Phase 4
Completed N=103
Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery
Vaginal Surgery
Source: ClinicalTrials.gov NCT01150474 ↗
Enrolled (actual)
103
Serious AEs
1.1%
Results posted
Jan 2015
Primary outcomePrimary: Pain at Hour 4 — 4.2; 4.1 units on a scale — p=0.82
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain at Hour 4 |
4.2; 4.1 | 0.82 |
| SECONDARY Pain at Hour 12 |
3.4; 3.3 | 0.75 |
| SECONDARY Pain at Hour 20 |
2.5; 3.4 | 0.07 |
| SECONDARY Narcotic Rescue Medication |
57; 66 | 0.43 |
| SECONDARY Number of Subjects With Nausea |
14; 22 | 0.30 |
| SECONDARY Number of Subjects With Vomiting |
13; 9 | 0.14 |
| SECONDARY Number of Times Antiemetic Rescue Medication Was Used |
1.7; 1.6 | 0.83 |
| SECONDARY Number of Subjects Who Used Antiemetic Rescue Medications |
30; 33 | 0.55 |
| SECONDARY Satisfaction With Pain Relief |
8.2; 7.9 | 0.59 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01150474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.