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

This study has been completed.
Sponsor:
Information provided by:
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT00927979
First received: June 24, 2009
Last updated: June 26, 2011
Last verified: June 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of Analgesics [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ostrovsky Ludmila, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT00927979     History of Changes
Other Study ID Numbers: CMC090074CTIL, PSDR
Study First Received: June 24, 2009
Last Updated: June 26, 2011
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on July 22, 2014