Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.

Analgesia Clinical Trial

Official title:

Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772187
• Other study ID #: Rambam2690CTIL
• Status: Completed
• Phase: Phase 4
• First received: May 21, 2008
• Last updated: September 21, 2010
• Start date: October 2007
• Est. completion date: September 2009

Study information

• Verified date: July 2010
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Laparoscopic (general) Surgery

• Age>18

• ASA<4

• Morning surgery

Exclusion Criteria:

• Patient refusal

• contra-indication for treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• morphine
Single dose: 0.1-0.5 mg
• intrathecal analgesia (morphine)
0.1-0.5 mg of morphine
• general anesthesia (fentanyl)
general anesthesia alone

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Good analgesic method with minimal side effect.			Yes