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
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
Drug: Belladonna Opium
Drug: Glycerin Suppository
|Recruitment Details||A cohort of 281 women was assessed for trial eligibility. Patients were excluded from enrollment if the patient could not be reached pre-operatively (n=47), if inclusion criteria were not met (n=67), or if participation was declined (n=106). A cohort of 61 women met criteria for trial enrollment.|
|Pre-assignment Details||From a cohort of 61 women meeting criteria for trial enrollment, individuals were excluded from study participation and randomization if the study protocol was not executed by the surgical team i.e. study medication was not ordered/administrated (n=5). 56 women underwent randomization/assignment to the study interventions.|
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.