Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse:a Randomized, Double-Blind Study

Hvidovre University Hospital48 enrolled

Overview

The purpose of this study is to compare systematic local infiltration with ropivacaine or placebo in patients undergoing repair of posterior vaginal wall prolapse. The hypothesis is that LIA technique is opioid-sparing and a better postoperative treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Vaginal Prolapse

Interventions

RopivacaineDRUG

Local Infiltration Analgesia with 1 % Ropivacaine

Isotonic NaClDRUG

Local Infiltration with NaCl

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * eligible for elective repair of posterior vaginal wall prolapse * able to speak and understand Danish * able to give informed consent Exclusion Criteria: * alcohol or medical abuse * allergies to local anesthetics * age \< 18 yrs. * intolerance to opioids

Locations (1)

Hvidovre University Hospital

Copenhagen, Hvidovre, Denmark

Outcomes

Primary Outcomes

Postoperative Pain during rest, coughing and ambulation

Time frame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively

Secondary Outcomes

Postoperative Nausea and Vomitus

Time frame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively

Data from ClinicalTrials.gov

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