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Randomized Trial of Wound Infiltration With Extended-release Bupivacaine Before Laparoscopic or Robotic Hysterectomy

NCT02352922 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-10-01

Study results available
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Summary

The investigators are studying ways to improve pain control after surgery. One way to decrease pain is to inject incisions with a numbing medicine (local anesthetic) while in the operating room. There is an FDA approved extended-release version of a commonly used local anesthetic (bupivacaine) that can last for 4 days instead of 6 hours. The investigators are studying whether using the extended-release medication (Exparel) will give better pain relief after laparoscopic and robotic-assisted hysterectomies.

Conditions

  • Pain, Postoperative
  • Surgical Procedure, Unspecified

Interventions

DRUG

Liposomal Bupivacaine

pre-incision infiltration with liposomal bupivacaine

DRUG

Bupivacaine HCl

pre-incision infiltration with bupivacaine HCl

Sponsors & Collaborators

  • AdventHealth

    lead OTHER

Principal Investigators

  • Georgine Lamvu, MD, MPH · Florida Hospital Orlando

  • Kenneth I Barron, MD · Florida Hospital Orlando

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-01-31
Completion
2016-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02352922 on ClinicalTrials.gov