Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery

Vaginal Surgery Clinical Trial

Official title:

Randomized Clinical Trial of Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150474
• Other study ID #: 09-008045
• Status: Completed
• Phase: Phase 4
• First received: June 23, 2010
• Last updated: December 23, 2014
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Minimizing postoperative pain is vital to a successful surgical recovery. Inadequate pain control may result in nausea, vomiting, an extended hospital stay, and reduced patient satisfaction. Oral and parenteral narcotics are commonly used for pain relief and their use may exacerbate the incidence of sedation, nausea, and vomiting; ultimately delaying convalescence. Previous studies have demonstrated that rectal analgesia following surgery results in lower pain scores and less intravenous morphine consumption. Belladonna and opium suppositories are routinely prescribed at our institution and their efficacy has not been confirmed.

A prospective, randomized, double-blind, placebo-controlled trial will be undertaken using belladonna and opium rectal suppositories following vaginal surgery. Treatment will begin immediately following surgery and continue every 8 hours for a total of 3 doses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vaginal Surgery

Intervention

Drug:
• Belladonna and Opium Suppositories
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.
• Placebo Suppositories
Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.

Locations

Country	Name	City	State
United States	Mayo Clinic	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Kristina A. Butler

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain at Hour 12	Pain at 12 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."	12 hours after surgery.	No
Secondary	Pain at Hour 20	Pain at 20 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."	20 hours after surgery.	No
Secondary	Narcotic Rescue Medication	Use of all ancillary narcotic medications was taken from the medical record.	For 24 hours following surgery	No
Secondary	Number of Subjects With Nausea	This information was taken from the medical record.	Approximately 12 hours after surgery	No
Secondary	Number of Subjects With Vomiting	This information was taken from the medical record.	Within 20 hours of surgery	No
Secondary	Number of Times Antiemetic Rescue Medication Was Used		First 24 hours after surgery	No
Secondary	Number of Subjects Who Used Antiemetic Rescue Medications		First 24 hours after surgery	No
Secondary	Satisfaction With Pain Relief	Patient satisfaction with pain relief was evaluated 24 hours after surgery using a linear analog satisfaction scale, with 0 being "very dissatisfied," and 10 being "very satisfied."	Approximately 24 hours following surgery	No