Combined Distal Femoral Nerve Block for Pain Control After Knee Replacement (FEM-COMB)

June 4, 2026 updated by: Ramsay Générale de Santé

Comparative Study Assessing the Efficacy of a Combined Distal Femoral Nerve Block for Postoperative Analgesia Following Total Knee Arthroplasty (TKA)

The goal of this clinical trial is to see whether a combined distal femoral nerve block improves pain relief after total knee replacement in adults having planned surgery. The main questions it aims to answer are:

  • Does the combined distal femoral nerve block reduce the amount of opioid needed in the post-anesthesia recovery room?
  • Does it preserve quadriceps muscle strength while improving postoperative pain control?

Researchers will compare the combined distal femoral nerve block to a saphenous nerve block alone to see if the combined block provides better analgesia without reducing leg strength.

Participants will:

  • Receive either the combined distal femoral nerve block or the saphenous nerve block alone before surgery.
  • Also receive standard multimodal pain management, including anesthesia, surgical site infiltration, and postoperative pain medications.
  • Be assessed for pain, opioid use, nausea and vomiting, quadriceps strength, time to first standing, hospital stay length, and patient satisfaction from surgery until discharge.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Dijon, France, 21000
        • Hôpital privé Dijon Bourgogne
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients aged over 18 years.
  • Scheduled for total knee arthroplasty with multimodal analgesia.
  • Affiliated with or benefiting from a social security system.
  • Able to understand the study information and provide written informed consent.

Exclusion Criteria:

  • Emergency surgery.
  • Weight under 50 kg.
  • Body mass index over 40 kg/m².
  • Contraindication to nefopam, non-steroidal anti-inflammatory drugs, local anesthetics, or morphine.
  • Preoperative opioid use.
  • Antidepressant or gabapentinoid treatment.
  • Other planned surgical or medical procedures during the study period.
  • Participation in another clinical trial, or currently in an exclusion period from another trial.
  • Inability to understand study information for linguistic, psychological, cognitive, or literacy reasons.
  • Pregnancy, possible pregnancy without effective contraception, or breastfeeding.
  • Protected adults, including those under guardianship, curatorship, legal protection, detention, or otherwise unable to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined Distal Femoral Nerve Block
Participants receive an ultrasound-guided combined distal femoral nerve block targeting the saphenous nerve, vastus medialis nerve, and anterior femoral cutaneous nerves, using ropivacaine 2 mg/mL, 40 mL total, with clonidine 30 micrograms perineural and dexamethasone 8 mg IV. They also receive surgical site infiltration, general anesthesia, and standard multimodal analgesia.
Procedure: Combined distal femoral nerve block
Ultrasound-guided block targeting the saphenous nerve, vastus medialis nerve, and anterior femoral cutaneous nerves, using ropivacaine 2 mg/mL, 40 mL total, with clonidine 30 micrograms perineural and dexamethasone 8 mg IV.
Procedure: Standard perioperative care in both groups
General anesthesia, surgical site infiltration, and multimodal analgesia with paracetamol, nefopam, and ketoprofen.
Active Comparator: Saphenous Nerve Block Alone
Participants receive an ultrasound-guided saphenous nerve block at the adductor canal using ropivacaine 2 mg/mL, 20 mL total, with clonidine 30 micrograms perineural and dexamethasone 8 mg IV. They also receive surgical site infiltration, general anesthesia, and standard multimodal analgesia.
Procedure: Standard perioperative care in both groups
General anesthesia, surgical site infiltration, and multimodal analgesia with paracetamol, nefopam, and ketoprofen.
Procedure: Saphenous nerve block alone
Ultrasound-guided saphenous nerve block at the adductor canal, using ropivacaine 2 mg/mL, 20 mL total, with clonidine 30 micrograms perineural and dexamethasone 8 mg IV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Opioid Consumption in post-anesthesia care unit (PACU).
Time Frame: From arrival in PACU until discharge from PACU, on postoperative day 0.
Total amount of opioids consumed in the post-anesthesia care unit, converted into oral morphine equivalent.
From arrival in PACU until discharge from PACU, on postoperative day 0.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain During Regional Anesthesia
Time Frame: During block administration on postoperative day 0.
Pain experienced during the performance of the locoregional anesthesia, assessed using a 10-point visual analog scale (VAS), in which 0 indicates no pain and 10 indicates maximal pain.
During block administration on postoperative day 0.
Postoperative Pain in post-anesthesia care unit (PACU) and Ward
Time Frame: Twice in PACU on postoperative day 0 after extubation and before PACU discharge; three times on postoperative day 1; and at hospital discharge (up to 7 days).
Pain intensity measured with a 10-point visual analog scale (VAS), in which 0 indicates no pain and 10 indicates maximal pain.
Twice in PACU on postoperative day 0 after extubation and before PACU discharge; three times on postoperative day 1; and at hospital discharge (up to 7 days).
Quadriceps Motor Strength
Time Frame: Postoperative day 0 in PACU and postoperative day 1.
Quadriceps motor strength will be assessed using the Medical Research Council muscle strength scale, ranging from 0 to 5, where 0 indicates no visible contraction and 5 indicates normal strength; higher scores indicate better motor strength. Ability to perform an active straight-leg raise will be recorded as yes/no, and quadriceps tone will be clinically assessed for hypotonia, flaccidity, or contracture.
Postoperative day 0 in PACU and postoperative day 1.
Time to First Standing
Time Frame: Postoperative day 0.
Delay until first mobilization/first standing after surgery.
Postoperative day 0.
Postoperative Nausea and Vomiting
Time Frame: Postoperative day 0 in post-anesthesia care unit (PACU).
Incidence of postoperative nausea and vomiting in post-anesthesia care unit (PACU).
Postoperative day 0 in post-anesthesia care unit (PACU).
Oral Opioid Consumption on the Ward
Time Frame: Postoperative day 1 and until hospital discharge (up to 7 days).
Total oral opioid use during hospitalization, reported as oral morphine equivalent.
Postoperative day 1 and until hospital discharge (up to 7 days).
Co-analgesic Consumption
Time Frame: Postoperative day 1 and until hospital discharge (up to 7 days).
Use of co-analgesics including nefopam, paracetamol, opium, and ketoprofen during hospitalization.
Postoperative day 1 and until hospital discharge (up to 7 days).
Intraoperative Medication Use
Time Frame: Intraoperative period on postoperative day 0.
Consumption of hypotensive drugs, vasopressors, and opioids during surgery.
Intraoperative period on postoperative day 0.
Length of Hospital Stay
Time Frame: At hospital discharge, up to 7 days after surgery.
Duration of hospitalization after surgery.
At hospital discharge, up to 7 days after surgery.
Patient Satisfaction
Time Frame: At hospital discharge, up to 7 days after surgery.
Patient satisfaction will be assessed using the Evaluation du Vécu de l'Anesthésie Générale (EVAN-G), a validated 26-item self-administered perioperative satisfaction questionnaire. The EVAN-G includes six dimensions: attention, privacy, information, pain, discomfort, and waiting times. The global satisfaction index score ranges from 0 to 100, where 0 indicates the worst possible level of satisfaction and 100 indicates the best possible level of satisfaction; higher scores indicate greater patient satisfaction.
At hospital discharge, up to 7 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramsay Générale de Santé

Investigators

  • Principal Investigator: Antoine Sanchez, MD, Hôpital privé Dijon Bourgogne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 25, 2026

Primary Completion (Estimated)

May 25, 2027

Study Completion (Estimated)

May 25, 2027

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COS-RGDS-2025-06-051-P-SANCHEZ
  • 2025-A02529-40 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in the published article will be made available, together with the study protocol and statistical analysis plan, after publication of the main results. Data sharing will be subject to sponsor approval, a methodologically sound proposal, signature of a data access agreement, and compliance with GDPR.

IPD Sharing Time Frame

Beginning 6 months and ending 36 months after publication of the main results

IPD Sharing Access Criteria

Requests should be addressed to the corresponding author and will be reviewed by the sponsor; data will be shared with researchers providing a methodologically sound proposal, after signature of a data access agreement and in compliance with GDPR.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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