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Completed

NCT Number: NCT00927979

Pain Relief by Intra-Peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia for Gynecological Laparoscopy

In our prospective, randomized, placebo controlled and double-blinded study we will study the efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecologic laparoscopic surgery. This is a second steady with protocol of general anesthesia used of Remifentanil.

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Key information

Conditions

Gynecological Laparoscopy

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

Outcome Measures :

  • VAS score
  • Use of analgesics during operation and postoperative period

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Elective gynecological laparoscopic surgery including unilateral or bilateral salpingo-oophorectomy or ovarian cystectomy
  • Patient not participating in other medical study at present or during the last 30 days
  • Patient is capable of reading, understanding and signing on an informed consent
  • Age 18 years and above
  • ASA physical status grade 1-2

Exclusion criteria

  • Allergy to ropivacaine or other local anesthetics or other medications listed in the protocol
  • Acute pelvic inflammatory disease
  • Coumadin or aspirin treatment
  • Significant arrythmias
  • Analgesic treatment for chronic pain
  • BMI>35

Treatment and study plan

10 mLRopivacaine 1%

Drug

Intraperitoneal nebulization of 10 mL Ropivacaine 1%

Water for injection

Drug

Intraperitoneal nebulization of 10 mL water for injection

10 mL Ropivacaine 1%

Drug

Intraperitoneal nebulization of 10 mL Ropivacaine 1%

Primary outcomes

  1. Visual Analog Score (VAS)

    Time frame: 24 hours

Secondary outcomes

  1. Use of Analgesics

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Carmel Medical Center

Other

Registry information

Official study title

Phase 3 Prospective, Randomized, Controlled and Double-blinded Second Trial on Pain Relief by Continuous Intra-peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia, During Gynecological Laparoscopic Surgery

Acronym: PSDR

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 25, 2009
Registry last updated
Jun 28, 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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