Comparative Pain Control Between 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for FNB After TKA

Post Operative Pain Clinical Trial

Official title:

Comparative Effect of 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for Femoral Nerve Block After Total Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795223
• Other study ID #: 461/2551(EC1)
• Secondary ID: Grant by the sir
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2008
• Last updated: September 28, 2009
• Start date: October 2008
• Est. completion date: May 2009

Study information

• Verified date: September 2009
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Comparative efficacy of 24 and 48 hours post operative pain control in single total knee replacement between intrathecal bupivacaine with 0.2 or 0.3 mg morphine together with 0.25 or 0.5 % bupivacaine for single femoral nerve block

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Single elective total knee replacement in ASA 1-3 without significant cardiovascular limitation

Exclusion Criteria:

• patient at risk in usage COX-2 for post operative pain control

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain
• Total Knee Replacement

Intervention

Drug:
• morphine and bupivacaine
0.3 mg morphine for spinal together with 0.5% bupivacaine for femoral nerve block
• spinal morphine and marcaine
0.3 mg spinal morphine together with 0.25% bupivacaine for femoral nerve block
• morphine and bupivacaine
0.2 mg morphine for spinal 0.5% bupivacaine for femoral nerve block
• morphine and bupivacaine
0.2 mg morphine for spinal together with 0.25% bupivacaine for femoral nerve block

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok	Bangkoknoi

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global assessment in post operative pain control		Begining of first enrollment in december 2008	No
Secondary	Global assessment of post operative pain in 48 HOURS AND SIDE EFFECTS		first enrollment in December 2008	No