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Effect of Preemptive Pudendal Nerve Block Using Bupivacaine Versus Ropivacaine on Post-operative Pain After Posterior Vaginal Repair.

NCT03939910 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2019-05-07

No results posted yet for this study

Summary

To investigate the efficacy of preemptive pudendal nerve blockade on postoperative pain, after posterior vaginal repair, below the level of ischial spine, excluding uterine suspension procedures that are higher than the coverage of the block.

Primary outcome:

The primary outcome measures of the study visual analogue pain scores and postoperative analgesic consumption.

Conditions

  • Post-operative Pain After Posterior Vaginal Repair

Interventions

DEVICE

Pudendal Nerve Block needle in pre-packaged kits that include both the trumpet and the needle. The needle will limits its depth of penetration to 5 mm beyond the trumpet.

Patients will receive a pudendal nerve block injection on each side as previously described 5-10 minutes before the beginning of surgery. A tubular director that allows 1.0-1.5 cm of a 15-cm-long, 22-gauge needle to protrude beyond its tip will be used to guide the needle into the pudendal trunk at lesser sciatic foramen about 1 cm inferior-medial to attachment of the sacrospinous ligament to the ischial spine. The end of the director will be placed against the vaginal epithelium just beneath the tip of the ischial spine. The needle pushed beyond the tip of the director, and 5 ml of the anaesthetic solution will be injected. The needle advanced 1 cm posterior and lateral, and another 5 mL of the anaesthetic solution will be injected into this region.

Sponsors & Collaborators

  • Munazzah Rafique

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2020-12-30
Completion
2021-06-30

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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 NCT03939910 on ClinicalTrials.gov