Combined Anesthesia for Laparoscopy Surgery in Gynecology

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01246323
First received: November 14, 2010
Last updated: August 4, 2011
Last verified: November 2010

November 14, 2010
August 4, 2011
November 2010
November 2012   (final data collection date for primary outcome measure)
  • Pain level [ Time Frame: For the first 72 hours following surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of doses of analgesic medications will be collected from patients charts.
Same as current
Complete list of historical versions of study NCT01246323 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Combined Anesthesia for Laparoscopy Surgery in Gynecology
Combined General and Spinal Anesthesia vs. General Anesthesia for Pain Relief During Laparoscopy Gynecological Surgery

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Pain
Procedure: Spinal anesthesia with Fentanyl+ Morphine
Fentanyl 15 microgram Morphine 0.1-0.5 mg
  • Active Comparator: combined anesthesia
    Patients will receive spinal and general anesthesia for benign laparoscopy gynecological surgery
    Intervention: Procedure: Spinal anesthesia with Fentanyl+ Morphine
  • No Intervention: Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2012
November 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 70 Years
No
Contact: Lior Lowenstein, MD, MS 050-2061434 LowensteinMD@gmail.com
Israel
 
NCT01246323
COBINED ANASTHESIA GYNECOLOGY
No
Lior Lowenstein, Rambam Health Care Campus
Rambam Health Care Campus
Not Provided
Study Chair: Lior Lowenstein Rambam Health Care Campus
Rambam Health Care Campus
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP