Combined Anesthesia for Laparoscopy Surgery in Gynecology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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combined anesthesia

Patients will receive spinal and general anesthesia for benign laparoscopy gynecological surgery

Group Type ACTIVE_COMPARATOR

Spinal anesthesia with Fentanyl+ Morphine

Intervention Type PROCEDURE

Fentanyl 15 microgram Morphine 0.1-0.5 mg

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Spinal anesthesia with Fentanyl+ Morphine

Fentanyl 15 microgram Morphine 0.1-0.5 mg

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No