The effect of spinally administered morphine on pain after total knee arthroplasty

Combination of intrathecal morphine and local infiltration analgesia in treatment postoperative pain of total knee arthroplasty

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002170-39-FI

Enrollment

120

Registered

2017-08-16

Start date

2017-09-14

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Postoperative pain after total knee arthroplasty MedDRA version: 20.0 Level: LLT Classification code 10003398 Term: Arthroplasty of knee System Organ Class: 100000021309

Interventions

Trade Name: Morphin 2mg/ml Product Name: Morphin Pharmaceutical Form: Injection INN or Proposed INN: morfiinihydrokloridi CAS Number: 52

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 120 patients who have given their written consent - primary total knee arthroplasty - age 18-85 years - ASA I-III - suitable for spinal anesthesia - NSAID not contraindicated Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: - age 86 yrs - weight < 50 kgs or BMI =35 kg/m2 - ASA IV - V - reoperation - preoperative SpO2 <93% - dementia - drug or alcohol abuse - preoperative use of strong opioids, gabapentin or pregabalin - any drug of the research protocol is contraindicated

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the pain after total knee arthroplasty between patients who received both intrathecal morphine and local infiltration analgesia and local infiltration analgesia only.;Secondary Objective: To compare the side effects of the pain medication and mobilization between the groups;Primary end point(s): postoperative pain score (NRS) and consumption of additional oxycodone;Timepoint(s) of evaluation of this end point: 24 and 48 hours after operation	—

Measure

Time frame

Main Objective: To compare the pain after total knee arthroplasty between patients who received both intrathecal morphine and local infiltration analgesia and local infiltration analgesia only.;Secondary Objective: To compare the side effects of the pain medication and mobilization between the groups;Primary end point(s): postoperative pain score (NRS) and consumption of additional oxycodone;Timepoint(s) of evaluation of this end point: 24 and 48 hours after operation

—

Secondary

Measure	Time frame
Secondary end point(s): postoperative nausea and vomiting, pruritus, sedation and respiratory depression, mobilization, length of stay;Timepoint(s) of evaluation of this end point: 24 and 48 hours after operation	—

Countries

Finland

Contacts

Public ContactAnestesia- ja leikkausosasto

Eksote

susanna.niinimaki@eksote.fi+358408305304

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026