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

NCT02074709 | Completed Phase 4 Results DMC

• 1 other identifier: 072013-080
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized, controlled, observer-blinded study we plan to evaluate pain relief after ultrasound-guided transversus abdominis plane (TAP) block using bupivacaine and wound infiltration using liposomal bupivacaine in patients undergoing abdominal hysterectomy.

Conditions

Postoperative Pain

Keywords

Pain, Liposomal bupivacaine, Wound infiltration

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score on Coughing at 6 hr

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

  Participants' pain score was assessed at 6 hr after surgery

Study Arms (2)

TAP block

ACTIVE COMPARATOR

TAP block with plain bupivacaine

Drug: Plain bupivacaine

Wound infiltration

ACTIVE COMPARATOR

Wound infiltration with liposomal bupivacaine

Drug: Liposomal bupivacaine

Interventions

Plain bupivacaine DRUG

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

Also known as: Bupivacaine Hydrochloride

TAP block

Liposomal bupivacaine DRUG

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

Also known as: Exparel

Wound infiltration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• ASA physical status 1-3
• Scheduled for open abdominal hysterectomy
• Age 18-80 years old
• Able to participate personally or by legal representative in informed consent in English or Spanish

You may not qualify if:

• History of relevant drug allergy
• Age less than 18 or greater than 80 years
• Chronic opioid use or drug abuse
• Significant psychiatric disturbance
• Inability to understand the study protocol
• Refusal to provide written consent

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UTSW, Parkland Health Hospital System

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Irina Gasanova
• Organization: University of Texas Southwestern Medical Center

Irina.Gasanova@UTSouthwestern.edu

214-590-0064

Study Officials

• Irina Gasanova, MD., PhD.

  UTexas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: February 28, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: February 1, 2015
• Last Updated: June 4, 2018
• Results First Posted: December 17, 2014

Record last verified: 2018-05

Locations

US (1)