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Clinical Trials/NCT00433316
NCT00433316
Completed
Phase 3

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

Carmel Medical Center1 site in 1 country40 target enrollmentFebruary 2007

Overview

Phase
Phase 3
Intervention
ropivacaine
Conditions
Laparoscopic Surgical Procedures
Sponsor
Carmel Medical Center
Enrollment
40
Locations
1
Primary Endpoint
VAS score
Status
Completed
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2007
End Date
October 2007
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Carmel Medical Center

Eligibility 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-
  • Age \< 18 years.
  • Significant arrythmias
  • Analgesic treatment for chronic pain

Arms & Interventions

study

Receiving 10ml of 1% ropivacaine

Intervention: ropivacaine

Control

Receiving 10ml of saline

Intervention: Aeroneb Pro Nezulizer, Aerogen, Ireland

Outcomes

Primary Outcomes

VAS score

Time Frame: early post-operative

Study Sites (1)

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