Effect of Bupivacaine Liposome Injection on Muscle Strength After Total Knee Arthroplasty

NCT07616102 | Not Yet Recruiting DMC

• 1 other identifier: Qiaojiang Shen-2026-03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study employs a randomized controlled trial to investigate whether bupivacaine liposome injection for adductor canal block can effectively improve lower limb muscle strength after total knee arthroplasty.

Conditions

TKA; Muscle Strength

Keywords

Bupivacaine Liposome; Adductor Canal Block; TKA; Muscle Strength

Outcome Measures

Primary Outcomes (1)

• Quadriceps Muscle Strength

  The Maximum Voluntary Isometric Contraction (MVIC) test is used to assess quadriceps strength. The tester holds a handheld dynamometer. The patient sits on the bed with legs hanging naturally, and the knee is flexed to 60°. The patient is instructed to slowly exert force to extend the knee forward. As the patient exerts force, the tester applies an equal and opposite counterforce with the dynamometer to maintain the position and angle of the lower leg. The patient sustains maximum effort for 3-5 seconds, and the peak value displayed on the dynamometer is recorded as the result for that trial. Each leg is tested 2-3 times, with a 60-90 second rest between trials to prevent muscle fatigue from affecting the results. The average value is recorded as the final outcome. The unit of measurement is Newtons (N).

  24 hours after surgery

Secondary Outcomes (6)

• Quadriceps muscle strength at other time points

  48 hours after surgery

• Numeric Rating Scale (NRS) Score

  24 and 48 hours after surgery

• Quadriceps muscle strength grade

  24 and 48 hours after surgery

• Knee Joint Range of Motion

  24 and 48 hours after surgery

• Total Opioid Consumption

  From the end of the surgery until 72 hours postoperatively

Study Arms (2)

a single-injection adductor canal block

EXPERIMENTAL

An ultrasound-guided adductor canal block is performed via the conventional adductor canal approach. Under ultrasound guidance, 20 milliliters of 1.33% bupivacaine liposome is injected into the adductor canal.

Procedure: a single-injection adductor canal block

continuous femoral nerve block

ACTIVE COMPARATOR

An ultrasound-guided perineural sheath block of the femoral nerve is performed via the conventional femoral nerve approach. A femoral nerve catheter is then placed and connected to an analgesia pump containing 150 milliliters of 0.20% ropivacaine.

Procedure: continuous femoral nerve block

Interventions

a single-injection adductor canal block PROCEDURE

An ultrasound-guided adductor canal block is performed via the conventional adductor canal approach. Under ultrasound guidance, 20 milliliters of 1.33% bupivacaine liposome is injected into the adductor canal.

a single-injection adductor canal block

continuous femoral nerve block PROCEDURE

An ultrasound-guided perineural sheath block of the femoral nerve is performed via the conventional femoral nerve approach. A femoral nerve catheter is then placed and connected to an analgesia pump containing 150 milliliters of 0.20% ropivacaine.

continuous femoral nerve block

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 60-75 years scheduled for elective TKA;
• ASA physical status classification II-III;
• BMI 18-30 kg/m²;
• Agreement to participate in this study and provision of signed informed consent.

You may not qualify if:

• Individuals with communication barriers such as language or hearing impairments;
• Patients with contraindications to nerve blocks;
• Severe systemic diseases, such as severe renal disease (estimated glomerular filtration rate below 50 mL/min), cardiac disease (congestive heart failure New York Heart Association Class III to IV), or severe hepatic disease defined as a current or past diagnosis of acute/subacute hepatic necrosis, acute liver failure, chronic liver disease, liver abscess, hepatic coma, or hepatorenal syndrome;
• History of long-term opioid use (defined as daily or nearly daily opioid use within the past 3 months).

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General hospital of Ningxia medical university

Yinchuan, Ningxia, China

Location

Study Officials

• Xinli Ni

  General Hospital of Ningxia Medical University

  STUDY CHAIR

Central Study Contacts

Xin li Ni, MD

CONTACT

13909586966; xinlii6@nyfy.com.cn

Qiaojiang Shen

CONTACT

17829917323; 2832394521@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: March 27, 2026
• First Posted: May 29, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 3, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)