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

Effects of Different Administration Timings of Nalbuphine on Hemodynamics and Postoperative Analgesia in Elderly Patients Undergoing Total Knee Arthroplasty

We will test whether giving nalbuphine at different times during knee replacement helps control pain and stabilize blood pressure in people 65 and older.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 65 Years to 90 Years
• Sex: All
• Sponsor: Qianfoshan Hospital (other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07271849 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 65 or older undergoing unilateral total knee arthroplasty under general anesthesia with BMI 18–30, ASA I–III, normal mental status, and no contraindications to nalbuphine.

Not a fit: Patients with uncontrolled hypertension, severe respiratory disease, significant liver or kidney dysfunction, or who fall outside the specified age or BMI ranges are unlikely to be eligible or benefit from this protocol.

Why it matters

Potential benefit: If successful, timing nalbuphine appropriately could reduce pain and opioid use while improving blood pressure stability and cerebral perfusion during and after knee replacement in older patients.

How similar studies have performed: Prior clinical work shows nalbuphine provides effective postoperative analgesia with fewer mu-opioid side effects than morphine, but using specific timing to improve intraoperative hemodynamics in elderly TKA patients is relatively novel.

Eligibility criteria

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 this trial is running

Jinan, Shandong

• 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

Conditions: Postoperative Pain, Acute, Hemodynamics, Total Knee Arthroplasty, Postoperative Pain, Nalbuphine