Phase 4
N=56
B&O for TLH Post-operative Pain and Nausea
Hysterectomy · Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03657407 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Post-operative Pain: VAS — 4.1; 4.8 score on a scale — p=0.17
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Belladonna Opium (Drug); Glycerin Suppository (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Anna Reinert
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Pain: VAS |
4.1; 4.8 | 0.17 |
| SECONDARY Narcotic Use |
19.3; 21.3 | 0.29 |
| SECONDARY Time Until Cleared for PACU Discharge |
91.3; 110.6 | 0.05 |
| SECONDARY Number of Participants for Which Anti-emetics Were Received in PACU |
10; 11 | 0.42 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03657407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.