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Completed

NCT Number: NCT00769054

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

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.

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Key information

Conditions

Vaginal Prolapse Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Postoperative Complications Postoperative Nausea and Vomiting Prolapse Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Uterine Diseases Uterine Prolapse 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 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

Treatment and study plan

Ropivacaine

Drug

Local Infiltration Analgesia with 1 % Ropivacaine

Isotonic NaCl

Drug

Local Infiltration with NaCl

Primary outcomes

  1. Postoperative Pain during rest, coughing and ambulation

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

Secondary outcomes

  1. Postoperative Nausea and Vomitus

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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Lokal Infiltrations Analgesi Med Ropivakain 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, Placebo- Kontrolleret Studie

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 8, 2008
Registry last updated
Jul 9, 2010

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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