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

Gynecological Laparoscopy Clinical Trial

— PSDR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927979
• Other study ID #: CMC090074CTIL
• Secondary ID: PSDR
• Status: Completed
• Phase: Phase 3
• First received: June 24, 2009
• Last updated: June 26, 2011
• Start date: June 2009
• Est. completion date: October 2010

Study information

• Verified date: June 2011
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Description:

Outcome Measures :

• VAS score

• Use of analgesics during operation and postoperative period

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gynecological Laparoscopy

Intervention

Drug:
• 10 mLRopivacaine 1%
Intraperitoneal nebulization of 10 mL Ropivacaine 1%
• Water for injection
Intraperitoneal nebulization of 10 mL water for injection
• 10 mL Ropivacaine 1%
Intraperitoneal nebulization of 10 mL Ropivacaine 1%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Score (VAS)		24 hours	No
Secondary	Use of Analgesics		24 hours	No