NCT01150474

Brief Summary

Our primary aim is to determine whether the routine use of belladonna and morphine suppositories will improve pain control following vaginal surgery. Treatment will begin immediately following surgery and every 8 hours for 16 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 7, 2015

Completed
Last Updated

January 7, 2015

Status Verified

December 1, 2014

Enrollment Period

2.9 years

First QC Date

June 23, 2010

Results QC Date

December 23, 2014

Last Update Submit

December 23, 2014

Conditions

Vaginal Surgery

Keywords

BelladonnaMorphineSuppositoriesVaginalSurgeryPostoperativePain

Outcome Measures

Primary Outcomes (1)

  • Pain at Hour 4

    Pain at 4 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."

    4 hours following surgery

Secondary Outcomes (8)

  • Pain at Hour 12

    12 hours after surgery.

  • Pain at Hour 20

    20 hours after surgery.

  • Narcotic Rescue Medication

    For 24 hours following surgery

  • Number of Subjects With Nausea

    Approximately 12 hours after surgery

  • Number of Subjects With Vomiting

    Within 20 hours of surgery

  • +3 more secondary outcomes

Study Arms (2)

Belladonna and Opium Suppositories

EXPERIMENTAL

Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.

Drug: Belladonna and Opium Suppositories

Placebo Suppositories

PLACEBO COMPARATOR

Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.

Drug: Placebo Suppositories

Interventions

Belladonna and Opium SuppositoriesDRUG

Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.

Also known as: B & O Supprettes
Belladonna and Opium Suppositories
Placebo SuppositoriesDRUG

Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.

Placebo Suppositories

Eligibility Criteria

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

You may qualify if:

  • Scheduled for elective vaginal surgery requiring general anesthesia at the Mayo Clinic Hospital. This would include a vaginal hysterectomy with culdoplasty or post-hysterectomy prolapse repair, including culdoplasty with or without anterior/posterior repair.

You may not qualify if:

  • Participation in another trial using an investigational product.
  • Pregnancy.
  • Scheduled for a non-vaginal surgical procedure.
  • Scheduled for a robotic hysterectomy.
  • Scheduled to have combined surgeries (vaginal surgery plus another non-vaginal surgery).
  • There is a known hypersensitivity to belladonna and/or opium.
  • Contraindication to narcotic use.
  • Chronic pain with preoperative pain score greater than 4 out of 10 points.
  • Clinically significant substance abuse.
  • Mental condition that may impair the ability to provide study assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Kristina A. Butler
Organization
Mayo Clinic
butler.kristina@mayo.edu
480-301-5934

Study Officials

  • Kristina Butler, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 23, 2010

First Posted

June 25, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 7, 2015

Results First Posted

January 7, 2015

Record last verified: 2014-12

Locations

US(1)