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

History of Changes

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:

Drug Information available for: Morphine sulfate Fentanyl Fentanyl citrate

U.S. FDA Resources

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:

American Society of Anesthesiology (ASA) physical status classification system:ASA I-III.
Benign Gynecological Laparoscopy surgery

Exclusion Criteria:

Patients who are not capable to sign the consent form.
Women with known allergy to the medication used in spinal analgesia.
Patients who are pregnant or lactating.
Patients with contraindication to spinal analgesia.
Patients who use opioid on a regular base.

Contacts and Locations

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:

Jones T, Tilsley DW, Wilson CB, Lammertsma AA, Brown G, Brady F, Price PM. Positron emission tomography for tumour assessment. NMR Biomed. 1992 Sep-Oct;5(5):265-9. Review.

Motamed C, Bouaziz H, Franco D, Benhamou D. Analgesic effect of low-dose intrathecal morphine and bupivacaine in laparoscopic cholecystectomy. Anaesthesia. 2000 Feb;55(2):118-24.

Kong SK, Onsiong SM, Chiu WK, Li MK. Use of intrathecal morphine for postoperative pain relief after elective laparoscopic colorectal surgery. Anaesthesia. 2002 Dec;57(12):1168-73.

Karaman S, Kocabas S, Uyar M, Zincircioglu C, Firat V. Intrathecal morphine: effects on perioperative hemodynamics, postoperative analgesia, and stress response for total abdominal hysterectomy. Adv Ther. 2006 Mar-Apr;23(2):295-306.

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
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Fentanyl
Morphine
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 19, 2013

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