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Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.

Primary Purpose

Analgesia

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
morphine
intrathecal analgesia (morphine)
general anesthesia (fentanyl)
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring Laparoscopic surgery (general surgery).

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal
  • contra-indication for treatment

Sites / Locations

  • Rambam Health Care Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

General anesthesia + I.V pca

General anesthesia + spinal analgesia + I.V pca

Outcomes

Primary Outcome Measures

Good analgesic method with minimal side effect.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2008
Last Updated
September 21, 2010
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT00772187
Brief Title
Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.
Official Title
Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rambam Health Care Campus

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
Keywords
Laparoscopic surgery (general surgery).

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
General anesthesia + I.V pca
Arm Title
2
Arm Type
Experimental
Arm Description
General anesthesia + spinal analgesia + I.V pca
Intervention Type
Drug
Intervention Name(s)
morphine
Intervention Description
Single dose: 0.1-0.5 mg
Intervention Type
Drug
Intervention Name(s)
intrathecal analgesia (morphine)
Intervention Description
0.1-0.5 mg of morphine
Intervention Type
Drug
Intervention Name(s)
general anesthesia (fentanyl)
Intervention Description
general anesthesia alone
Primary Outcome Measure Information:
Title
Good analgesic method with minimal side effect.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Laparoscopic (general) Surgery Age>18 ASA<4 Morning surgery Exclusion Criteria: Patient refusal contra-indication for treatment
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.

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