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Intrathecal Morphine for Unilateral Total Knee Arthroplasty

M

Mahidol University

Status

Completed

Conditions

Primary Osteoarthritis of Knee Nos

Treatments

Procedure: 50 ug IT morphine
Procedure: No IT morphine
Procedure: 100 ug IT morphine
Drug: Morphine
Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03232957
Si 331/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment

131 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

131 participants in 3 patient groups

No IT morphine
Experimental group
Description:
Spinal block with 0.5% isobaric with no intrathecal morphine
Treatment:
Drug: Morphine
Procedure: No IT morphine
Drug: Bupivacaine
50 ug IT morphine
Experimental group
Description:
Spinal block with 0.5% isobaric with 50 ug intrathecal morphine
Treatment:
Drug: Morphine
Procedure: 50 ug IT morphine
Drug: Bupivacaine
100 ug IT morphine
Experimental group
Description:
Spinal block with 0.5% isobaric with 100 ug intrathecal morphine
Treatment:
Drug: Morphine
Procedure: 100 ug IT morphine
Drug: Bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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