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

NCT ID: NCT00795223

Last Updated: 2009-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Post Operative Pain Total Knee Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

morphine and bupivacaine

Intervention Type DRUG

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

2

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

Group Type ACTIVE_COMPARATOR

spinal morphine and marcaine

Intervention Type DRUG

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

3

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

Group Type ACTIVE_COMPARATOR

morphine and bupivacaine

Intervention Type DRUG

0.2 mg morphine for spinal 0.5% bupivacaine for femoral nerve block

4

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

Group Type ACTIVE_COMPARATOR

morphine and bupivacaine

Intervention Type DRUG

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

Interventions

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morphine and bupivacaine

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

Intervention Type DRUG

spinal morphine and marcaine

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

Intervention Type DRUG

morphine and bupivacaine

0.2 mg morphine for spinal 0.5% bupivacaine for femoral nerve block

Intervention Type DRUG

morphine and bupivacaine

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

Intervention Type DRUG

Other Intervention Names

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marcaine marcaine marcaine marcaine

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siriraj Hospital

OTHER

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Siriraj Hospital

Principal Investigators

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Thitima Chinachoti, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Siriraj Hospital

Bangkok, Bangkoknoi, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Grant by the siriraj Hospital

Identifier Type: -

Identifier Source: secondary_id

461/2551(EC1)

Identifier Type: -

Identifier Source: org_study_id