N/A N=46 Randomized Triple-blind Treatment

Reducing Post-Op Pain After Sacrospinous Ligament Colpopexy

Pain

Bottom Line

View on ClinicalTrials.gov: NCT02037061 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Postoperative Gluteal Pain — 3.6; 4.0; 2.0; 2.0 units on a scale — p=0.83

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Bupivacaine (Drug); Normal Saline (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: The Cleveland Clinic
Primary completion: Jul 2016

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	—

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.

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)

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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.