Trial Outcomes & Findings for Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery (NCT NCT01444924)

NCT ID: NCT01444924

Last Updated: 2019-11-27

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

24 hours

Results posted on

2019-11-27

Participant Flow

A total of 75 patients agreed to participate in the study. Eight patients did not meet inclusion criteria for the study, 2 patients were excluded from the analysis secondary to intraoperative conversion to laparotomy, and 1 additional patient was excluded because the robot was unavailable. This left a total of 64 subjects who completed the study.

Participant milestones

Participant milestones
Measure	Bupivicaine TAP block with bupivicaine/epinephrine placed prior to surgery. Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis	Placebo TAP block with placebo placed prior to surgery Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline.
Overall Study STARTED	31	33
Overall Study COMPLETED	31	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupivicaine n=31 Participants TAP block with bupivicaine/epinephrine placed prior to surgery. Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis	Placebo n=33 Participants TAP block with placebo placed prior to surgery Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline.	Total n=64 Participants Total of all reporting groups
Age, Continuous	55.2 years STANDARD_DEVIATION 11.48 • n=99 Participants	62.1 years STANDARD_DEVIATION 14.29 • n=107 Participants	58.7 years STANDARD_DEVIATION 14.29 • n=206 Participants
Sex: Female, Male Female	31 Participants n=99 Participants	33 Participants n=107 Participants	64 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) White	31 Participants n=99 Participants	29 Participants n=107 Participants	60 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	31 participants n=99 Participants	33 participants n=107 Participants	64 participants n=206 Participants
Body Mass Index (BMI)	34.2 kg/m^2 STANDARD_DEVIATION 12.12 • n=99 Participants	36.3 kg/m^2 STANDARD_DEVIATION 9.01 • n=107 Participants	35.3 kg/m^2 STANDARD_DEVIATION 12.32 • n=206 Participants

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Outcome measures
Measure	Bupivicaine n=31 Participants TAP block with bupivicaine/epinephrine placed prior to surgery. Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis	Placebo n=33 Participants TAP block with placebo placed prior to surgery Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline.
24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents	64.9 mg Standard Deviation 28.65	69.3 mg Standard Deviation 32.73

SECONDARY outcome

Timeframe: from 2 hours post-op to the afternoon/evening of post-op day #1

Pain scores by the Visual Analog Scale (VAS) \[0-5, where 0 is no pain and 5 is extreme\] and Wisconsin Brief Pain Inventory (BPI) \[where 0 is no pain and 10 is the most painful\], will be collected 3 times post-operatively (once the day of surgery (at least 2 hours post-op) and both the morning and afternoon/evening on post-operative day #1). Pain scores will be analyzed individually using the chi-squared test and linear regression. All statistical calculations used a two-sided significance level of 0.05 and were calculated using the R Project for Statistical Computing. VAS and BPI scores for each subject were averaged to provide a resultant VAS and BPI score.

Outcome measures

Outcome measures
Measure	Bupivicaine n=31 Participants TAP block with bupivicaine/epinephrine placed prior to surgery. Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis	Placebo n=33 Participants TAP block with placebo placed prior to surgery Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline.
Pain Scores VAS	3.12 units on a scale Interval 2.48 to 3.76	3.61 units on a scale Interval 2.88 to 4.35
Pain Scores BPI	6.44 units on a scale Interval 5.56 to 7.32	6.97 units on a scale Interval 6.15 to 7.79

Adverse Events

Bupivicaine

Serious events: 0 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

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Kushner

University of Wisconsin Hospitals and Clinics

Phone: 608-263-0796

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place