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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


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
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