Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy

June 19, 2008 updated by: Carmel Medical Center

Pain Relief by Continuous Intra-Peritoneal Nebulization of Ropivacaine During Gynecological Laparoscopic Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 34362
        • the Carmel Medical Center Ambulatory Gynecoendoscopic Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study
Receiving 10ml of 1% ropivacaine
Drug: ropivacaine
1% ropivacaine
Other Names:
  • Narop
Placebo Comparator: Control
Receiving 10ml of saline
Device: Aeroneb Pro Nezulizer, Aerogen, Ireland
Aeroneb Pro Nezulizer, Aerogen, Ireland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS score
Time Frame: early post-operative
early post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Investigators

  • Principal Investigator: Yuval Kaufman, MD, Carmel Medical Center, Haifa, Israel
  • Study Director: Reuven Pizov, Prof., Carmel Medical Center, Haifa, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 8, 2007

First Submitted That Met QC Criteria

February 8, 2007

First Posted (Estimate)

February 9, 2007

Study Record Updates

Last Update Posted (Estimate)

June 20, 2008

Last Update Submitted That Met QC Criteria

June 19, 2008

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC064113CTIL
  • HT 3758

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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