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NCT Number: NCT07629388

Combined Distal Femoral Nerve Block for Pain Control After Knee Replacement

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.

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Key information

Conditions

Pain After Total Knee Arthroplasty Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combined distal femoral nerve block

Procedure

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.

Saphenous nerve block alone

Procedure

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.

Standard perioperative care in both groups

Procedure

General anesthesia, surgical site infiltration, and multimodal analgesia with paracetamol, nefopam, and ketoprofen.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Time to First Standing

    Time frame: Postoperative day 0.

    Delay until first mobilization/first standing after surgery.

  5. 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).

  6. 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.

  7. 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.

  8. Intraoperative Medication Use

    Time frame: Intraoperative period on postoperative day 0.

    Consumption of hypotensive drugs, vasopressors, and opioids during surgery.

  9. Length of Hospital Stay

    Time frame: At hospital discharge, up to 7 days after surgery.

    Duration of hospitalization after surgery.

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine Sanchez

CONTACT

[email protected]

+33 3 80 40 01 14

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

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

Acronym: FEM-COMB

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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