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Completed

NCT Number: NCT00891540

Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % versus Ropivacaine 0.2 % versus Placebo in patients undergoing elective caesarean section.

The hypothesis is that systemic local infiltration will reduce pain and postoperative opioid consumption.

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Key information

Conditions

Pain, Postoperative Cesarean Section Nausea Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • eligible for elective caesarean section
  • able to speak and understand Danish
  • able to give informed consent

Exclusion criteria

  • alcohol or medical abuse
  • allergies to local anesthetics
  • age < 18 years
  • intolerance to opioids

Treatment and study plan

Ropivacaine

Drug

Ropivacaine 0.5%

Placebo

Drug

Isotonic NaCl

Primary outcomes

  1. Postoperative pain

    Time frame: 24 hours

Secondary outcomes

  1. Postoperative nausea and vomiting (PONV)

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Ropivakain 0,2 % Versus Placebo Efter Sectio Caesarea: et Prospektivt, Dobbeltblindet, Placebokontrolleret Studie.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 1, 2009
Registry last updated
Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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