N/A
Completed N=46
Reducing Post-Op Pain After Sacrospinous Ligament Colpopexy
Source: ClinicalTrials.gov NCT02037061 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Postoperative Gluteal Pain — 3.6; 4.0; 2.0; 2.0 units on a scale — p=0.83
Summary
This is a randomized controlled trial to determine if intraoperative local analgesia administered at the level of the sacrospinous ligament can lessen the gluteal pain felt by patients postoperatively after SSL colpopexy.
Hypothesis: Local analgesia administered at the level of the sacrospinous ligament can lessen the gluteal pain felt by patients postoperatively after SSL colpopexy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Gluteal Pain |
3.6; 4.0; 2.0; 2.0; 1.1; 1.0 | 0.83 |
| SECONDARY Need for Intervention for Postoperative Pain |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Overall Pain Beyond Day of Discharge |
1.1; 1.0; 0.3; 0.3; 0.1; 0.1 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18, who are to undergo sacrospinous ligament colpopexy for vaginal apex prolapse after hysterectomy
- Other concomitant prolapse and anti-incontinence procedures (e.g., anterior colporrhaphy, paravaginal defect repair, posterior colporrhaphy, or mid-urethral sling procedures) will be performed at the primary surgeon's discretion
Exclusion Criteria
- Inability to comprehend written and/or spoken English
- Inability to provide informed consent
- Need for concomitant surgeries not related to pelvic organ prolapse or incontinence
- Chronic pain conditions (e.g., fibromyalgia, myositis, myofascial pain syndrome)
Data sourced from ClinicalTrials.gov (NCT02037061). 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.