Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy

Phase 3

Completed

• Conditions: Laparoscopic Surgical Procedures
• Interventions: Device: Aeroneb Pro Nezulizer, Aerogen, Ireland; Drug: ropivacaine

• Registration Number: NCT00433316
• 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 gynecological laparoscopic surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-02
• Study Start: 2007-02
• Study First Submitted: 2007-02-08
• Study First Submitted QC: 2007-02-08
• Study First Posted: 2007-02-09
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Last Update Submitted: 2008-06-19
• Last Update Posted: 2008-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Aeroneb Pro Nezulizer, Aerogen, Ireland	Receiving 10ml of saline
study	ropivacaine	Receiving 10ml of 1% ropivacaine

Primary Outcome Measures

Name	Time	Method
VAS score	early post-operative

Trial Locations

Locations (1)

the Carmel Medical Center Ambulatory Gynecoendoscopic Unit; 🇮🇱 Haifa, Israel