Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty

Phase 4

• Conditions: Pain, Postoperative
• Interventions: Drug: Bupivacaine Hydrochloride, Spinal; Drug: Morphine hydrochloride, Spinal; Drug: Placebo - Concentrate

• Registration Number: NCT03434951
• Lead Sponsor: South Carelia Central Hospital

Brief Summary

Double-blinded randomized control study investigating intrathecal morphine as an additive to spinal anesthesia in patients undergoing elective total knee arthroplasty. The investigators aim to include a total of 120 patients, randomized to two equal groups. Participants in the intervention group are administered intrathecal 0,2mg morphine and 12,5mg bupivacaine for spinal anaesthesia. Participants in the placebo group are administered 12.5mg bupivacaine and saline to match the volume of intervention goup. Primary end points are opioid consumption and possible adverse effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-06
• Study First Submitted: 2017-12-10
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-14
• Last Update Submitted: 2018-02-14
• Study First Posted: 2018-02-15
• Last Update Posted: 2018-02-15
• Primary Completion: 2019-09-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• elective primary total knee arthroplasty
• ASA I-III
• written consent

Exclusion Criteria

• rearthroplasty
• ASA IV-V
• inadequate spoken finnish for reliable pain assessment
• Dementia or otherwise impaired cognition
• contraindication for any medication or substance used in survey protocol
• weight <50kg or BMI ≥35 kg/m2
• preoperative SpO2 less than 93%
• clinical suspicion that subject can not use PCA adequately
• history of substance abuse or current excessive use of alcohol
• preoperative use of either pregabalin, gabapentin or strong opiates

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal morphine and bupivacaine	Morphine hydrochloride, Spinal	0,2mg intrathecal morphine and 12,5mg bupivacaine administered
Intrathecal morphine and bupivacaine	Bupivacaine Hydrochloride, Spinal	0,2mg intrathecal morphine and 12,5mg bupivacaine administered
Placebo	Bupivacaine Hydrochloride, Spinal	12,5mg bupivacaine and NaCl 0,9% to match the same volume administered
Placebo	Placebo - Concentrate	12,5mg bupivacaine and NaCl 0,9% to match the same volume administered

Primary Outcome Measures

Name	Time	Method
intravenous oxycodone consumption	48 hours	Cumulative postoperative consumption

Secondary Outcome Measures

Name	Time	Method
Adverse effects of 0,2mg intrathecal morphine	48 hours	Possible nausea, vomiting, itching and respiratory depression
Mobilization time	48 hours	Assessing the time to ambulation
Patient satisfaction	28 days	Telephone interview 28 days after surgery

Trial Locations

Locations (1)

South Carelia Central Hospital; 🇫🇮 Lappeenranta, Finland