Efficacy and Side Effects of Intrathecal Morphine in Multimodal Analgesia for Unilateral Total Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 131
- Locations
- 1
- Primary Endpoint
- Numerical rating scale
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
In the anesthetic record, 0.5% isobaric bupivacaine with study drug is recorded.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Procedure)
No IT morphine
Spinal block with 0.5% isobaric with no intrathecal morphine
Intervention: Morphine (Drug)
No IT morphine
Spinal block with 0.5% isobaric with no intrathecal morphine
Intervention: Bupivacaine (Drug)
50 ug IT morphine
Spinal block with 0.5% isobaric with 50 ug intrathecal morphine
Intervention: 50 ug IT morphine (Procedure)
50 ug IT morphine
Spinal block with 0.5% isobaric with 50 ug intrathecal morphine
Intervention: Morphine (Drug)
50 ug IT morphine
Spinal block with 0.5% isobaric with 50 ug intrathecal morphine
Intervention: Bupivacaine (Drug)
100 ug IT morphine
Spinal block with 0.5% isobaric with 100 ug intrathecal morphine
Intervention: 100 ug IT morphine (Procedure)
100 ug IT morphine
Spinal block with 0.5% isobaric with 100 ug intrathecal morphine
Intervention: Morphine (Drug)
100 ug IT morphine
Spinal block with 0.5% isobaric with 100 ug intrathecal morphine
Intervention: Bupivacaine (Drug)
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)
Investigators
Suwimon Tangwiwat
Assistant professor, Department of Anesthesiology
Mahidol University