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

Carmel Medical Center40 enrolled

Overview

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.

Outcome Measures : * VAS score * Use of analgesics during operation and postoperative period

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gynecological Laparoscopy

Interventions

10 mLRopivacaine 1%DRUG

Intraperitoneal nebulization of 10 mL Ropivacaine 1%

Water for injectionDRUG

Intraperitoneal nebulization of 10 mL water for injection

10 mL Ropivacaine 1%DRUG

Intraperitoneal nebulization of 10 mL Ropivacaine 1%

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Visual Analog Score (VAS)

Time frame: 24 hours

Secondary Outcomes

Use of Analgesics

Time frame: 24 hours

Data from ClinicalTrials.gov

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