NCT07477730

Brief Summary

Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedures and is associated with severe pain in the immediate postoperative period, thus limiting early recovery. Optimal postoperative pain management after TKA is not fully defined. While multimodal analgesia is standard, the choice of associated regional anesthesia techniques is debated. Local infiltration analgesia (LIA) is widely used and provides effective pain relief without impairing early mobilization. Peripheral nerve blocks have been discussed due to the risk of motor blockade, but low-concentration local anesthetics, such as 0.1% ropivacaine, allow sensory blockade while preserving motor function. Preliminary studies suggest that this concentration is effective and safe. The main objective of this monocenter, prospective, randomized, open-label, controlled trial is to compare the analgesic efficacy of a quadruple nerve blocks (femoral, sciatic, obturator, and lateral femoral cutaneous nerves) using 0.1% ropivacaine versus standard LIA in patients undergoing TKA.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

March 13, 2026

Last Update Submit

March 13, 2026

Conditions

Keywords

Knee arthroplastyLocal Infiltration AnalgesiaRegional anesthesiaRopivacainePostoperative analgesiaPain managementOpioids

Outcome Measures

Primary Outcomes (1)

  • Total opioid consumption within 24 hours

    Total cumulative opioid consumption during the first 24 hours, expressed in oral morphine equivalents (OME, mg), including intraoperative and postoperative opioid administration.

    From start of surgery (t0) to 24 hours postoperatively

Secondary Outcomes (15)

  • Intraoperative anesthetic consumption

    During surgery

  • Intraoperative opioid consumption

    During surgery

  • Intraoperative hypertension events

    During surgery

  • Intraoperative hypotension events

    During surgery

  • Postoperative pain intensity

    Up to 48 hours postoperatively

  • +10 more secondary outcomes

Study Arms (2)

LIA group

ACTIVE COMPARATOR

Local infiltration analgesia

Procedure: Surgical local infiltration

Quadruple nerve blocks group

EXPERIMENTAL

Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks

Procedure: Obturator nerve blockProcedure: Femoral nerve blockProcedure: Sciatic nerve blockProcedure: Lateral femoral cutaneous nerve block

Interventions

Injection of 150 mL of ropivacaine 0.2% into periarticular tissues according to a standardized sequence, including the posterior capsule, collateral ligaments, quadriceps, patellar tendon, capsule and subcutaneous tissue before wound closure

LIA group

Injection of 20 mL of 0.1% ropivacaine between the adductor magnus and adductor brevis muscles and between the adductor brevis and pectineus muscles

Quadruple nerve blocks group

Injection of 15 mL of 0.1% ropivacaine under the fascia iliaca, with the patient in supine position

Quadruple nerve blocks group

Injection of 20 mL of 0.1% ropivacaine in the subgluteal space via a lateral approach, with the patient in prone position

Quadruple nerve blocks group

Injection of 5 mL of 0.1% ropivacaine lateral to the sartorius muscle

Quadruple nerve blocks group

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing primary total knee arthroplasty under general anesthesia (laryngeal mask airway)
  • Fully autonomous at home
  • Planned discharge to home
  • Consent for participation
  • Affiliation to a social security system

You may not qualify if:

  • Preoperative opioid use
  • Chronic pain syndrome
  • Valgus contraindicating sciatic nerve block
  • Contraindication to any drugs used in the protocol
  • Contraindication to laryngeal mask airway
  • Pregnant or breastfeeding women
  • Patients under protection of the adults (guardianship, curators or safeguard of justice)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Médipôle Garonne

Toulouse, Haute-Garonne, 31036, France

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 17, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 2, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations