Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty

South Carelia Central Hospital

Status and phase: Unknown; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Morphine hydrochloride, Spinal; Drug: Placebo - Concentrate; Drug: Bupivacaine Hydrochloride, Spinal

Study type: Interventional

Funder types: Other

Identifiers

NCT03434951

KNEMO 01

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Intrathecal morphine and bupivacaine

Experimental group

Description:

0,2mg intrathecal morphine and 12,5mg bupivacaine administered

Treatment:

Drug: Bupivacaine Hydrochloride, Spinal

Drug: Morphine hydrochloride, Spinal

Placebo

Active Comparator group

Description:

12,5mg bupivacaine and NaCl 0,9% to match the same volume administered

Treatment:

Drug: Placebo - Concentrate

Drug: Bupivacaine Hydrochloride, Spinal