Trial Outcomes & Findings for Evaluation of a TAP Block Given During Laparoscopic Colorectal Surgery to Help Control Pain (NCT NCT01731782)

NCT ID: NCT01731782

Last Updated: 2022-11-03

Results Overview

Pain measured via score of 1 to 5, with 1 being no pain and 5 being the worst pain

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 79 participants
• Primary outcome timeframe: up to 10 days
• Results posted on: 2022-11-03

Participant Flow

Participant milestones

Measure	Bupivacaine bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml bupivacaine	Normal Saline Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine
Overall Study STARTED	41	38
Overall Study COMPLETED	41	38
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a TAP Block Given During Laparoscopic Colorectal Surgery to Help Control Pain

Baseline characteristics by cohort

Measure	Bupivacaine n=41 Participants bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml bupivacaine	Normal Saline n=38 Participants Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine	Total n=79 Participants Total of all reporting groups
Age, Continuous	67.34 Years STANDARD_DEVIATION 14.16 • n=5 Participants	64.82 Years STANDARD_DEVIATION 13.11 • n=7 Participants	66.12 Years STANDARD_DEVIATION 13.65 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 10 days

Pain measured via score of 1 to 5, with 1 being no pain and 5 being the worst pain

Outcome measures

Measure	Bupivacaine n=41 Participants bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml bupivacaine	Normal Saline n=38 Participants Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine
Postoperative Pain as Measured by Pain Score	2.60 score on a scale Standard Deviation 2.09	3.46 score on a scale Standard Deviation 1.92

SECONDARY outcome

Timeframe: Up to 30 days after surgery

Outcome measures

Measure	Bupivacaine n=41 Participants bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml bupivacaine	Normal Saline n=38 Participants Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine
Percent of Analgesics Used as Measured by Patient Report	0.80 percentage of analgesics used Standard Deviation 0.52	1.79 percentage of analgesics used Standard Deviation 0.72

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 10 days

Outcome measures

Measure	Bupivacaine n=41 Participants bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml bupivacaine	Normal Saline n=38 Participants Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine
Number of Nausea/Vomiting Episodes	10 Episodes	9 Episodes

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 10 days

Outcome measures

Measure	Bupivacaine n=41 Participants bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml bupivacaine	Normal Saline n=38 Participants Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine
Length of Hospital Stay	3.15 days Standard Deviation 2.03	2.87 days Standard Deviation 1.58

OTHER_PRE_SPECIFIED outcome

Timeframe: daily after surgery until discharge up to 10 days

Log the day bowel function returns by day postoperative that flatus returns and has first stool

Outcome measures

Outcome data not reported

Adverse Events

Bupivacaine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bupivacaine n=41 participants at risk bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml bupivacaine	Normal Saline n=38 participants at risk Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine
Cardiac disorders Myocardial infarction	2.4% 1/41 • Number of events 1 • Up to 30 days postop	0.00% 0/38 • Up to 30 days postop

Other adverse events

Adverse event data not reported

Additional Information

Dr. Conor Delaney

Cleveland Clinic Florida Region

Phone: 954-659-6001

Email: DELANEC@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place