Effect of Posterior Femoral Cutaneous Nerve Block on Postoperative Posterior Lateral Knee Analgesia in Patients With TKA

Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve Block for Postoperative Posterior Lateral Knee Analgesia in Patients With TKA: a Single-center, Prospective, Randomized Controlled Study

The aim of this study was to observe the effects of posterior femoral cutaneous nerve block combined with sciatic and saphenous nerve block compared with sciatic and saphenous nerve block alone on postoperative posterior side of the knee (popliteal fossa) pain and sleep quality in patients with TKA, and to further alleviate postoperative posterior side of the knee pain in patients with TKA and improve the quality of postoperative sleep.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Simple Sciatic and Saphenous Nerve Blocks; Procedure: Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve Block

Detailed Description

Total knee arthroplasty (TKA) is one of the most common surgical procedures worldwide. Although surgical and anesthesia techniques have become more mature, poor postoperative pain control after TKA is still an important problem for patients and clinicians. Peripheral nerve blocks (PNBs) have been widely used in clinical practice for postoperative analgesia after TKA.The combinations of PNBs available for postoperative analgesia after TKA include femoral/obturator , femoral/sciatic/obturator, lumbar plexus/sciatic, and femoral/sciatic, and the combination of PNBs has been shown to be effective for postoperative analgesia after TKA in a study of TKA. Meta-analysis of postoperative pain management modalities, it was concluded that blocking multiple nerves was superior to blocking any of the nerves, periarticular infiltration, or epidural analgesia, while the combination of femoral and sciatic nerve block was overall the best postoperative analgesia for TKA. The investigators found that even in patients who underwent a single combined sciatic nerve and saphenous nerve block + continuous femoral nerve block, poor quality of sleep and pain in the affected limb were still common in the postoperative period, and the complaints of pain in the affected limb were mainly centered on the posterior side of the knee (popliteal fossa) and the margins. The area where the patient's complaints were concentrated was within the range of superficial skin sensation innervated by the posterior femoral cutaneous nerve, which is a pure sensory nerve that originates from the lumbosacral plexus, descends through the lower border of the pectineus muscle, and sends out three branches, among which the posterior femoral cutaneous branch innervates superficial sensation in the posterior thigh and popliteal fossa, and the innervation of the posterior femoral cutaneous nerve is not only limited to the posterior thigh and popliteal fossa, but may also extend to the ankle joint. even extend to the ankle joint. The investigators hypothesized that a posterior femoral cutaneous nerve block could reduce pain in the posterior side of the knee in patients after TKA, and there is a theoretically feasible anatomical basis for this hypothesis. Pain is one of the most important factors affecting the quality of sleep in patients, and pain relief may potentially improve the quality and prolong the duration of sleep in patients, thus providing the conditions for comfortable medical treatment and a good prognosis.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinli Ni, MD; Phone Number: 13909586966; Email: xinlini6@nyfy.com.cn
• Study Contact Backup: Name: Peng Liu; Phone Number: 15349487818; Email: 1136969380@qq.com

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • Recruiting
      • General Hospital of Ningxia Medical University
      • Contact: Xinli Ni, MD; Phone Number: 86-0951-6743252; Email: xinlini6@nyfy.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients who are >45 years of age; intended to undergo elective first TKA under general anesthesia
2. ASA grade II-III.
3. Agreed to participate in this study and signed the informed consent form.
4. BMI less than 28Kg/m2.

Exclusion Criteria:

1. Patients who refuse to participate in the trial
2. Preoperative inability to communicate due to speech and hearing impairment, etc.
3. History of allergy to local anesthetics or opioids
4. Contraindications to nerve block operation.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sciatic saphenous nerve block group (Group S); Postoperative analgesia using subgluteal approach sciatic nerve block + saphenous nerve block	Procedure: Simple Sciatic and Saphenous Nerve Blocks; All nerve blocks were performed under ultrasound guidance，single subgluteal approach sciatic nerve block using a nerve stimulator, with 25 ml of drug injected around the sciatic nerve, followed by a retractile canal saphenous nerve block with 15 ml of drug injection; Other Names: subgluteal approach sciatic nerve block
Experimental: Combined posterior femoral cutaneous nerve block group (Group P); Postoperative analgesia using supragluteal approach sciatic nerve block + posterior femoral cutaneous nerve block + saphenous nerve block	Procedure: Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve Block; All nerve blocks were performed under ultrasound guidance，single supragluteal approach sciatic nerve block using a nerve stimulator, 20 ml of drug was injected around the sciatic nerve, the extent of drug diffusion was observed, the needle tip was turned into the deep surface of the gluteus maximus muscle below the deep gluteal artery and 5 ml of drug was injected, followed by a retractile canal saphenous nerve block injected with 15 ml of drug, and the difference in sensation of the posterior thighs of the bilateral thighs was measured after 15 min to ensure posterior femoral cutaneous nerve were blocked; Other Names: supragluteal approach sciatic nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative anteroposterior and posterior knee Visual Analogue Scale scores (passive motion/resting)	The level of pain at the knee surface incision and on the posterior side of the knee at rest and motion was asked and recorded using the Visual Analogue Scale scores at postoperative hour 1 (before the patient left the PACU), postoperative hour 6, postoperative hour 24, and postoperative hour 48, respectively (0 for no pain and 10 for the most severe pain imaginable)	postoperative hour 1，postoperative hour 6，postoperative hour 24，postoperative hour 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative night sleep time	Use of exercise bracelets to record actual hours of patient sleep	First night after surgery, second night after surgery
Earliest time on the ground	Length of time between the end of surgery and the patient's active movement off the floor	Within 48 hours of surgery
Amount of remedial opioid use	Total remedially applied opioids within 48 hours of surgery	Within 48 hours of surgery
Number of patient PCNA uses	Number of times a patient presses the PCNA in the 48 hours postoperatively	Within 48 hours of surgery
Incidence rate of postoperative adverse outcomes	Including （1）the number of people who experienced soreness in the affected limb, （2）the number of people who had nausea and the number of times they vomited,（3） the number of people who had the femoral nerve recanalized, （4）the number of people who had thrombosis in the first 48 hours after the operation, （5）and the number of people who had urinary retention.	Within 48 hours of surgery
Hip Knee Ankle	Comparison of the change in HKA angle on lower extremity X-ray film in patients during the preoperative week versus the change in HKA angle on lower extremity X-ray film during the postoperative week	within the preoperative week versus the postoperative week

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): September 25, 2024
• Study Completion (Estimated): September 25, 2024

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Nerve Block; TKA; Posterior Femoral Cutaneous Nerve; posterior lateral knee pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Peng Liu-2024-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No