Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.

• Sponsor: Rambam Health Care Campus (Other)
• Overall Status: Completed
• CT.gov ID: NCT00772187
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Drug: morphine; Drug: intrathecal analgesia (morphine); Drug: general anesthesia (fentanyl)	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Good analgesic method with minimal side effect. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Laparoscopic (general) Surgery

• Age>18

• ASA<4

• Morning surgery

Exclusion Criteria:

• Patient refusal

• contra-indication for treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam Health Care Campus	Haifa		Israel	31096

Sponsors and Collaborators

• Rambam Health Care Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00772187
• Other Study ID Numbers: Rambam2690CTIL
• First Posted: Oct 15, 2008
• Last Update Posted: Sep 22, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Laparoscopic surgery (general surgery).
• Additional relevant MeSH terms: Agnosia; Fentanyl; Morphine

Study Results

No Results Posted as of Sep 22, 2010