Infiltration or Nerve Blocks in Addition to Adductor Canal Block

NCT06920186 | Not Yet Recruiting

• 2 other identifiers: COS-RGDS-2024-06-006-P-ELMALEH2024-A02496-41
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to evaluate the analgesic efficacy of this quadruple sensory block compared with the currently recommended procedure (adductor canal block + infiltration).

Conditions

Gonarthrosis; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Patient's recovery at H24 as after surgery assessed by the QoR-15 (Quality of Recovery) questionnaire score

  The QoR-15 score at H24 after surgery was compared between the two groups for primary endpoint analysis. The QoR-15 accurately measures postoperative recovery by focusing on 5 key domains: pain, physical comfort, physical independence, psychological support and emotional state. Each item is rated from 0 (unfavorable) to 10 (favorable), with an overall score corresponding to the sum of the score obtained for each item, i.e. a score from 0 (no recovery) to 150 (full recovery).

  From enrollement to the last H24 after surgery

Secondary Outcomes (22)

• Knee functional assessment

  Hour 0

• Post operative pain

  Hour 2

• Post operative pain

  Hour 6

• Post operative pain

  Hour 12

• First ambulation

  Hour 12

Study Arms (2)

Group 1 of local analgesia protocol (PROSPECT recommandations)

SHAM COMPARATOR

Locoregional analgesia (LRA) protocol n°1 : adductor canal block + surgical infiltration (PROSPECT recommendations)

Procedure: Analgesia

Group 2 of local analgesia protocol (quadri-peripheral nerve block )

EXPERIMENTAL

Locoregional analgesia (LRA) protocol n° 2 : adductor canal block + femoral-cutaneous block + obturator block + IPACK block

Procedure: Analgesia

Interventions

Analgesia PROCEDURE

1- Real Adductor canal block + surgical infiltration and sham of femoro-cutaneous block + obturator block + IPACK block with physiological serum

Group 1 of local analgesia protocol (PROSPECT recommandations)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female
• Patient with signed consent to participate in the study,
• Patient with uni or bilateral primary gonarthrosis
• Indication for total knee arthroplasty.

You may not qualify if:

• History of knee fracture, arthroplasty or osteotomy
• Known or unknown contraindication to ALR or locoregional anesthesia products
• Neurological disease, stroke sequelae
• Mental deficiency or any other reason that may hinder understanding or strict application of the protocol
• Patient not affiliated to the French social security system
• Patient under court protection, guardianship or curatorship
• Pregnant or potentially pregnant women (women of childbearing age without effective contraception)
• Patient already included in another therapeutic study protocol

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (2)

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

Clinique des Côtes du Rhône

Roussillon, 38150, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Category 2 Research Involving the Human Person (RIPH 2) : Multi-center (2 sites), prospective, double-blind randomized, open-label study of two parallel groups of patients undergoing total knee arthroplasty according to locoregional analgesia (LRA) protocol : * Group 1: Real adductor canal block + surgical infiltration and sham of femoro-cutaneous block + obturator block + IPACK block with physiological serum * Group 2: Real adductor canal block + femoro-cutaneous block + obturator block + IPACK block and sham of surgical infiltration with physiological serum

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 9, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)