The effect of spinally administered morphine on pain after total knee arthroplasty
Phase 1
- Conditions
- Postoperative pain after total knee arthroplastyMedDRA version: 20.0 Level: LLT Classification code 10003398 Term: Arthroplasty of knee System Organ Class: 100000021309Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2017-002170-39-FI
- Lead Sponsor
- Eksote
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
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
- age <18 or >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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