Local Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind Study

Hvidovre University Hospital48 enrolled

Overview

The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % vs. Placebo in patients undergoing vaginal hysterectomy. The hypothesis is that systematic local infiltration will reduce postoperative pain and postoperative opioid consumption.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Pain, Postoperative Postoperative Nausea and Vomiting

Interventions

Ropivacaine 0.5 %DRUG

Local Infiltration with Ropivacaine 0.5 %

Isotonic NaClDRUG

Local Infiltration with NaCl

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * eligible for elective vaginal hysterectomy * 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

Time frame: 32 h

Secondary Outcomes

PONV

Time frame: 32 h

Data from ClinicalTrials.gov

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