Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00772187
First received: May 21, 2008
Last updated: September 21, 2010
Last verified: July 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

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

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

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
  • contra-indication for treatment
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772187

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

No publications provided

Responsible Party: Dror Segal, M.D, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00772187     History of Changes
Other Study ID Numbers: Rambam2690CTIL
Study First Received: May 21, 2008
Last Updated: September 21, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

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

ClinicalTrials.gov processed this record on September 22, 2014