NCT00433316
Completed
Phase 3
Pain Relief by Continuous Intra-Peritoneal Nebulization of Ropivacaine During Gynecological Laparoscopic Surgery
Carmel Medical Center1 site in 1 country40 target enrollmentFebruary 2007
ConditionsLaparoscopic Surgical Procedures
Drugsropivacaine
Overview
- Phase
- Phase 3
- Intervention
- ropivacaine
- Conditions
- Laparoscopic Surgical Procedures
- Sponsor
- Carmel Medical Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- VAS score
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility Criteria
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-
- •Age \< 18 years.
- •Significant arrythmias
- •Analgesic treatment for chronic pain
Arms & Interventions
study
Receiving 10ml of 1% ropivacaine
Intervention: ropivacaine
Control
Receiving 10ml of saline
Intervention: Aeroneb Pro Nezulizer, Aerogen, Ireland
Outcomes
Primary Outcomes
VAS score
Time Frame: early post-operative
Study Sites (1)
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