Skip to content

Comparison of Analgesic Efficacy and Impact on Motor Function in Knee Replacement Surgery: 0.1% Naropeine Tri-block Versus 0.5% Naropeine iPACK Saphenous Block - A Prospective Randomised Trial

Comparison of Analgesic Efficacy and Impact on Motor Function in Knee Replacement Surgery: 0.1% Naropeine Tri-block Versus 0.5% Naropeine iPACK Saphenous Block - A Prospective Randomised Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07578688
Acronym
ProBlocs
Enrollment
120
Registered
2026-05-11
Start date
2026-09-30
Completion date
2027-12-31
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Surgery

Brief summary

Over the last two decades, perioperative analgesia has evolved. Spinal and epidural anaesthesia, once common, have been gradually phased out due to their side effects. The femoral block combined with the sciatic block, possibly with a perineural catheter, is now the gold standard for ensuring prolonged, high-quality analgesia. However, these blocks can cause muscle weakness in the quadriceps, limiting patients' functional recovery. To optimise functional rehabilitation, recent techniques favour more distal and selective blocks, such as the adductor canal (saphenous) block and the iPACK, which allow effective anaesthesia to be maintained whilst preserving motor function. However, these blocks do not always guarantee complete analgesia and may require additional blocks. The hypothesis of the current study is based on the idea that a proximal block targeting the femoral, obturator and sciatic nerves, administered with a low concentration of naropeine (0.1%), could provide more effective analgesia than a 0.5% saphenous iPACK block, whilst preserving motor function The originality of our approach in the current study lies in the use of dissociative proximal blocks performed with low concentrations of local anaesthetics, aimed at effectively covering the innervation of the knee whilst preserving motor function. The expected outcomes of this research are to optimise analgesic management for patients undergoing functional orthopaedic knee surgery, to promote early postoperative walking rehabilitation, to reduce the risk of chronic pain following knee arthroplasty, and to provide evidence to guide anaesthetic and post-surgical rehabilitation practices

Interventions

OTHERTri-bloc

Injection of 0.1% naropeine for a femoral, obturator and sciatic block (Tri-block technique), combined with intraoperative intravenous administration of 0.15 mg/kg of dexamethasone.

OTHERiPACK saphène

Injection of 0.5% naropeine for an iPACK and saphenous nerve block (iPACK saphenous arm), combined with intraoperative intravenous administration of 0.15 mg/kg of dexamethasone.

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years; * Patients scheduled for total knee replacement (TKR); * ASA (American Society of Anesthesiologists) class 1 to 3; * Patient who is able to understand the information relating to the study, read the information leaflet and agree to sign the informed consent form; * Enrolment iin the French healthcare system.

Exclusion criteria

* Patients with an ASA score \> 3; * Patients with a chronic pain condition requiring regular prescription pain relief, such as osteoarthritis, fibromyalgia, neuropathic pain or rheumatoid arthritis; * Patients with a major anxiety disorder (APAIS score); * Patients with a history of algodystrophy; * Pregnant or breastfeeding women; * History or evidence of any other clinically significant disorder, condition or disease which, in the investigator's opinion, would pose a risk to patient safety or interfere with the assessment, procedures or completion of the study; * Participation in any other clinical trial during the duration of the study; * Patients under guardianship or curatorship or subject to deprivation of liberty.

Design outcomes

Primary

MeasureTime frame
Total morphine consumption in the postoperative period at 72 hours during the hospital stayfrom knee surgery (enrollment) to 3 days post-surgery

Countries

France

Contacts

CONTACTDr Emilie ELLIES DROUAUD
elliese64@gmail.com+33 (0)679324918

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026