Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty

Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty, a Randomized Controlled Study

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride, Spinal; Drug: Morphine hydrochloride, Spinal; Drug: Placebo - Concentrate

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Susanna Niinimäki, BSc, SRN /Anesthesia; Phone Number: +358406511388; Email: Susanna.niinimaki@eksote.fi
• Study Contact Backup: Name: Seppo Mustola, MD, PhD; Phone Number: +358447915832; Email: seppo.mustola@eksote.fi

Study Locations

• Finland
  • Lappeenranta, Finland, 53130
    • Recruiting
    • South Carelia Central Hospital
    • Contact: Susanna Niinimäki, BSc, SRN /Anesthesia; Phone Number: +358406511388; Email: Susanna.niinimaki@eksote.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrathecal morphine and bupivacaine; 0,2mg intrathecal morphine and 12,5mg bupivacaine administered	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)
Active Comparator: Placebo; 12,5mg bupivacaine and NaCl 0,9% to match the same volume administered	Drug: Bupivacaine Hydrochloride, Spinal; Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia; Drug: Placebo - Concentrate; Intrathecally administered saline solution 0,9% 0,1ml to match morphine volume; Other Names: physiologic saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intravenous oxycodone consumption	Cumulative postoperative consumption	48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: South Carelia Central Hospital
• Investigators: Study Director: Seppo Mustola, MD, PhD, South Carelia Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: December 10, 2017
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: KNEMO 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No