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

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

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

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty; Popliteal Plexus Block
• Intervention / Treatment: Drug: Bupivacaine-epinephrine

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Silkeborg, Denmark, 8600
    • Silkeborg Regionalhospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Popliteal plexus block; Patients with an FTB, reporting postoperative pain (NRS > 3) will have a popliteal plexus block	Drug: Bupivacaine-epinephrine; Popliteal plexus block with 10 mL of bupivacaine-epinephrine 5 mg/mL + 5 microgram/mL.
No Intervention: No intervention; Patients with postoperative pain NRS < or = 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of patients with postoperative pain NRS	Evaluated as the percentage of patients with postoperative pain NRS >3, dropping in pain score to NRS = or < 3 after the PPB	0 - 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients having a femoral triangle block(FTB) reporting NRS > 3	Percentage of patients having a FTB, reporting postoperative pain NRS >3	Pain scores every 15 minutes (from end injection FTB to NRS>3 or 3 hours after full sensation of the leg)
Onset time of PPB	Time from end of injection of PPB to NRS = or < 3	NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)
Turn off time of spinal anesthesia	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	Time from arrival in PACU and during maximum 6 hours
Correlation between normal cutaneous sensation and developing of pain	Correlation between normal cutaneous sensation (measured by a neuro-pen, sensation=point 2) and developing of pain (NRS>3)	From arrival in PACU and during maximum 6 hours
The effect of the PPB on cutaneous sensation	Tested on the lateral part of the lower leg	NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)
The effect of the PPB on muscle strength of the foot	Dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer	Baseline and 1 hour after PPB

Collaborators and Investigators

• Sponsor: Regionshospitalet Silkeborg
• Investigators: Principal Investigator: Charlotte Runge, MD, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): September 26, 2017
• Study Completion (Actual): September 28, 2017

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 26, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2017
• Last Update Submitted That Met QC Criteria: September 28, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: 2017-001644-35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No