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OpenTrials
Completed

NCT Number: NCT00768456

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

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.

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Key information

Conditions

Pain, Postoperative 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 and older

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 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

Treatment and study plan

Ropivacaine 0.5 %

Drug

Local Infiltration with Ropivacaine 0.5 %

Isotonic NaCl

Drug

Local Infiltration with NaCl

Primary outcomes

  1. Postoperative pain

    Time frame: 32 h

Secondary outcomes

  1. PONV

    Time frame: 32 h

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo VED Vaginal Hysterektomi: ET Prospektivt Randomiseret, Dobbeltblind ET, Placebo-kontrolleret Studie

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 8, 2008
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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