Combined Anesthesia for Laparoscopy Surgery in Gynecology

Pain Clinical Trial

Official title:

Combined General and Spinal Anesthesia vs. General Anesthesia for Pain Relief During Laparoscopy Gynecological Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01246323
• Other study ID #: COBINED ANASTHESIA GYNECOLOGY
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2010
• Last updated: August 4, 2011
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2010
• Source: Rambam Health Care Campus
• Contact: Lior Lowenstein, MD, MS
• Phone: 050-2061434
• Email: LowensteinMD[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Spinal anesthesia with Fentanyl+ Morphine
Fentanyl 15 microgram Morphine 0.1-0.5 mg

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level	Pain level will be evaluated every 4 hours from the time of surgery to discharge	For the first 72 hours following surgery	No
Primary	Number of doses of analgesic drugs	Number of doses of analgesic medications will be collected from patients charts.	For the first 72 hours following surgery	No