search
Back to results

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

Primary Purpose

Post Operative Pain, Total Knee Replacement

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
morphine and bupivacaine
spinal morphine and marcaine
morphine and bupivacaine
morphine and bupivacaine
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Global assessment in post operative pain control

Secondary Outcome Measures

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

Full Information

First Posted
November 20, 2008
Last Updated
September 28, 2009
Sponsor
Mahidol University
Collaborators
Siriraj Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00795223
Brief Title
Comparative Pain Control Between 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for FNB After TKA
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mahidol University
Collaborators
Siriraj Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Total Knee Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Injection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Injection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine
Arm Title
3
Arm Type
Active Comparator
Arm Description
Injection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine
Arm Title
4
Arm Type
Active Comparator
Arm Description
Injection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
morphine and bupivacaine
Other Intervention Name(s)
marcaine
Intervention Description
0.3 mg morphine for spinal together with 0.5% bupivacaine for femoral nerve block
Intervention Type
Drug
Intervention Name(s)
spinal morphine and marcaine
Other Intervention Name(s)
marcaine
Intervention Description
0.3 mg spinal morphine together with 0.25% bupivacaine for femoral nerve block
Intervention Type
Drug
Intervention Name(s)
morphine and bupivacaine
Other Intervention Name(s)
marcaine
Intervention Description
0.2 mg morphine for spinal 0.5% bupivacaine for femoral nerve block
Intervention Type
Drug
Intervention Name(s)
morphine and bupivacaine
Other Intervention Name(s)
marcaine
Intervention Description
0.2 mg morphine for spinal together with 0.25% bupivacaine for femoral nerve block
Primary Outcome Measure Information:
Title
Global assessment in post operative pain control
Time Frame
Begining of first enrollment in december 2008
Secondary Outcome Measure Information:
Title
Global assessment of post operative pain in 48 HOURS AND SIDE EFFECTS
Time Frame
first enrollment in December 2008

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thitima Chinachoti, MD
Organizational Affiliation
Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkok
State/Province
Bangkoknoi
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs