Trial Outcomes & Findings for Transversus Abdominis Plane Blocks for Ileostomy Takedown: A Prospective Study (NCT NCT01411917)
NCT ID: NCT01411917
Last Updated: 2019-06-10
Results Overview
We aim to evaluate whether patients consume less opioids, over the first 24 hours post-operatively following ileostomy takedown, with the addition of a pre-operative Transversus Abdominis Plane (TAP) block for analgesia.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
24 hours
Results posted on
2019-06-10
Participant Flow
Participant milestones
| Measure |
TAP Block Group
Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
Placebo
Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
37
|
|
Overall Study
COMPLETED
|
32
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
TAP Block Group
Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
Placebo
Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
|---|---|---|
|
Overall Study
Patient did not undergo scheduled surger
|
0
|
1
|
Baseline Characteristics
Transversus Abdominis Plane Blocks for Ileostomy Takedown: A Prospective Study
Baseline characteristics by cohort
| Measure |
TAP Block Group
n=32 Participants
Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
Placebo
n=36 Participants
Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
39.4 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Body Mass Index (BMI) kg/m2
|
25.3 kg/m2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
25.1 kg/m2
STANDARD_DEVIATION 4.1 • n=7 Participants
|
25.2 kg/m2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
American Society of Anesthesiologists Physical Status Score (I-VI based on Health of Patient)
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
2 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursWe aim to evaluate whether patients consume less opioids, over the first 24 hours post-operatively following ileostomy takedown, with the addition of a pre-operative Transversus Abdominis Plane (TAP) block for analgesia.
Outcome measures
| Measure |
TAP Block Group
n=30 Participants
Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
Placebo
n=35 Participants
Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
|---|---|---|
|
24 Hour Postoperative Opioid Consumption
|
57.7 mg
Standard Deviation 49.3
|
77.8 mg
Standard Deviation 46.8
|
SECONDARY outcome
Timeframe: Surgical PACU (Approximately 2 hours post-anesthesia)0-10 Pain Scale Numerical Rating Pain Scale. 0 represents no pain and 10 represents the worst pain imaginable.
Outcome measures
| Measure |
TAP Block Group
n=32 Participants
Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
Placebo
n=36 Participants
Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
|---|---|---|
|
Pain Scores at Post-anesthesia Care Unit (PACU) Discharge
|
3.3 units on a scale
Standard Deviation 1.8
|
3.8 units on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 24 hours post-block0-10 Pain Scale Numerical Rating Pain Scale. 0 represents no pain and 10 represents the worst pain imaginable.
Outcome measures
| Measure |
TAP Block Group
n=30 Participants
Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
Placebo
n=35 Participants
Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
|---|---|---|
|
Pain Scores at 24 Hours Post-block
|
3.1 units on a scale
Standard Deviation 2
|
2.5 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Approximately two hours post-anesthesiaOutcome measures
| Measure |
TAP Block Group
n=32 Participants
Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
Placebo
n=36 Participants
Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
|---|---|---|
|
Time From PACU Recovery Room Admission Until Meeting Recovery Room Discharge Criteria
|
29 Minutes
Standard Deviation 56.4
|
18 Minutes
Standard Deviation 37.4
|
SECONDARY outcome
Timeframe: Approximately 2-3 hours after block/placebo placementMorphine Equivalents
Outcome measures
| Measure |
TAP Block Group
n=32 Participants
Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
Placebo
n=36 Participants
Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
|---|---|---|
|
Intra-operative Opioid Use
|
31.1 mg
Standard Deviation 14.1
|
28.6 mg
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Approximately two hours post-anesthesiaMorphine Equivalents
Outcome measures
| Measure |
TAP Block Group
n=32 Participants
Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
Placebo
n=36 Participants
Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
|---|---|---|
|
PACU Opioid Use
|
8.8 mg
Standard Deviation 7.6
|
12.9 mg
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
TAP Block Group
n=30 Participants
Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
Placebo
n=35 Participants
Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
|---|---|---|
|
Incidence of Post-operative Nausea
|
10 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Hours that patient spends in the hospital for their surgical procedure.This outcome is intended to assess the impact of the regional anesthesia technique on the amount of time that patients stayed in the hospital following their surgical procedure. This outcome is measured in hours.
Outcome measures
| Measure |
TAP Block Group
n=30 Participants
Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
Placebo
n=35 Participants
Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
|---|---|---|
|
Time to Hospital Discharge
|
107.4 hours
Standard Deviation 58.4
|
97.6 hours
Standard Deviation 60.4
|
Adverse Events
TAP Block Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAP Block Group
n=32 participants at risk
Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
Placebo
n=36 participants at risk
Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.
Transversus abdominis plane block: Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
|
|---|---|---|
|
Cardiac disorders
Postoperative Myocardial Infarction
|
3.1%
1/32 • Number of events 1
|
0.00%
0/36
|
Other adverse events
Adverse event data not reported
Additional Information
Kristopher Schroeder
University of Wisconsin School of Medicine, Department of Anesthesiology
Phone: 608-232-1542
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place