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B&O for TLH Post-operative Pain and Nausea

NCT03657407 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-04-02

Study results available
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Summary

A prospective, single-center, double-blind, randomized, placebo-controlled trial to assess the impact of immediate post-operative placement of a Belladonna and Opium (B\&O) rectal suppository on postoperative pain and nausea following laparoscopic and robot-assisted hysterectomy.

Conditions

  • Hysterectomy
  • Pain, Postoperative

Interventions

DRUG

Belladonna Opium

Belladonna Opium 16.2-60mg rectal suppository

DRUG

Glycerin Suppository

Glycerine rectal suppository

Sponsors & Collaborators

  • University of Maryland

    collaborator OTHER

  • Anna Reinert

    lead OTHER

Principal Investigators

  • Kevin Audlin, MD · Surgeon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2017-05-31
Completion
2017-05-31
FDA Drug
Yes

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 NCT03657407 on ClinicalTrials.gov