We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combined Anesthesia for Laparoscopy Surgery in Gynecology

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01246323
First Posted: November 23, 2010
Last Update Posted: August 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
  Purpose
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 Intervention
Pain Procedure: Spinal anesthesia with Fentanyl+ Morphine

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • 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

  • 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.


Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: November 14, 2010
First Posted: November 23, 2010
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