NCT03332056

Brief Summary

The purpose of this study is to determine if preemptive B\&O suppository placement will decrease post-operative pain in patients undergoing ureteral stent placement.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2013

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
2 years until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

June 18, 2023

Completed
Last Updated

June 18, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

November 4, 2015

Results QC Date

March 19, 2023

Last Update Submit

May 24, 2023

Conditions

Nephrolithiasis

Keywords

Ureteral stent painnephrolithiasiskidney stone

Outcome Measures

Primary Outcomes (2)

  • Global Quality of Life Score on Postoperative Day 1

    Global quality of life score as measured by the Ureteral Stent Symptom Questionnaire (USSQ). Scale is 1-7 (Lower score indicating better quality of life compared to higher score). 1 = delighted, 2 = pleased, 3 = mostly satisfied, 4 = mixed feelings (about equally satisfied and dissatisfied), 5 = mostly dissatisfied, 6 = unhappy, 7 = terrible

    postoperative day 1

  • Global Quality of Life Score on Postoperative 3

    Global quality of life score as measured by the Ureteral Stent Symptom Questionnaire (USSQ). Scale is 1-7 (Lower score indicating better quality of life compared to higher score). 1 = delighted, 2 = pleased, 3 = mostly satisfied, 4 = mixed feelings (about equally satisfied and dissatisfied), 5 = mostly dissatisfied, 6 = unhappy, 7 = terrible

    postoperative day 3

Secondary Outcomes (3)

  • Number of Participants With Postoperative Complications as a Result of the Use of B&O Suppository

    14 days post-op

  • Number of Participants With Unanticipated Postoperative Visits

    14 days post-op

  • Measurement of Post-operative Narcotic Use

    14 days post-op

Study Arms (2)

Belladonna and Opium (B&O) suppository

ACTIVE COMPARATOR

A single belladonna and opium suppository, dose-weight calculated, administered immediately following patient positioning prior to instrumentation. The pharmacologically active ingredients that are present in the belladonna extract consist of atropine and scopolamine. Opium is compound drug that is composed of 20 alkaloids. The principle alkaloid that derives the majority of its effect is its morphine content and acts as a narcotic analgesic by increasing the pain threshold or the magnitude of stimulus required to evoke pain.

Drug: Belladonna and Opium

Placebo Suppository

PLACEBO COMPARATOR

placebo suppository

Other: Placebo suppository

Interventions

Belladonna and OpiumDRUG
Also known as: B&O
Belladonna and Opium (B&O) suppository
Placebo suppositoryOTHER
Placebo Suppository

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who will receive ureteroscopy with concurrent placement of a ureteral stent.

You may not qualify if:

  • age \< 18,
  • neurologic deficits of any kind
  • non-English speaking patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NephrolithiasisKidney Calculi

Interventions

Opium

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Results Point of Contact

Title
Jonathan Harper
Organization
University of Washington
jdharper@uw.edu
2065988279

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 6, 2017

Study Start

August 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2015

Last Updated

June 18, 2023

Results First Posted

June 18, 2023

Record last verified: 2023-05