Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery

Kristina A. Butler

Status and phase: Completed; Phase 4

Conditions: Vaginal Surgery

Treatments: Drug: Placebo Suppositories; Drug: Belladonna and Opium Suppositories

Study type: Interventional

Funder types: Other

Identifiers

NCT01150474

09-008045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 2 patient groups, including a placebo group

Belladonna and Opium Suppositories

Experimental group

Description:

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.

Treatment:

Drug: Belladonna and Opium Suppositories

Placebo Suppositories

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Suppositories