We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772187
First Posted: October 15, 2008
Last Update Posted: September 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.

Estimated Enrollment: 40
Study Start Date: October 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Dror Segal, M.D, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00772187     History of Changes
Other Study ID Numbers: Rambam2690CTIL
First Submitted: May 21, 2008
First Posted: October 15, 2008
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