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Trial record 12 of 1298 for:    gynecology

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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ 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.


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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246323

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

Locations
Israel
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         
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   
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
Study First Received: November 14, 2010
Last Updated: August 4, 2011
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014