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

Phase 4

Completed

• Conditions: Popliteal Plexus Block; Total Knee Arthroplasty
• Interventions: Drug: Bupivacaine-epinephrine

• Registration Number: NCT03198403
• Lead Sponsor: Regionshospitalet Silkeborg

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 Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-23
• Study First Posted: 2017-06-26
• Study Start: 2017-08-01
• Status Verified: 2017-09
• Primary Completion: 2017-09-26
• Study Completion: 2017-09-28
• Last Update Submitted: 2017-09-28
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Popliteal plexus block	Bupivacaine-epinephrine	Patients with an FTB, reporting postoperative pain (NRS \> 3) will have a popliteal plexus block

Primary Outcome Measures

Name	Time	Method
The percentage of patients with postoperative pain NRS	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 Outcome Measures

Name	Time	Method
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)	Percentage of patients having a FTB, reporting postoperative pain NRS \>3
Turn off time of spinal anesthesia	Time from arrival in PACU and during maximum 6 hours	Time from arrival in PACU to normal cutaneous sensation (measured by a neuro-pen, sensation=point 2) on the lateral part of the thigh and lateral part of the lower leg
The effect of the PPB on cutaneous sensation	NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)	Tested on the lateral part of the lower leg
The effect of the PPB on muscle strength of the foot	Baseline and 1 hour after PPB	Dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer
Onset time of PPB	NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)	Time from end of injection of PPB to NRS = or \< 3
Correlation between normal cutaneous sensation and developing of pain	From arrival in PACU and during maximum 6 hours	Correlation between normal cutaneous sensation (measured by a neuro-pen, sensation=point 2) and developing of pain (NRS\>3)

Trial Locations

Locations (1)

Silkeborg Regionalhospital; 🇩🇰 Silkeborg, Denmark