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B&O for TLH Post-operative Pain and Nausea

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ClinicalTrials.gov Identifier: NCT03657407
Recruitment Status : Completed
First Posted : September 5, 2018
Results First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
University of Maryland, College Park
Information provided by (Responsible Party):
Anna Reinert, Mercy Medical Center

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.

Condition or disease Intervention/treatment Phase
Hysterectomy Pain, Postoperative Drug: Belladonna Opium Drug: Glycerin Suppository Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Belladonna and Opium Rectal Suppository Effect on Postoperative Pain and Nausea Following Total Laparoscopic and Robotic-Assisted Hysterectomy
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: B&O
29 women randomized to Belladonna & Opium suppository
Drug: Belladonna Opium
Belladonna Opium 16.2-60mg rectal suppository

Sham Comparator: Placebo
27 women randomized to Glycerin suppository
Drug: Glycerin Suppository
Glycerine rectal suppository




Primary Outcome Measures :
  1. Post-operative Pain: VAS [ Time Frame: up to 4 hours ]
    Visual analog pain scale (VAS) (0 to 10, 0 = no pain, 10 = maximum pain), averaged over duration of PACU stay until discharge criteria met


Secondary Outcome Measures :
  1. Narcotic Use [ Time Frame: up to 4 hours ]
    Cumulative oral and intravenous narcotics received in PACU until PACU discharge criteria met

  2. Time Until Cleared for PACU Discharge [ Time Frame: up to 4 hours ]
    Time elapsed from conclusion of surgery until criteria for PACU discharge met

  3. Number of Participants for Which Anti-emetics Were Received in PACU [ Time Frame: up to 4 hours ]
    Binary assessment of whether anti-emetics received in PACU



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657407


Locations
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United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Anna Reinert
University of Maryland, College Park
Investigators
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Principal Investigator: Kevin Audlin, MD Surgeon
  Study Documents (Full-Text)

Documents provided by Anna Reinert, Mercy Medical Center:

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Responsible Party: Anna Reinert, Study coordinator, Resident Physician, Mercy Medical Center
ClinicalTrials.gov Identifier: NCT03657407     History of Changes
Other Study ID Numbers: MMC 2015-63
First Posted: September 5, 2018    Key Record Dates
Results First Posted: April 2, 2019
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Opium
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidiarrheals
Gastrointestinal Agents
Antitussive Agents
Respiratory System Agents