Reducing Post-Op Pain After Sacrospinous Ligament Colpopexy

NCT02037061 | Completed Results

• 1 other identifier: 13-1413
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Gluteal Pain

  Pain measured using a pain numeric rating scale from 0 to 10 (0=no pain, 10= worst pain imaginable)

  6-weeks

Secondary Outcomes (2)

• Need for Intervention for Postoperative Pain

  6-weeks

• Overall Pain Beyond Day of Discharge

  6 weeks

Study Arms (2)

normal saline

PLACEBO COMPARATOR

Intraoperatively the patient will receive 10ml of normal saline injected into the sacrospinous ligament.

Other: Normal Saline

bupivacaine

ACTIVE COMPARATOR

Intraoperatively the patient will receive 10 ml of bupivacaine injected into the sacrospinous ligament.

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

Intraoperatively the patient will receive 10ml of bupivacaine injected into the sacrospinous ligament.

bupivacaine

Normal Saline OTHER

normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Ferrando CA, Walters MD. A randomized double-blind placebo-controlled trial on the effect of local analgesia on postoperative gluteal pain in patients undergoing sacrospinous ligament colpopexy. Am J Obstet Gynecol. 2018 Jun;218(6):599.e1-599.e8. doi: 10.1016/j.ajog.2018.03.033. Epub 2018 Mar 31.

  PMID: 29614274 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Cecile Unger
• Organization: Cleveland Clinic

ungerc@ccf.org

216-444-0542

Study Officials

• Cecile Unger, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 15, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 14, 2019
• Results First Posted: August 14, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)