Intrathecal Morphine for Unilateral Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Primary Osteoarthritis of Knee Nos
• Interventions: Procedure: No IT morphine; Procedure: 50 ug IT morphine; Procedure: 100 ug IT morphine; Drug: Morphine; Drug: Bupivacaine

• Registration Number: NCT03232957
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-07-28
• Study Start: 2017-08-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-07-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No IT morphine	Bupivacaine	Spinal block with 0.5% isobaric with no intrathecal morphine
No IT morphine	Morphine	Spinal block with 0.5% isobaric with no intrathecal morphine
No IT morphine	No IT morphine	Spinal block with 0.5% isobaric with no intrathecal morphine
50 ug IT morphine	50 ug IT morphine	Spinal block with 0.5% isobaric with 50 ug intrathecal morphine
100 ug IT morphine	100 ug IT morphine	Spinal block with 0.5% isobaric with 100 ug intrathecal morphine
50 ug IT morphine	Morphine	Spinal block with 0.5% isobaric with 50 ug intrathecal morphine
50 ug IT morphine	Bupivacaine	Spinal block with 0.5% isobaric with 50 ug intrathecal morphine
100 ug IT morphine	Morphine	Spinal block with 0.5% isobaric with 100 ug intrathecal morphine
100 ug IT morphine	Bupivacaine	Spinal block with 0.5% isobaric with 100 ug intrathecal morphine

Primary Outcome Measures

Name	Time	Method
Numerical rating scale	Within 48 hours	Numerical rating scale 0-10

Secondary Outcome Measures

Name	Time	Method
Morphine requirement	Within 48 hours	Systemic morphine requirement
Nausea vomiting	Within 48 hours	Incidence and severity of nausea and vomiting
Pruritus	Within 48 hours	Incidence and severity of pruritus

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand