Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy

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: NCT00433316
Recruitment Status : Completed
First Posted : February 9, 2007
Last Update Posted : June 20, 2008
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 gynecological laparoscopic surgery.

Condition or disease Intervention/treatment Phase
Laparoscopic Surgical Procedures Drug: ropivacaine Device: Aeroneb Pro Nezulizer, Aerogen, Ireland Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pain Relief by Continuous Intra-Peritoneal Nebulization of Ropivacaine During Gynecological Laparoscopic Surgery
Study Start Date : February 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: study
Receiving 10ml of 1% ropivacaine
Drug: ropivacaine
1% ropivacaine
Other Name: Narop
Placebo Comparator: Control
Receiving 10ml of saline
Device: Aeroneb Pro Nezulizer, Aerogen, Ireland
Aeroneb Pro Nezulizer, Aerogen, Ireland

Primary Outcome Measures :
  1. VAS score [ Time Frame: early post-operative ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Elective gynecologic laparoscopic surgery including unilateral or bilateral salpingo-oopherectomy or ovarian cystectomy.
  • The patient is not participating in other medical study at present or in the last 30 days.
  • The patient signed on an informed consent.
  • Age 18 years and above.
  • ASA (American Society of Anesthesiologists) physical status grade 1- 2.

Exclusion Criteria:

  • Allergy to Ropivacaine, other local anesthetics or other medications listed in the protocol.
  • The patient is participating in other medical experiment at present or in the last 30 days.
  • Acute Pelvic Inflammatory Disease.
  • Coumadin or Aspirin treatment.
  • ASA physical status grade 3-4.
  • Age < 18 years.
  • Significant arrythmias
  • Analgesic treatment for chronic pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00433316

the Carmel Medical Center Ambulatory Gynecoendoscopic Unit
Haifa, Israel, 34362
Sponsors and Collaborators
Carmel Medical Center
Principal Investigator: Yuval Kaufman, MD Carmel Medical Center, Haifa, Israel
Study Director: Reuven Pizov, Prof. Carmel Medical Center, Haifa, Israel

Responsible Party: Yuval Kaufman, Carmel Medical Center Identifier: NCT00433316     History of Changes
Other Study ID Numbers: CMC064113CTIL
HT 3758
First Posted: February 9, 2007    Key Record Dates
Last Update Posted: June 20, 2008
Last Verified: February 2007

Keywords provided by Carmel Medical Center:
local analgesic

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents