Trial Outcomes & Findings for TAP Block With Plain Bupivacaine Versus Wound Infiltration With Exparel for Postoperative Pain Management (NCT NCT02074709)

Results Overview

Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

Participants' pain score was assessed at 6 hr after surgery

Results posted on

2018-06-04

A total of 67 patients were assessed for eligibility and 60 patient enrolled to the study.

Participant milestones
Measure	TAP Block TAP block with plain bupivacaine Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV . First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine. 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn	Wound Infiltration Wound infiltration with liposomal bupivacaine Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn
Overall Study STARTED	30	30
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	1	1

Withdrawal data not reported

TAP Block With Plain Bupivacaine Versus Wound Infiltration With Exparel for Postoperative Pain Management

Baseline characteristics by cohort
Measure	TAP Block n=29 Participants TAP block with plain bupivacaine	Wound Infiltration n=29 Participants Wound infiltration with liposomal bupivacaine	Total n=58 Participants Total of all reporting groups
Age, Continuous	43.6 years STANDARD_DEVIATION 6.4 • n=5 Participants	44.4 years STANDARD_DEVIATION 6.1 • n=7 Participants	44 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants

Timeframe: Participants' pain score was assessed at 6 hr after surgery

Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)

Outcome measures
Measure	TAP Block n=29 Participants TAP block with plain bupivacaine Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .	Wound Infiltration n=29 Participants Wound infiltration with liposomal bupivacaine Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV
Postoperative Pain Score on Coughing at 6 hr	5.28 units on a scale Standard Deviation 2.45	3.59 units on a scale Standard Deviation 1.70

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Texas Southwestern Medical Center

Phone: 214-590-0064