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Intrathecal Morphine for Unilateral Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03232957
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Suwimon Tangwiwat, Mahidol University

Brief Summary:
This study evaluates postoperative numerical pain score and systemic opioid requirement within 48 hours for unilateral total knee arthroplasty. Comparing among 3 groups of intrathecal morphine; 0,50, 100 ug with multimodal analgesia.

Condition or disease Intervention/treatment Phase
Primary Osteoarthritis of Knee Nos Procedure: 50 ug IT morphine Procedure: 100 ug IT morphine Procedure: No IT morphine Drug: Morphine Drug: Bupivacaine Not Applicable

Detailed Description:

Intrathecal opioid is effective postoperative analgesia for orthopedic lower extremity surgery. However there are some limitations such as nausea, vomiting, pruritus, dizziness. Nowadays multimodal analgesia is used in unilateral total knee arthroplasty include oral analgesic drugs, adductor canal block and local analgesia infiltration.

This study evaluates whether intrathecal opioid should be added in the role of multimodal analgesia in total knee arthroplasty.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: In the anesthetic record, 0.5% isobaric bupivacaine with study drug is recorded.
Primary Purpose: Treatment
Official Title: Efficacy and Side Effects of Intrathecal Morphine in Multimodal Analgesia for Unilateral Total Knee Arthroplasty
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: No IT morphine
Spinal block with 0.5% isobaric with no intrathecal morphine
Procedure: No IT morphine
Spinal block with bupivacaine and intrathecal morphine 0 ug

Drug: Morphine
intrathecal morphine

Drug: Bupivacaine
0.5 isobaric bupivacaine

Experimental: 50 ug IT morphine
Spinal block with 0.5% isobaric with 50 ug intrathecal morphine
Procedure: 50 ug IT morphine
Spinal block with bupivacaine and intrathecal morphine 50 ug

Drug: Morphine
intrathecal morphine

Drug: Bupivacaine
0.5 isobaric bupivacaine

Experimental: 100 ug IT morphine
Spinal block with 0.5% isobaric with 100 ug intrathecal morphine
Procedure: 100 ug IT morphine
Spinal block with bupivacaine and intrathecal morphine 100 ug

Drug: Morphine
intrathecal morphine

Drug: Bupivacaine
0.5 isobaric bupivacaine




Primary Outcome Measures :
  1. Numerical rating scale [ Time Frame: Within 48 hours ]
    Numerical rating scale 0-10


Secondary Outcome Measures :
  1. Morphine requirement [ Time Frame: Within 48 hours ]
    Systemic morphine requirement

  2. Nausea vomiting [ Time Frame: Within 48 hours ]
    Incidence and severity of nausea and vomiting

  3. Pruritus [ Time Frame: Within 48 hours ]
    Incidence and severity of pruritus



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged more than 18 years old undergoing unilateral total knee arthroplasty
  • American Society of Anesthesiologists physical status classification 1-3

Exclusion Criteria:

  • Participants deny to enroll the study
  • Allergy to local anesthetics, opioid and NSAIDs
  • Hepatic disease
  • Contraindication for neuraxial block or adductor canal block
  • Uncontrolled cardiovascular disease
  • Creatinine clearance less than 50 ml/min

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232957


Locations
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Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Suwimon Tangwiwat, MD Faculty of Medicine Siriraj Hospital
Publications:

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Responsible Party: Suwimon Tangwiwat, Assistant professor, Department of Anesthesiology, Mahidol University
ClinicalTrials.gov Identifier: NCT03232957    
Other Study ID Numbers: Si 331/2017
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suwimon Tangwiwat, Mahidol University:
Intrathecal morphine, total knee arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics