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Clinical Trials/NCT03232957
NCT03232957
Completed
Not Applicable

Efficacy and Side Effects of Intrathecal Morphine in Multimodal Analgesia for Unilateral Total Knee Arthroplasty

Mahidol University1 site in 1 country131 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
No IT morphine
Conditions
Primary Osteoarthritis of Knee Nos
Sponsor
Mahidol University
Enrollment
131
Locations
1
Primary Endpoint
Numerical rating scale
Status
Completed
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
July 31, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Suwimon Tangwiwat

Assistant professor, Department of Anesthesiology

Mahidol University

Eligibility 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

Arms & Interventions

No IT morphine

Spinal block with 0.5% isobaric with no intrathecal morphine

Intervention: No IT morphine

No IT morphine

Spinal block with 0.5% isobaric with no intrathecal morphine

Intervention: Morphine

No IT morphine

Spinal block with 0.5% isobaric with no intrathecal morphine

Intervention: Bupivacaine

50 ug IT morphine

Spinal block with 0.5% isobaric with 50 ug intrathecal morphine

Intervention: 50 ug IT morphine

50 ug IT morphine

Spinal block with 0.5% isobaric with 50 ug intrathecal morphine

Intervention: Morphine

50 ug IT morphine

Spinal block with 0.5% isobaric with 50 ug intrathecal morphine

Intervention: Bupivacaine

100 ug IT morphine

Spinal block with 0.5% isobaric with 100 ug intrathecal morphine

Intervention: 100 ug IT morphine

100 ug IT morphine

Spinal block with 0.5% isobaric with 100 ug intrathecal morphine

Intervention: Morphine

100 ug IT morphine

Spinal block with 0.5% isobaric with 100 ug intrathecal morphine

Intervention: Bupivacaine

Outcomes

Primary Outcomes

Numerical rating scale

Time Frame: Within 48 hours

Numerical rating scale 0-10

Secondary Outcomes

  • Morphine requirement(Within 48 hours)
  • Nausea vomiting(Within 48 hours)
  • Pruritus(Within 48 hours)

Study Sites (1)

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