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Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy

NCT02104414 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-12-04

Study results available
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Summary

The purpose of this study is to compare the quality and duration of pain relief after a hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more effective postoperative pain relief than both bupivacaine hcl and the control.

Conditions

  • Hemorrhoid

Interventions

DRUG

Exparel

266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)

DRUG

Bupivacaine HCl with Epinephrine

75mg/30mL 0.25% Bupivacaine HCl with epinephrine

DRUG

Normal Saline

30mL Normal Saline

Sponsors & Collaborators

  • St. Luke's-Roosevelt Hospital Center

    lead OTHER

Principal Investigators

  • Ali Shariat, MD · St. Luke's-Roosevelt Hospital Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-01-31
Completion
2016-01-31

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 NCT02104414 on ClinicalTrials.gov