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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 25, 2009
Last Update Posted: June 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Carmel Medical Center
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.

Condition Intervention Phase
Gynecological Laparoscopy Drug: 10 mLRopivacaine 1% Drug: Water for injection Drug: 10 mL Ropivacaine 1% Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Visual Analog Score (VAS) [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Use of Analgesics [ Time Frame: 24 hours ]

Enrollment: 40
Study Start Date: June 2009
Study Completion Date: October 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ropivacaine Drug: 10 mLRopivacaine 1%
Intraperitoneal nebulization of 10 mL Ropivacaine 1%
Drug: 10 mL Ropivacaine 1%
Intraperitoneal nebulization of 10 mL Ropivacaine 1%
Placebo Comparator: Water for injection Drug: Water for injection
Intraperitoneal nebulization of 10 mL water for injection

Detailed Description:

Outcome Measures :

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Ostrovsky Ludmila, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT00927979     History of Changes
Other Study ID Numbers: CMC090074CTIL
PSDR ( Other Identifier: Gynecology Dept. Code )
First Submitted: June 24, 2009
First Posted: June 25, 2009
Last Update Posted: June 28, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General