Trial Outcomes & Findings for Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery (NCT NCT01075074)

Results Overview

The quality of recovery questionnaire (QOR40) is a 40 question assessment of patient recovery following surgery. It evaluates 5 domains of recovery: pain, emotional status, physical comfort, physical independence, and support. Each question is scores on a 1 to 5 Likert scale with total scores ranging for 40, representing poor recovery, to 200, representing outstanding recovery.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

24 hours after surgery

Results posted on

2013-11-21

Participant Flow

Recruited from Prentice Women's Hospital consecutively from 04/01/2010-02/2011

Participant milestones

Participant milestones
Measure	Ropivacaine 0.05% Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine	Normal Saline Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline	Ropivacaine 0.25% Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
Overall Study STARTED	25	25	25
Overall Study COMPLETED	24	23	23
Overall Study NOT COMPLETED	1	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Ropivacaine 0.05% Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine	Normal Saline Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline	Ropivacaine 0.25% Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
Overall Study Surgeon changed to open incisional case	1	2	2

Baseline Characteristics

Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ropivacaine 0.05% n=25 Participants Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine	Normal Saline n=25 Participants Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline	Ropivacaine 0.25% n=25 Participants Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%	Total n=75 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	75 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	38 years STANDARD_DEVIATION 8 • n=5 Participants	38 years STANDARD_DEVIATION 10 • n=7 Participants	35 years STANDARD_DEVIATION 9 • n=5 Participants	37 years STANDARD_DEVIATION 9 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	75 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	25 participants n=5 Participants	75 participants n=4 Participants

PRIMARY outcome

Timeframe: 24 hours after surgery

Population: 75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.

The quality of recovery questionnaire (QOR40) is a 40 question assessment of patient recovery following surgery. It evaluates 5 domains of recovery: pain, emotional status, physical comfort, physical independence, and support. Each question is scores on a 1 to 5 Likert scale with total scores ranging for 40, representing poor recovery, to 200, representing outstanding recovery.

Outcome measures

Outcome measures
Measure	Ropivacaine 0.5% n=24 Participants The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side	Normal Saline n=23 Participants The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.	Ropivacaine 0.25% n=23 Participants The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery	172 units on a scale Interval 160.0 to 190.0	157 units on a scale Interval 148.0 to 169.0	173 units on a scale Interval 165.0 to 189.0

SECONDARY outcome

Timeframe: Post Operative

Population: 75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.

Area under the numeric rating scale for pain versus time (min) curve during the post anesthesia care admission. Numeric rating scale 0 to 10 with 0 equals no pain and 10 equals worst pain imaginable.

Outcome measures

Outcome measures
Measure	Ropivacaine 0.5% n=24 Participants The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side	Normal Saline n=23 Participants The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.	Ropivacaine 0.25% n=23 Participants The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
Pain Burden During Early Recovery From Anesthesia	210 score on a scale * minutes Inter-Quartile Range 4 • Interval 90.0 to 345.0	405 score on a scale * minutes Inter-Quartile Range 4 • Interval 360.0 to 502.0	210 score on a scale * minutes Inter-Quartile Range 4 • Interval 135.0 to 365.0

SECONDARY outcome

Timeframe: 24 hours

Population: 75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.

Opioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge

Outcome measures

Outcome measures
Measure	Ropivacaine 0.5% n=21 Participants The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side	Normal Saline n=23 Participants The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.	Ropivacaine 0.25% n=22 Participants The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
Opioid Pain Medications Consumed During the First 24 Hours Post Surgery	40 mEq of PO morphine equivalent Interval 13.0 to 72.0	78 mEq of PO morphine equivalent Interval 61.0 to 90.0	39 mEq of PO morphine equivalent Interval 25.0 to 58.0

SECONDARY outcome

Timeframe: 24 hours

Population: 75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.

Elapsed time from post anesthesia care unit to readiness to hospital discharge. Assessment were made using the modified post anesthetic discharge scoring system. This assess 5 criteria: vital signs, activity and mental status, pain nausea and/or vomiting, surgical bleed, and intake and output. A score greater than or equal to 9 (on a 0 to 10 scale) is considered ready for discharge.

Outcome measures

Outcome measures
Measure	Ropivacaine 0.5% n=24 Participants The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side	Normal Saline n=23 Participants The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.	Ropivacaine 0.25% n=23 Participants The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
Time to Hospital Discharge Readiness	90 minutes Interval 75.0 to 120.0	120 minutes Interval 105.0 to 150.0	90 minutes Interval 75.0 to 135.0

Adverse Events

Ropivacaine 0.5%

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Ropivacaine 0.25%

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ropivacaine 0.5% n=25 participants at risk Subjects received a bilateral transversus abdominis plane block using 15 cc of 0.5% ropivacaine	Normal Saline n=25 participants at risk Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline.	Ropivacaine 0.25% n=25 participants at risk Subjects received a bilateral transversus abdominis plane block using 15cc of ropivicaine 0.25%
Gastrointestinal disorders Nausea	50.0% 12/24 • Number of events 12 • Post anesthesia care unit until discharge	47.8% 11/23 • Number of events 11 • Post anesthesia care unit until discharge	52.2% 12/23 • Number of events 12 • Post anesthesia care unit until discharge

Additional Information

Gildasio De Oliveira, MD

Northwestern University

Phone: 312-926-8373

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place