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Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy

This study has been completed.
Information provided by:
Carmel Medical Center Identifier:
First received: February 8, 2007
Last updated: June 19, 2008
Last verified: February 2007
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 Intervention Phase
Laparoscopic Surgical Procedures
Drug: ropivacaine
Device: Aeroneb Pro Nezulizer, Aerogen, Ireland
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pain Relief by Continuous Intra-Peritoneal Nebulization of Ropivacaine During Gynecological Laparoscopic Surgery

Resource links provided by NLM:

Further study details as provided by Carmel Medical Center:

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

Enrollment: 40
Study Start Date: February 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Yuval Kaufman, Carmel Medical Center Identifier: NCT00433316     History of Changes
Other Study ID Numbers: CMC064113CTIL
HT 3758
Study First Received: February 8, 2007
Last Updated: June 19, 2008

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 processed this record on May 22, 2017