Trial intelligence / Profile preview

Local Infiltration Analgesia with Ropivacaine in Caesarean Section

NCT00891540Phase 4

Key facts

Status
Completed
Start
Jul 2009
Primary completion
May 2010
Countries
1
Sponsor
Copenhagen University Hospital - Hvidovre
Modality
Orthosteric Ligands
Conditions
postoperative pain
01

Overview

Phase 4, randomised, double-blind trial of ropivacaine in postoperative pain (3 arms), sponsored by Copenhagen University Hospital - Hvidovre. Primary endpoint: Postoperative pain at 24 hours. Started Jul 2009; status: completed.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • Ropivacaine 0.5%

    Local infiltration with Ropivacaine 0.5%

  • Ropivacaine 0.2%

    Local infiltration with Ropivacaine 0.2%

  • Placebo

    Local infiltration with Isotonic NaCl

03

Who it enrols

Patients eligible for elective caesarean section, able to speak Danish and give informed consent. Excludes patients with alcohol/medical abuse, allergies to local anesthetics, or intolerance to opioids.

04

Endpoints

Primary

  • Postoperative pain

Secondary

  • Postoperative nausea and vomiting

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