B&O for TLH Post-operative Pain and Nausea

NCT03657407 | Completed Phase 4 Results FDA Drug

• 1 other identifier: MMC 2015-63
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Post-operative Pain: VAS

  Visual analog pain scale (VAS) (0 to 10, 0 = no pain, 10 = maximum pain), averaged over duration of PACU stay until discharge criteria met

  up to 4 hours

Secondary Outcomes (3)

• Narcotic Use

  up to 4 hours

• Time Until Cleared for PACU Discharge

  up to 4 hours

• Number of Participants for Which Anti-emetics Were Received in PACU

  up to 4 hours

Study Arms (2)

B&O

ACTIVE COMPARATOR

29 women randomized to Belladonna \& Opium suppository

Drug: Belladonna Opium

Placebo

SHAM COMPARATOR

27 women randomized to Glycerin suppository

Drug: Glycerin Suppository

Interventions

Belladonna Opium DRUG

Belladonna Opium 16.2-60mg rectal suppository

B&O

Glycerin Suppository DRUG

Glycerine rectal suppository

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between ages 18 and 75,
• undergoing level I total laparoscopic or robot-assisted hysterectomy with or without bilateral salpingo-oophorectomy, cystoscopy, lysis of adhesions, or surgical treatment of endometriosis

You may not qualify if:

• contraindications to the use of B\&O (i.e. glaucoma, severe hepatic or renal disease, bronchial asthma, history of narcotic idiosyncracies, respiratory depression, convulsive disorders, acute alcoholism or delirium tremens, or regular use of an anticholinergic medication (twice per week or more frequently)
• additional surgical procedures being performed

Sponsors & Collaborators

• Anna Reinert: lead
• University of Maryland: collaborator

Study Sites (1)

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study was limited by low power; sample size at 50% of target by power calculations. Pre-operative scopolamine patch use was not controlled within study randomization, and varied significantly between groups.

Results Point of Contact

• Title: Anna Reinert, MD
• Organization: University of Maryland Medical Center

anna.reinert@gmail.com

6029089960

Study Officials

• Kevin Audlin, MD

  Surgeon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Opaque sealed envelopes generated by biostatistician used to determine intervention A or B. Drug dictionary entries created within the Pyxis system by the Mercy Medical Center Department of Pharmacy, as "Protocol Drug A" and "Protocol Drug B", recorded in medical record in this way. Identity of "Protocol Drug A" and "Protocol Drug B" revealed by pharmacist at conclusion of data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study coordinator, Resident Physician

Model Details: Randomization to one-time intervention A (medicated suppository) or intervention B (placebo), allocation was sealed in consecutively numbered opaque envelopes generated by biostatistician using blocked randomized technique.

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 5, 2018
• Study Start: June 1, 2016
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: April 2, 2019
• Results First Posted: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)