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Clinical Trials/EUCTR2017-002170-39-FI
EUCTR2017-002170-39-FI
Active, not recruiting
Phase 1

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

Eksote0 sites120 target enrollmentAugust 16, 2017
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ConditionsPostoperative 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]
DrugsMorphin 2mg/mlBicain Pond Spinal 5mg/mlToradol 30mg/mlRopivacaine Orion 2mg/mlAdrenalin 0.1mg/ml

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Postoperative pain after total knee arthroplasty
Sponsor
Eksote
Enrollment
120
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 16, 2017
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Eksote

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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