Timing nalbuphine for pain relief and blood pressure control during knee replacement in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 interventional trial compares three approaches to perioperative nalbuphine use in elderly patients undergoing unilateral total knee arthroplasty under general anesthesia: nalbuphine at induction, nalbuphine after cement implantation, or standard care without nalbuphine. Investigators will monitor intraoperative hemodynamics, proxies for cerebral perfusion, postoperative pain scores, total opioid consumption, and opioid-related side effects such as nausea and vomiting. Eligible participants are adults aged 65 or older with BMI 18–30 and ASA physical status I–III who consent and meet laboratory criteria. The study aims to determine whether the timing of nalbuphine administration improves hemodynamic stability and reduces postoperative pain and opioid needs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All study participants voluntarily enrolled in the trial and provided written informed consent after being fully informed of the trial's purpose and significance
* Participants underwent unilateral total knee arthroplasty under general anesthesia
* Elderly participants (age ≥ 65 years), regardless of gender
* Body mass index (BMI) ranging from 18 kg/m² to 30 kg/m²
* Absence of psychiatric disorders, normal consciousness, and ability to communicate effectively
* American Society of Anesthesiologists (ASA) physical status classification I-III;
* No contraindications to the study medications

Exclusion Criteria:

* Study participants with uncontrolled or untreated hypertension (resting systolic/diastolic blood pressure \>180/100 mmHg)
* Individuals with severe respiratory diseases
* Subjects with abnormal liver or renal function (ALT and/or AST \>2.5 times the upper limit of normal, total bilirubin \>1.5 times the upper limit of normal, serum creatinine \>1.5 times the upper limit of normal)
* Individuals with a history of drug abuse, illicit drug use, or alcohol abuse, where alcohol abuse is defined as an average daily alcohol intake exceeding 2 units (1 unit = 360 mL of beer, 45 mL of 40% alcohol by volume spirits, or 150 mL of wine)

Where it's running

• Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University,
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Guo Liang, Ph.D — Qianfoshan Hospital
• Study coordinator: Guo Liang, Ph.D
• Email: 2330guoliang@163.com
• Phone: 8617096838266

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.