Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.

September 21, 2010 updated by: Rambam Health Care Campus
Main Hypothesis: laparoscopic surgery is very painful to patient during and after surgery. We would like to compare different analgesic methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal
  • contra-indication for treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Good analgesic method with minimal side effect.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

May 21, 2008

First Submitted That Met QC Criteria

October 14, 2008

First Posted (Estimate)

October 15, 2008

Study Record Updates

Last Update Posted (Estimate)

September 22, 2010

Last Update Submitted That Met QC Criteria

September 21, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rambam2690CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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