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

September 28, 2009 updated by: Mahidol University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkoknoi
      • Bangkok, Bangkoknoi, Thailand, 10700
        • Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Injection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine
Drug: morphine and bupivacaine
0.3 mg morphine for spinal together with 0.5% bupivacaine for femoral nerve block
Other Names:
  • marcaine
Drug: morphine and bupivacaine
0.2 mg morphine for spinal 0.5% bupivacaine for femoral nerve block
Other Names:
  • marcaine
Drug: morphine and bupivacaine
0.2 mg morphine for spinal together with 0.25% bupivacaine for femoral nerve block
Other Names:
  • marcaine
ACTIVE_COMPARATOR: 2
Injection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine
Drug: spinal morphine and marcaine
0.3 mg spinal morphine together with 0.25% bupivacaine for femoral nerve block
Other Names:
  • marcaine
ACTIVE_COMPARATOR: 3
Injection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine
Drug: morphine and bupivacaine
0.3 mg morphine for spinal together with 0.5% bupivacaine for femoral nerve block
Other Names:
  • marcaine
Drug: morphine and bupivacaine
0.2 mg morphine for spinal 0.5% bupivacaine for femoral nerve block
Other Names:
  • marcaine
Drug: morphine and bupivacaine
0.2 mg morphine for spinal together with 0.25% bupivacaine for femoral nerve block
Other Names:
  • marcaine
ACTIVE_COMPARATOR: 4
Injection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine
Drug: morphine and bupivacaine
0.3 mg morphine for spinal together with 0.5% bupivacaine for femoral nerve block
Other Names:
  • marcaine
Drug: morphine and bupivacaine
0.2 mg morphine for spinal 0.5% bupivacaine for femoral nerve block
Other Names:
  • marcaine
Drug: morphine and bupivacaine
0.2 mg morphine for spinal together with 0.25% bupivacaine for femoral nerve block
Other Names:
  • marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global assessment in post operative pain control
Time Frame: Begining of first enrollment in december 2008
Begining of first enrollment in december 2008

Secondary Outcome Measures

Outcome Measure
Time Frame
Global assessment of post operative pain in 48 HOURS AND SIDE EFFECTS
Time Frame: first enrollment in December 2008
first enrollment in December 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Siriraj Hospital

Investigators

  • Principal Investigator: Thitima Chinachoti, MD, Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (ESTIMATE)

November 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2009

Last Update Submitted That Met QC Criteria

September 28, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 461/2551(EC1)
  • Grant by the siriraj Hospital

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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