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Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.

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ClinicalTrials.gov Identifier: NCT00772187
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : September 22, 2010
Sponsor:
Information provided by:
Rambam Health Care Campus

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

Condition or disease Intervention/treatment Phase
Analgesia Drug: morphine Drug: intrathecal analgesia (morphine) Drug: general anesthesia (fentanyl) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.
Study Start Date : October 2007
Primary Completion Date : September 2009
Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: 1
General anesthesia + I.V pca
Drug: general anesthesia (fentanyl)
general anesthesia alone
Experimental: 2
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



Primary Outcome Measures :
  1. Good analgesic method with minimal side effect.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal
  • contra-indication for treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772187


Locations
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus

Responsible Party: Dror Segal, M.D, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00772187     History of Changes
Other Study ID Numbers: Rambam2690CTIL
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: September 22, 2010
Last Verified: July 2010

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

Additional relevant MeSH terms:
Anesthetics
Fentanyl
Morphine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General