A Comparison of Exparel to Bupivacaine in TAP Block for Abdominal Gynecologic Surgery

NCT03304444 | Unknown Phase 3

• 1 other identifier: FWA00004123
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the comparison between liposomal bupivacaine versus bupivacaine HCl in Transversus Abdominis Plane blocks for gynecologic surgery on the length of stay in the hospital, total narcotic use, and overall complications rates.

Conditions

Gynecologic Cancer; Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Length of stay post operatively in hospital

  number of hours patient stays post operatively in hospital

  through study completion, expected to be approximately 1 year in total

Secondary Outcomes (1)

• total opioid use post operatively in hospital

  through study completion, expected to be approximately 1 year in total

Study Arms (2)

Bupivacaine HCl in TAP block

ACTIVE COMPARATOR

When performing a bilateral TAP with Bupivicaine 0.25% and the incision is below the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials). When performing a bilateral TAP with Bupivicaine 0.25% and the incision extends above the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials). A 3rd vial of 30 ml 0.25% bupivacaine will be drawn up and is directly infiltrated into the surgical site (above and below the fascia prior to closure of fascia) extending above the umbilicus by the surgeon.

Drug: Bupivacaine

Liposomal Bupivicaine in TAP block

EXPERIMENTAL

When performing a bilateral TAP with liposomal bupivacaine and the incision is below the umbilicus: the 20 ml vial of liposomal bupivacaine containing 266 mg, will be diluted with 20 ml of 0.25% bupivacaine (containing 50 mg of bupivacaine) and 20 ml saline (60 ml total). That total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks.

Drug: liposomal bupivacaine

Interventions

Bupivacaine DRUG

bupivacaine hydrochloride used in TAP block

Bupivacaine HCl in TAP block

liposomal bupivacaine DRUG

liposomal bupivacaine used in TAP block

Also known as: Exparel

Liposomal Bupivicaine in TAP block

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients undergoing planned exploratory laparotomy
• TAP blocks placed after the laparotomy incision is closed, but before the patient is awake, and placed under ultrasound guidance with correct identification of the correct abdominal plane.
• Consent for TAP block signed by patients preoperatively by anesthesiology

You may not qualify if:

• All pregnant patients
• All patients under 18 years of age
• minimally invasive surgery such as laparoscopy or robotic assisted laparoscopy
• medical contraindications to use of bupivacaine or liposomal bupivacaine such as severe hepatic and/or renal disease

Sponsors & Collaborators

• Abington Memorial Hospital: lead

Study Sites (1)

Abington Hospital Jefferson Health

Abington, Pennsylvania, 19001, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Heidi Ching, MD

  OB GYN Resident

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi Ching, MD

CONTACT

215-481-4231; heidi.ching@jefferson.edu

Mark Shahin, MD

CONTACT

215-885-0220; mark.shahin@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OBGYN Resident Physician

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: October 9, 2017
• Study Start: August 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 9, 2017

Record last verified: 2017-10

Locations

US (1)