Combined Anesthesia for Laparoscopy Surgery in Gynecology

Not Applicable

• Conditions: Pain
• Interventions: Procedure: Spinal anesthesia with Fentanyl+ Morphine

• Registration Number: NCT01246323
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

The purpose of this study is to determine whether combined anesthesia will provide better pain control for the postoperative period following gynecological laparoscopy surgery.

Detailed Description

Following signing an informed consent patients who are scheduled for gynecological laparoscopy surgery for benign disease will randomized to general vs. combined general and spinal anesthesia.

During the postoperative period data regarding pain level as evaluated by visual analogue scale (VAS), number of doses of pain relief drugs, satisfaction and number of day in hospitalization will be collected from patient charts.

Study Timeline

• Status Verified: 2010-11
• Study Start: 2010-11
• Study First Submitted: 2010-11-14
• Study First Submitted QC: 2010-11-21
• Study First Posted: 2010-11-23
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-05
• Primary Completion: 2012-11
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. American Society of Anesthesiology (ASA) physical status classification system:ASA I-III.
2. Benign Gynecological Laparoscopy surgery

Exclusion Criteria

1. Patients who are not capable to sign the consent form.
2. Women with known allergy to the medication used in spinal analgesia.
3. Patients who are pregnant or lactating.
4. Patients with contraindication to spinal analgesia.
5. Patients who use opioid on a regular base.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combined anesthesia	Spinal anesthesia with Fentanyl+ Morphine	Patients will receive spinal and general anesthesia for benign laparoscopy gynecological surgery

Primary Outcome Measures

Name	Time	Method
Pain level	For the first 72 hours following surgery	Pain level will be evaluated every 4 hours from the time of surgery to discharge
Number of doses of analgesic drugs	For the first 72 hours following surgery	Number of doses of analgesic medications will be collected from patients charts.

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel