B&O for TLH Post-operative Pain and Nausea

Completed · Phase 4 · Has a placebo group

Conditions studied: Hysterectomy, Pain, Postoperative

In brief

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.

Key facts

Study ID

NCT03657407

Run by

Anna Reinert

People needed

56

Starts

2016-06-01

Expected to finish

2017-05-31

Last updated by the study team

2019-04-02

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• Mercy Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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