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

NCT00795223 | Completed Phase 4

• 2 other identifiers: 461/2551(EC1)Grant by the siriraj Hospital
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Post Operative Pain; Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Global assessment in post operative pain control

  Begining of first enrollment in december 2008

Secondary Outcomes (1)

• Global assessment of post operative pain in 48 HOURS AND SIDE EFFECTS

  first enrollment in December 2008

Study Arms (4)

1

ACTIVE COMPARATOR

Injection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine

Drug: morphine and bupivacaine

2

ACTIVE COMPARATOR

Injection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine

Drug: spinal morphine and marcaine

3

ACTIVE COMPARATOR

Injection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine

Drug: morphine and bupivacaine

4

ACTIVE COMPARATOR

Injection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine

Drug: morphine and bupivacaine

Interventions

morphine and bupivacaine DRUG

0.3 mg morphine for spinal together with 0.5% bupivacaine for femoral nerve block

Also known as: marcaine

1

spinal morphine and marcaine DRUG

0.3 mg spinal morphine together with 0.25% bupivacaine for femoral nerve block

Also known as: marcaine

2

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead
• Siriraj Hospital: collaborator

Study Sites (1)

Siriraj Hospital

Bangkok, Bangkoknoi, 10700, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Thitima Chinachoti, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 29, 2009

Record last verified: 2009-09

Locations

TH (1)