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The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation

NCT03995641 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-02-05

No results posted yet for this study

Summary

This study will randomize patients to either receive intraoperative administration of local anesthetic and corticosteriod at time of sacrospinous ligament fixation compared to placebo to determine if intraoperative trigger point injection (TPI) improves postoperative gluteal and sciatic pain scores along with use of narcotic pain medications.

There is a paucity of data examining interventions to potentially ameliorate the postoperative gluteal pain often associated with sacrospinous ligament colpopexy. Our study aims to determine if a compounded TPI improves postoperative pain scores and minimizes use of narcotic pain medications by 20% compared to controls.

Conditions

  • Postoperative Pain
  • Pelvic Organ Prolapse
  • Trigger Point Injection
  • Sacrospinous Ligament Fixation

Interventions

DRUG

marcaine and kenalog

Trigger point injection (consisting of 9 cc 0.5% Marcaine and 1 cc kenalog) may be given at time of surgery if patient is randomized to receive the injection

Sponsors & Collaborators

  • Kettering Health Network

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-02
Primary Completion
2023-09-12
Completion
2023-09-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03995641 on ClinicalTrials.gov