The effect of a new technique for anesthetizing the nerves involved in pain after knee replacement

Phase 1

• Conditions: Postoperative posterior pain after total knee arthroplasty; MedDRA version: 20.0Level: PTClassification code 10023469Term: Knee arthroplastySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10002325Term: Anesthesia localSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-005180-40-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Last Update Posted: 17 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

- Male or female at least 50 years of age at screening
- Scheduled to undergo primary total knee arthroplasty in spinal anaesthesia
- Normal sensory function at the lateral part of the thigh and lower leg
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
- Able to provide informed consent

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Unable to cooperate and follow the study protocol
- Communication problems
- Allergic towards any medical product administered in the study
- Diabetes requiring medical treatment
- Pregnancy (a pregnancy test will be conducted on all women of childbearing potential prior to inclusion in the study. A positive test result will result in exclusion from the study)
- Preoperative opioid treatment (dosed > once daily)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the analgesic effect of the popliteal plexus block (PPB) as a supplement to a femoral triangle block (FTB) after total knee arthroplasty (TKA) <br>;Secondary Objective: To evaluate the effect of the popliteal plexus block (PPB) in relation to opioid consumption, effect on sensory function and motor strength and to assess the onset time of the PPB. Furthermore, we aim to assess the number of patients who require a PBB as a supplement to a FTB.;Primary end point(s): Success of the PPB is defined as the proportion of patients with significant postoperative pain (NRS > 3) after FTB, who drop in pain score to NRS = 3 after PPB and maintain NRS = 3 without any opioids until 60 minutes after PPB. ;Timepoint(s) of evaluation of this end point: After placement of the PPB, pain scores (NRS) are registered every 5 minutes until 15 minutes after PPB placement. Pain scores are registered again 30 min, 45 min and 60 min after PPB.