Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty

NCT ID: NCT03434951

Last Updated: 2018-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2020-09-01

Brief Summary

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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

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intrathecal morphine and bupivacaine

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

Group Type EXPERIMENTAL

Bupivacaine Hydrochloride, Spinal

Intervention Type DRUG

Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia

Morphine hydrochloride, Spinal

Intervention Type DRUG

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

Placebo

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

Group Type ACTIVE_COMPARATOR

Bupivacaine Hydrochloride, Spinal

Intervention Type DRUG

Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia

Placebo - Concentrate

Intervention Type DRUG

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

Interventions

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Bupivacaine Hydrochloride, Spinal

Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia

Intervention Type DRUG

Morphine hydrochloride, Spinal

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

Intervention Type DRUG

Placebo - Concentrate

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

Intervention Type DRUG

Other Intervention Names

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physiologic saline solution

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Carelia Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Susanna Niinimäki

SRN/ Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seppo Mustola, MD, PhD

Role: STUDY_DIRECTOR

South Carelia Central Hospital

Locations

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South Carelia Central Hospital

Lappeenranta, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Susanna Niinimäki, BSc, SRN /Anesthesia

Role: CONTACT

+358406511388

Seppo Mustola, MD, PhD

Role: CONTACT

+358447915832

Facility Contacts

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Susanna Niinimäki, BSc, SRN /Anesthesia

Role: primary

+358406511388

MD, PhD

Role: backup

Other Identifiers

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KNEMO 01

Identifier Type: -

Identifier Source: org_study_id

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