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Clinical Trials/NCT03198403
NCT03198403CompletedPhase 4

The Effect of Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty

Regionshospitalet Silkeborg1 site in 1 country17 target enrollmentStarted: August 1, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
17
Locations
1
Primary Endpoint
The percentage of patients with postoperative pain NRS

Study Overview

Brief Summary

The study aims to investigate the effect of the Popliteal plexus block (PPB) on postoperative pain after total knee arthroplasty

Detailed Description

Cadaver dissection studies have shown a spread of dye to the popliteal fossa and colored the popliteal plexus by injecting in the distal part of the adductor Canal.

The popliteal plexus is formed by contribution from the tibial and the obturator nerves.

Investigators hypothesized that a PPB may reduce postoperative pain after total knee arthroplasty.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients undergoing total knee arthroplasty in spinal anesthesia
  • age > or = 18 years
  • American Society of Anesthesiologists (ASA) status I-III
  • Informed consent

Exclusion Criteria

  • Patients unable to cooperate
  • Patients not able to speak Danish
  • Pregnancy
  • Contraindication towards ana Medical product used in the study
  • Preoperatively reduced sensation on the medial and lateral part of the lower leg
  • Patients with diabetic requiring Medical treatment
  • Preoperative daily intake of opioids

Arms & Interventions

Popliteal plexus block

Experimental

Patients with an FTB, reporting postoperative pain (NRS > 3) will have a popliteal plexus block

Intervention: Bupivacaine-epinephrine (Drug)

Outcomes

Primary Outcomes

The percentage of patients with postoperative pain NRS

Time Frame: 0 - 60 minutes

Evaluated as the percentage of patients with postoperative pain NRS \>3, dropping in pain score to NRS = or \< 3 after the PPB

Secondary Outcomes

  • Percentage of patients having a femoral triangle block(FTB) reporting NRS > 3(Pain scores every 15 minutes (from end injection FTB to NRS>3 or 3 hours after full sensation of the leg))
  • Turn off time of spinal anesthesia(Time from arrival in PACU and during maximum 6 hours)
  • The effect of the PPB on cutaneous sensation(NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB))
  • The effect of the PPB on muscle strength of the foot(Baseline and 1 hour after PPB)
  • Onset time of PPB(NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB))
  • Correlation between normal cutaneous sensation and developing of pain(From arrival in PACU and during maximum 6 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Charlotte Runge

Consultant anesthetist, Principal investigator

Regionshospitalet Silkeborg

Study Sites (1)

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