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Combined Anesthesia for Laparoscopy Surgery in Gynecology

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ClinicalTrials.gov Identifier: NCT01246323
Recruitment Status : Unknown
Verified November 2010 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : November 23, 2010
Last Update Posted : August 5, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Pain Procedure: Spinal anesthesia with Fentanyl+ Morphine

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Combined General and Spinal Anesthesia vs. General Anesthesia for Pain Relief During Laparoscopy Gynecological Surgery
Study Start Date : November 2010
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
Drug Information available for: Fentanyl
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: combined anesthesia
Patients will receive spinal and general anesthesia for benign laparoscopy gynecological surgery
Procedure: Spinal anesthesia with Fentanyl+ Morphine
Fentanyl 15 microgram Morphine 0.1-0.5 mg
No Intervention: Control


Outcome Measures

Primary Outcome Measures :
  1. Pain level [ Time Frame: For the first 72 hours following surgery ]
    Pain level will be evaluated every 4 hours from the time of surgery to discharge

  2. Number of doses of analgesic drugs [ Time Frame: For the first 72 hours following surgery ]
    Number of doses of analgesic medications will be collected from patients charts.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246323


Contacts
Contact: Lior Lowenstein, MD, MS 050-2061434 LowensteinMD@gmail.com

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Contact: Lior Lowenstein, MD    97248542612 ext 7    l_lior@rambam.health.gov.il   
Contact: Dror Segal, MD    97248542382    d_segal@rambam.health.gov.il   
Rambam Health Care Campus Not yet recruiting
Haifa, Israel, 9602
Contact: Lior Lowenstein, MD, MS    050-2061434    LowensteinmD@gmail.com   
Principal Investigator: Lior Lowenstein, MD,MS         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Study Chair: Lior Lowenstein Rambam Health Care Campus
More Information

Publications:
Responsible Party: Lior Lowenstein, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01246323     History of Changes
Other Study ID Numbers: COBINED ANASTHESIA GYNECOLOGY
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: November 2010

Keywords provided by Rambam Health Care Campus:
Visual analogue scale
pain level
analgesia
combined anesthesia

Additional relevant MeSH terms:
Anesthetics
Fentanyl
Morphine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General