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Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty

NCT03434951 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-02-15

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Bupivacaine Hydrochloride, Spinal

Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia

DRUG

Morphine hydrochloride, Spinal

Intrathecally administered morphine 0,2mg (2mg/ml, 0,1ml)

DRUG

Placebo - Concentrate

Intrathecally administered saline solution 0,9% 0,1ml to match morphine volume

Sponsors & Collaborators

  • South Carelia Central Hospital

    lead OTHER

Principal Investigators

  • Seppo Mustola, MD, PhD · South Carelia Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2019-09-01
Completion
2020-09-01

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03434951 on ClinicalTrials.gov