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Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.
This study is currently recruiting participants.
Verified by Rambam Health Care Campus, October 2008
Sponsored by: Rambam Health Care Campus
Information provided by: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00772187
  Purpose

Main Hypothesis: laparoscopic surgery is very painful to patient during and after surgery. We would like to compare different analgesic methods.


Condition Intervention Phase
Analgesia
Drug: morphine
Drug: intrathecal analgesia (morphine)
Drug: general anesthesia (fentanyl)
Phase IV

MedlinePlus related topics: Anesthesia
Drug Information available for: Fentanyl Citrate Fentanyl
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Good analgesic method with minimal side effect. [ Time Frame: . ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: October 2007
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
General anesthesia + I.V pca
Drug: general anesthesia (fentanyl)
general anesthesia alone
2: Experimental
General anesthesia + spinal analgesia + I.V pca
Drug: morphine
Single dose: 0.1-0.5 mg
Drug: intrathecal analgesia (morphine)
0.1-0.5 mg of morphine

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Laparoscopic (general) Surgery
  • Age>18
  • ASA<4
  • Morning surgery

Exclusion Criteria:

  • Patient refusal
  • Morbid obesity
  • contra-indication for treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772187

Contacts
Contact: Dror Segal, MD 972-5-0206-3681 d_segal@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Contact: Dror Segal, MD     972-4-584-2222 ext 2487     d_segal@rambam.health.gov.il    
Sponsors and Collaborators
Rambam Health Care Campus
  More Information

Responsible Party: Rambam Health Care Campus ( Dror Segal, M.D )
Study ID Numbers: Rambam2690CTIL
Study First Received: May 21, 2008
Last Updated: October 14, 2008
ClinicalTrials.gov Identifier: NCT00772187  
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
Laparoscopic surgery (general surgery).

Study placed in the following topic categories:
Morphine
Fentanyl

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 14, 2009