Text Size

Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy

This study has been completed.
Sponsor:
Information provided by:
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT00433316
First received: February 8, 2007
Last updated: June 19, 2008
Last verified: February 2007
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pain Relief by Continuous Intra-Peritoneal Nebulization of Ropivacaine During Gynecological Laparoscopic Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • VAS score [ Time Frame: early post-operative ] [ Designated as safety issue: No ]

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
Other Name: Aeroneb Pro Nezulizer, Aerogen, Ireland

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433316

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

No publications provided

Responsible Party: Yuval Kaufman, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT00433316     History of Changes
Other Study ID Numbers: CMC064113CTIL, HT 3758
Study First Received: February 8, 2007
Last Updated: June 19, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Carmel Medical Center:
ropivacaine
laparoscopy
intraperitoneal
nebulization
 pain
local analgesic
gynecology

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013