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

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. Identifier: NCT00927979
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : June 28, 2011
Information provided by:
Carmel Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Gynecological Laparoscopy Drug: 10 mLRopivacaine 1% Drug: Water for injection Drug: 10 mL Ropivacaine 1% Phase 3

Detailed Description:

Outcome Measures :

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : June 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

Responsible Party: Ostrovsky Ludmila, Carmel Medical Center Identifier: NCT00927979     History of Changes
Other Study ID Numbers: CMC090074CTIL
PSDR ( Other Identifier: Gynecology Dept. Code )
First Posted: June 25, 2009    Key Record Dates
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