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Esmolol to Reduce Severe Pain After Nerve Block in Knee Replacement Patients

Effect of Intraoperative Intravenous Esmolol Infusion as an Adjunct to Fascia Iliaca Compartment Block on Rebound Pain After Peripheral Nerve Block in Patients Undergoing Total Knee Arthroplasty or Unicompartmental Knee Arthroplasty: A Randomized Placebo-Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129126
Enrollment
Unknown
Registered
2026-07-31
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rebound Pain After Peripheral Nerve Block

Interventions

Experimental group:Intravenous infusion of esmolol will be initiated 5 minutes before skin incision and maintained at 10 µg/kg/min until the completion of surgical skin closure.
Control group:Intraoperative intravenous infusion of an equal volume of 0.9% normal saline (placebo control)

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18–85 years, with no gender restriction; 2. Body mass index (BMI) between 18.5 and 31.9; 3. Patients with American Society of Anesthesiologists (ASA) physical status classification I–III; 4. Patients scheduled for elective unilateral total knee arthroplasty (TKA) or unicompartmental knee arthroplasty (UKA): (1) Significant knee pain affecting daily activities with limited painless walking distance (<500 meters); (2) Poor response to conservative treatment; (3) Imaging findings showing significant knee joint degeneration or structural damage; 5. Patients diagnosed with at least one of the following conditions: Knee osteoarthritis; Rheumatoid arthritis; Traumatic arthritis; Primary or secondary osteonecrosis of the knee; 6. Patients who voluntarily participate in the study and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.General conditions and contraindications to esmolol: (1) Patients with known hypersensitivity to esmolol or other ß-adrenergic blockers; (2) Severe bronchial asthma, acute exacerbation of chronic obstructive pulmonary disease; (3) Sinus bradycardia (heart rate 100 beats/min); (7) Severe hepatic or renal dysfunction (e.g., Child–Pugh class C liver disease or creatinine clearance < 35 mL/min); (8) Patients receiving long-term treatment with ß-blockers, a2-adrenergic agonists, or other potent heart rate-controlling medications that may interfere with intraoperative hemodynamic management or evaluation of rebound pain. 2.Contraindications to peripheral nerve block: (1) Patients with local infection at the puncture site, sepsis, severe coagulation disorders, or those receiving anticoagulant/antiplatelet therapy that has not been discontinued for an appropriate safety interval; (2) Patients with anatomical abnormalities, previous surgery, or trauma resulting in altered fascia iliaca compartment anatomy, making standardized fascia iliaca compartment block technically infeasible. 3.Surgery- and analgesia-related exclusions: Patients with a history of previous surgery on the ipsilateral knee; intraoperative conversion of the planned surgical procedure; refusal to use patient-controlled analgesia (PCA); inability to cooperate with postoperative pain assessment; or inability to undergo bispectral index (BIS) monitoring. 4.Follow-up-related exclusions: Patients with severe psychiatric disorders, cognitive impairment, or communication difficulties that may affect pain assessment or follow-up, including uncontrolled schizophrenia, severe depression, or other conditions considered by investigators to impair study participation. 5.Other exclusions: Patients with a history of chronic pain or long-term opioid use; pregnant or breastfeeding women; and patients who are concurrently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
incidence of rebound pain after peripheral nerve block;

Secondary

MeasureTime frame
Time to first request for rescue analgesia;Area under the curve of numerical rating scale (NRS) pain scores over time;Total perioperative opioid consumption, expressed in morphine milligram equivalents (MME);Sensory/motor block duration;Adverse Events;

Countries

China

Contacts

Public ContactLiangcheng Zhang

Fujian Medical University Union Hospital

zhanglc6@163.com+86 591 83357896

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026