Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy

Laparoscopic Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433316
• Other study ID #: CMC064113CTIL
• Secondary ID: HT 3758
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2007
• Last updated: June 19, 2008
• Start date: February 2007
• Est. completion date: October 2007

Study information

• Verified date: February 2007
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• 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 gynecological laparoscopic surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 3-4.

• Age < 18 years.

• Significant arrythmias

• Analgesic treatment for chronic pain

Study Design

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

Related Conditions & MeSH terms

• Laparoscopic Surgical Procedures

Intervention

Drug:
• ropivacaine
1% ropivacaine

Device:
• Aeroneb Pro Nezulizer, Aerogen, Ireland
Aeroneb Pro Nezulizer, Aerogen, Ireland

Locations

Country	Name	City	State
Israel	the Carmel Medical Center Ambulatory Gynecoendoscopic Unit	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS score		early post-operative	No