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

Phase 3
Completed
Conditions
Gynecological Laparoscopy
Interventions
Drug: 10 mLRopivacaine 1%
Drug: Water for injection
Drug: 10 mL Ropivacaine 1%
Registration Number
NCT00927979
Lead Sponsor
Carmel Medical Center
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 gynecologic laparoscopic surgery. This is a second steady with protocol of general anesthesia used of Remifentanil.

Detailed Description

Outcome Measures :

* VAS score

* Use of analgesics during operation and postoperative period

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
40
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ropivacaine10 mLRopivacaine 1%-
Ropivacaine10 mL Ropivacaine 1%-
Water for injectionWater for injection-
Primary Outcome Measures
NameTimeMethod
Visual Analog Score (VAS)24 hours
Secondary Outcome Measures
NameTimeMethod
Use of Analgesics24 hours
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