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

Israel Healthcare Foundation

Status and phase: Completed; Phase 3

Conditions: Gynecological Laparoscopy

Treatments: Drug: 10 mL Ropivacaine 1%; Drug: Water for injection; Drug: 10 mLRopivacaine 1%

Study type: Interventional

Funder types: Other

Identifiers

NCT00927979

PSDR (Other Identifier)

CMC090074CTIL

Details and patient eligibility

About

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.

Full description

Outcome Measures :

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

Enrollment: 40 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Ropivacaine

Experimental group

Treatment:

Drug: 10 mLRopivacaine 1%

Drug: 10 mL Ropivacaine 1%

Water for injection

Placebo Comparator group

Treatment:

Drug: Water for injection