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

NCT ID: NCT06522620

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-09-25

Brief Summary

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.

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sciatic saphenous nerve block group (Group S)

Postoperative analgesia using subgluteal approach sciatic nerve block + saphenous nerve block

Group Type: ACTIVE_COMPARATOR

Simple Sciatic and Saphenous Nerve Blocks

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve Block

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

supragluteal approach sciatic nerve block; subgluteal approach sciatic nerve block

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

General Hospital of Ningxia Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

General hospital of Ningxia medical university

Yinchuan, Ningxia, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinli Ni, MD

Role: CONTACT

xinlini6@nyfy.com.cn

13909586966

Peng Liu

Role: CONTACT

1136969380@qq.com

15349487818

Facility Contacts

xinli Ni, MD

Role: primary

xinlini6@nyfy.com.cn

86-0951-6743252

Other Identifiers

Peng Liu-2024-1

Identifier Type: -

Identifier Source: org_study_id