Trial Outcomes & Findings for Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery (NCT NCT01479270)
NCT ID: NCT01479270
Last Updated: 2018-10-11
Results Overview
40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
Postop Day #1 or Day #2
Results posted on
2018-10-11
Participant Flow
Participant milestones
| Measure |
Tap Block
Patients undergoing Total Laparoscopic Hysterectomy were randomized with the Tap Block
|
No Block
Patients undergoing Total Laparoscopic Hysterectomy were randomized without Tap Block
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery
Baseline characteristics by cohort
| Measure |
Tap Block
n=28 Participants
Patients randomized to either Tap Block or No Tap Block
|
No Block
n=28 Participants
Patients randomized to either Tap Block or No Tap Block
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postop Day #1 or Day #240 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery).
Outcome measures
| Measure |
TAP Block
n=28 Participants
20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance.
TAP Block of 0.25% Ropivacaine with 1:200,000 Epinephrine: Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia
|
No Block
n=28 Participants
Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.
|
|---|---|---|
|
Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2
|
168.0 units on a scale
Interval 125.0 to 195.0
|
169.5 units on a scale
Interval 116.0 to 194.0
|
SECONDARY outcome
Timeframe: Postop Day #0 and Day #1narcotic use in mg of Morphine will be recorded
Outcome measures
| Measure |
TAP Block
n=28 Participants
20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance.
TAP Block of 0.25% Ropivacaine with 1:200,000 Epinephrine: Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia
|
No Block
n=28 Participants
Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.
|
|---|---|---|
|
Narcotic Use
Post operative day #0
|
11.7 mg of morphine
Interval 0.0 to 24.0
|
11.8 mg of morphine
Interval 0.0 to 27.0
|
|
Narcotic Use
Post operative day #1
|
7.5 mg of morphine
Interval 3.0 to 25.0
|
9.0 mg of morphine
Interval 3.0 to 15.0
|
SECONDARY outcome
Timeframe: 2 and 24 hours post operativevisual analogue scales for pain will be completed on post-operative day #0 and #1, pain is assessed on a 10-point visual analogue scale (0 = no pain; 1 to 3 = mild; 4 to 6 = moderate pain; 7 to 10 = severe pain.)
Outcome measures
| Measure |
TAP Block
n=28 Participants
20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance.
TAP Block of 0.25% Ropivacaine with 1:200,000 Epinephrine: Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia
|
No Block
n=28 Participants
Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.
|
|---|---|---|
|
Visual Analog Scale (VAS) for Pain
2 hours post operative
|
5.0 units on a scale
Interval 0.0 to 10.0
|
6.0 units on a scale
Interval 2.0 to 10.0
|
|
Visual Analog Scale (VAS) for Pain
24 hours post operative
|
5.0 units on a scale
Interval 0.0 to 8.0
|
5.0 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: the total intraoperative time in minutesThe total time in the operating room will be recorded to see if there is a difference between groups.
Outcome measures
| Measure |
TAP Block
n=28 Participants
20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance.
TAP Block of 0.25% Ropivacaine with 1:200,000 Epinephrine: Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia
|
No Block
n=28 Participants
Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.
|
|---|---|---|
|
Intraoperative Time
|
47.4 Minutes
Interval 2.4 to 108.6
|
34.5 Minutes
Interval 10.8 to 109.8
|
Adverse Events
TAP Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Block
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