NCT04048889

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

July 27, 2019

Last Update Submit

August 6, 2019

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Total iv morphine consumption (mg)

    12 postoperative hours

Secondary Outcomes (7)

  • 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

    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

  • +2 more secondary outcomes

Study Arms (2)

Popliteal plexus block and continuous femoral nerve block

EXPERIMENTAL
Drug: Ropivacaine 0.5% Injectable Solution

continuous femoral nerve block

ACTIVE COMPARATOR
Drug: Ropivacaine 0.5% Injectable Solution

Interventions

Ropivacaine 0.5% Injectable SolutionDRUG

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

Also known as: Continous femoral nerve block
continuous femoral nerve block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Anesthesia, Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

RECRUITING

Related Publications (1)

  • Stebler K, Elia N, Zaccaria I, Fournier RM. Popliteal plexus block in total knee arthroplasty: a single-center randomized controlled double-blinded trial. Reg Anesth Pain Med. 2024 Dec 20:rapm-2024-105782. doi: 10.1136/rapm-2024-105782. Online ahead of print.

    PMID: 39709189DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Kevin Stebler, MD

CONTACT

0041795532149kevin.stebler@hcuge.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled triple-blinded trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2019

First Posted

August 7, 2019

Study Start

July 22, 2019

Primary Completion

March 1, 2022

Study Completion

July 1, 2022

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

CH(1)