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

NCT06522620 | Recruiting

• 1 other identifier: Peng Liu-2024-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Posterior Femoral Cutaneous Nerve; Nerve Block; TKA; posterior lateral knee pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Postoperative night sleep time

  First night after surgery, second night after surgery

• Earliest time on the ground

  Within 48 hours of surgery

• Amount of remedial opioid use

  Within 48 hours of surgery

• Number of patient PCNA uses

  Within 48 hours of surgery

• Incidence rate of postoperative adverse outcomes

  Within 48 hours of surgery

Study Arms (2)

Sciatic saphenous nerve block group (Group S)

ACTIVE COMPARATOR

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

Procedure: Simple Sciatic and Saphenous Nerve Blocks

Combined posterior femoral cutaneous nerve block group (Group P)

EXPERIMENTAL

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

Interventions

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

Also known as: supragluteal approach sciatic nerve block

Combined posterior femoral cutaneous nerve block group (Group P)

Simple Sciatic and Saphenous Nerve Blocks 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

Also known as: subgluteal approach sciatic nerve block

Sciatic saphenous nerve block group (Group S)

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General hospital of Ningxia medical university

Yinchuan, Ningxia, 750004, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Xinli Ni, MD

CONTACT

13909586966; xinlini6@nyfy.com.cn

Peng Liu

CONTACT

15349487818; 1136969380@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 26, 2024
• Study Start: July 1, 2024
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)