Phase 4 Completed N=56 Randomized Quadruple-blind Treatment

B&O for TLH Post-operative Pain and Nausea

Hysterectomy · Pain, Postoperative

Source: ClinicalTrials.gov NCT03657407 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcomePrimary: Post-operative Pain: VAS — 4.1; 4.8 score on a scale — p=0.17

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.