Combined Distal Femoral Nerve Block for Pain Control After Knee Replacement

N/ANot Yet RecruitingNCT07629388

Ramsay Générale de Santé240 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

240

Conditions

Pain After Total Knee Arthroplasty Pain Management

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Postoperative Opioid Consumption in post-anesthesia care unit (PACU).

Total amount of opioids consumed in the post-anesthesia care unit, converted into oral morphine equivalent.

Time frame: From arrival in PACU until discharge from PACU, on postoperative day 0.

Secondary Outcomes

Pain During Regional Anesthesia

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.

Time frame: During block administration on postoperative day 0.

Postoperative Pain in post-anesthesia care unit (PACU) and Ward

Pain intensity measured with a 10-point visual analog scale (VAS), in which 0 indicates no pain and 10 indicates maximal pain.

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).

Quadriceps Motor Strength

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.

Time frame: Postoperative day 0 in PACU and postoperative day 1.

Time to First Standing

Delay until first mobilization/first standing after surgery.

Time frame: Postoperative day 0.

Postoperative Nausea and Vomiting

Incidence of postoperative nausea and vomiting in post-anesthesia care unit (PACU).

Time frame: Postoperative day 0 in post-anesthesia care unit (PACU).

Oral Opioid Consumption on the Ward

Total oral opioid use during hospitalization, reported as oral morphine equivalent.

Time frame: Postoperative day 1 and until hospital discharge (up to 7 days).

Co-analgesic Consumption

Use of co-analgesics including nefopam, paracetamol, opium, and ketoprofen during hospitalization.

Time frame: Postoperative day 1 and until hospital discharge (up to 7 days).

Intraoperative Medication Use

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

Time frame: Intraoperative period on postoperative day 0.

Length of Hospital Stay

Duration of hospitalization after surgery.

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

Patient Satisfaction

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.