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Completed

NCT Number: NCT01150474

Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Phoenix, Arizona, 85054, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Belladonna and Opium Suppositories

Drug

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.

Other names: B & O Supprettes

Placebo Suppositories

Drug

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

Primary outcomes

  1. Pain at Hour 4

    Time frame: 4 hours following surgery

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

Secondary outcomes

  1. Pain at Hour 12

    Time frame: 12 hours after surgery.

    Pain at 12 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."

  2. Pain at Hour 20

    Time frame: 20 hours after surgery.

    Pain at 20 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."

  3. Narcotic Rescue Medication

    Time frame: For 24 hours following surgery

    Use of all ancillary narcotic medications was taken from the medical record.

  4. Number of Subjects With Nausea

    Time frame: Approximately 12 hours after surgery

    This information was taken from the medical record.

  5. Number of Subjects With Vomiting

    Time frame: Within 20 hours of surgery

    This information was taken from the medical record.

  6. Number of Times Antiemetic Rescue Medication Was Used

    Time frame: First 24 hours after surgery

  7. Number of Subjects Who Used Antiemetic Rescue Medications

    Time frame: First 24 hours after surgery

  8. Satisfaction With Pain Relief

    Time frame: Approximately 24 hours following surgery

    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."

Sponsors and collaborators

Lead sponsor

Kristina A. Butler

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 25, 2010
Registry last updated
Jan 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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