Combined Anesthesia for Laparoscopy Surgery in Gynecology
Recruitment status was Recruiting
The purpose of this study is to determine whether combined anesthesia will provide better pain control for the postoperative period following gynecological laparoscopy surgery.
|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|
- 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.
|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)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246323
|Contact: Lior Lowenstein, MD, MS||050-2061434||LowensteinMD@gmail.com|
|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 firstname.lastname@example.org|
|Contact: Dror Segal, MD 97248542382 email@example.com|
|Study Chair:||Lior Lowenstein||Rambam Health Care Campus|