assessment instrument to measure patients' benefit from postoperative pain therapy. 1\. Rate your current pain at rest on a scale between 0=minimal pain and 4=maximum imaginable pain 2-6. Grade any distress and bother from vomiting in the past 24 h (0=not at all to 4=very much: same scale for remaining Qs about itching, sweating, freezing, dizziness on the scale). 7\. Rate your satisfaction with your pain treatment on a scale between 0=not at all and 4= very much To calculate the OBAS score, compute the sum of scores in items 1-6 and add the '4-(score in item 7)'. The range of scores is from 0 (best) to 28 (worst). Data from all the specified time points above (post-operative day 0,1,2,3) was averaged into a single value.
Outcome measures
| Measure |
Continuous Epidural Analgesia
n=87 Participants
Continuous Epidural Analgesia
Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion
|
TAP Block- Exparel
n=92 Participants
Transversus abdominis plane block utilizing the medication Exparel®
TAP Block: This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
|
|---|---|---|
|
Overall Benefits of Analgesia Score (OBAS)
|
0.48 units on a scale
Standard Deviation 0.52
|
0.37 units on a scale
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Post-operative day 0Patient use of narcotic analgesia post-operative day 0 including Fentanyl from epidural
Outcome measures
| Measure |
Continuous Epidural Analgesia
n=87 Participants
Continuous Epidural Analgesia
Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion
|
TAP Block- Exparel
n=92 Participants
Transversus abdominis plane block utilizing the medication Exparel®
TAP Block: This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
|
|---|---|---|
|
Patient Use of Narcotic Analgesia Post-op Day 0
|
80.20 Morphine milligram equivalents
Interval 58.41 to 110.12
|
54.64 Morphine milligram equivalents
Interval 50.35 to 59.31
|
SECONDARY outcome
Timeframe: Post-operative day 0Patient use of narcotic analgesia post operative day 0 excluding Fentanyl from epidural.
Outcome measures
| Measure |
Continuous Epidural Analgesia
n=87 Participants
Continuous Epidural Analgesia
Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion
|
TAP Block- Exparel
n=92 Participants
Transversus abdominis plane block utilizing the medication Exparel®
TAP Block: This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
|
|---|---|---|
|
Patient Use of Narcotic Analgesia Post-operative Day 0
|
27.55 Morphine milligram equivalents
Interval 20.77 to 36.55
|
54.64 Morphine milligram equivalents
Interval 50.35 to 59.31
|
SECONDARY outcome
Timeframe: Post-operative day 3Patient use of narcotic analgesia post-operative day 3 including Fentanyl from epidural
Outcome measures
| Measure |
Continuous Epidural Analgesia
n=87 Participants
Continuous Epidural Analgesia
Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion
|
TAP Block- Exparel
n=92 Participants
Transversus abdominis plane block utilizing the medication Exparel®
TAP Block: This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
|
|---|---|---|
|
Patient Use of Narcotic Analgesia Post-operative Day 3
|
0.34 Morphine milligram equivalents
Interval 0.15 to 0.77
|
0.22 Morphine milligram equivalents
Interval 0.1 to 0.45
|
SECONDARY outcome
Timeframe: Post-operative day 1Patient use of narcotic analgesia post operative day 1 including Fentanyl from epidural
Outcome measures
| Measure |
Continuous Epidural Analgesia
n=87 Participants
Continuous Epidural Analgesia
Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion
|
TAP Block- Exparel
n=92 Participants
Transversus abdominis plane block utilizing the medication Exparel®
TAP Block: This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
|
|---|---|---|
|
Patient Use of Narcotic Analgesia Post-operative Day 1
|
71 Morphine milligram equivalents
Interval 53.42 to 94.36
|
13.34 Morphine milligram equivalents
Interval 8.14 to 21.86
|
SECONDARY outcome
Timeframe: Post-operative day 2Patient use of narcotic analgesia post operative day 2 including Fentanyl from epidural
Outcome measures
| Measure |
Continuous Epidural Analgesia
n=87 Participants
Continuous Epidural Analgesia
Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion
|
TAP Block- Exparel
n=92 Participants
Transversus abdominis plane block utilizing the medication Exparel®
TAP Block: This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
|
|---|---|---|
|
Patient Use of Narcotic Analgesia Post-operative Day 2
|
3.11 Morphine milligram equivalents
Interval 1.52 to 6.38
|
2.61 Morphine milligram equivalents
Interval 1.33 to 5.14
|
Adverse Events
Continuous Epidural Analgesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TAP Block- Exparel
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place