Addition of Popliteal Plexus Block to Continuous Femoral Nerve Block for Total Knee Arthroplasty

The popliteal plexus block has been described as an alternative analgesic postoperative pain treatment for total knee arthroplasty. It consists of injecting local anaeshetics inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor magnus muscle, in order to anesthetize the popliteal plexus. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore the objective of this study is to investigate the analgesic benefit of this block combined with a continuous femoral nerve block, on patients scheduled for total knee athroplasty.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Ropivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.5% Injectable Solution

Detailed Description

Patients scheduled to undergo total knee arthroplasty under general anesthesia will be randomly allocated to two groups: continuous femoral nerve block alone or continuous femoral nerve block with addition of a popliteal plexus block.

The continuous femoral nerve block will be performed by the anesthesiologist with 15 mLs of ropivacaine 0.5%, under ultrasound guidance before the beginning of the general anesthesia. The popliteal plexus block will be done by the anesthesiology, under ultrasound guidance, before the beginning of the surgery, under general anesthesia.

Postoperative analgesia will include acetaminophen (4 x 1000 mg), ibuprofen (3 x 400 mg) and a continuous infusion of Ropivacaine 0.2%.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Recruiting
    • Departement of Anesthesia, Hôpitaux Universitaires de Genève
    • Contact: Kevin Stebler, MD; Phone Number: 0041795532149; Email: kevin.stebler@hcuge.ch
    • Contact: Roxane Fournier, PD; Phone Number: 0041795532058; Email: roxabe.fournier@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for total knee athroplasty under general anesthesia
• ASA 1-3

Exclusion Criteria:

• Kidney disease with GFR < 50 ml/mn
• Daily opioid consumption > 1 month
• Allergy to local anesthetics
• Neurological problems of the lower extremity
• other contraindications to peripheral nerve blocks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Popliteal plexus block and continuous femoral nerve block	Drug: Ropivacaine 0.5% Injectable Solution; Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca; Other Names: Continous femoral nerve block; Drug: Ropivacaine 0.5% Injectable Solution; Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca.; Other Names: Continous femoral nerve block; Drug: Ropivacaine 0.5% Injectable Solution; Popliteal plexus block with injection of 15 mls of Ropivacain 0.5% inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor Magnus muscle, done under general anesthesia.; Other Names: Popliteal plexus block
Active Comparator: continuous femoral nerve block	Drug: Ropivacaine 0.5% Injectable Solution; Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca; Other Names: Continous femoral nerve block; Drug: Ropivacaine 0.5% Injectable Solution; Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca.; Other Names: Continous femoral nerve block; Drug: Ropivacaine 0.5% Injectable Solution; Popliteal plexus block with injection of 15 mls of Ropivacain 0.5% inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor Magnus muscle, done under general anesthesia.; Other Names: Popliteal plexus block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total iv morphine consumption (mg)	12 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total iv morphine consumption (mg)		24 and 48 postoperative hours
Average and maximum pain scores (Numeric rating scale 0-10)		12, 24 and 48 postoperative hours
Sciatic extension of popliteal plexus block	Presence of sensitive or/and motor sciatic extension of popliteal plexus block	2 and 24 postoperative hours
Plantarflexion and dorsiflexion ankle strength (Newtons)		2 and 24 postoperative hours
Knee pain localization (anterior, internal, posterior, lateral, medial)		2, 12, 24 and 48 postoperative hours
Popliteal plexus block procedure time (minutes)	Onset of action = beginning of the disinfection; End of action = end of injection of 15 mls of Ropivacain 0.5%	When performing the popliteal plexus block
Popliteal plexus block duration of action (hours)	Onset of action = Time from end of infection of 15 mls of Ropivacain 0.5%; End of action = onset of lateral and/or posterior knee pain (With Numeric rating scale ≥ 4)	up to 48 postoperative hours

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: July 27, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ropivacaine
• Other Study ID Numbers: 2019-00655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No