Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03434951

Enrollment

120

Registered

2018-02-15

Start date

2017-11-06

Completion date

2020-09-01

Last updated

2018-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

DRUGBupivacaine Hydrochloride, Spinal

Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia

DRUGMorphine hydrochloride, Spinal

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

DRUGPlacebo - Concentrate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
intravenous oxycodone consumption	48 hours	Cumulative postoperative consumption

Secondary

Measure	Time frame	Description
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

Countries

Finland

Contacts

Primary ContactSusanna Niinimäki, BSc, SRN /Anesthesia

susanna.niinimaki@eksote.fi+358406511388

Backup ContactSeppo Mustola, MD, PhD

seppo.mustola@eksote.fi+358447915832

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026