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

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

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.

Study Overview

• Status: Completed
• Conditions: Gynecological Laparoscopy
• Intervention / Treatment: Drug: 10 mLRopivacaine 1%; Drug: 10 mL Ropivacaine 1%; Drug: Water for injection

Detailed Description

Outcome Measures :

• VAS score
• Use of analgesics during operation and postoperative period

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Analog Score (VAS)	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Use of Analgesics	24 hours

Collaborators and Investigators

• Sponsor: Carmel Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: June 24, 2009
• First Submitted That Met QC Criteria: June 24, 2009
• First Posted (Estimate): June 25, 2009

Study Record Updates

• Last Update Posted (Estimate): June 28, 2011
• Last Update Submitted That Met QC Criteria: June 26, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: CMC090074CTIL; PSDR (Other Identifier: Gynecology Dept. Code)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No