NCT07271849 Nalbuphine Timing Effects on Hemodynamics and Analgesia in Elderly Patients
| NCT ID | NCT07271849 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Qianfoshan Hospital |
| Condition | Postoperative Pain, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2025-10-28 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 162 participants in total. It began in 2025-10-28 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In total knee arthroplasty (TKA), the use of a tourniquet and controlled hypotension is common. However, ischemia-reperfusion injury induced by the tourniquet and inappropriate controlled hypotension can lead to cardiac and cerebral damage in patients. Consequently, maintaining hemodynamic stability, ensuring adequate cerebral perfusion, and achieving controlled blood pressure during the perioperative period are critical factors influencing patient outcomes. Postoperatively, patients typically experience moderate to severe pain. Severe postoperative pain can result in prolonged hospital stays, increased readmission rates, elevated opioid consumption, and associated nausea and vomiting. Therefore, exploring effective multimodal postoperative pain management strategies is essential. Nalbuphine, an opioid analgesic acting as a full kappa-receptor agonist and a partial mu-receptor antagonist, is considered to provide analgesic efficacy equivalent to morphine while potentially offering advantages in maintaining hemodynamic stability. This study aims to investigate the effects of administering equivalent doses of nalbuphine at different perioperative time points on analgesia and hemodynamics in elderly patients undergoing knee arthroplasty.
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)
Contact & Investigator
Guo Liang, Ph.D
PRINCIPAL INVESTIGATOR
Qianfoshan Hospital
Frequently Asked Questions
Who can join the NCT07271849 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 90 Years, studying Postoperative Pain, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07271849 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07271849 currently recruiting?
Yes, NCT07271849 is actively recruiting participants. Contact the research team at 2330guoliang@163.com for enrollment information.
Where is the NCT07271849 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT07271849 clinical trial?
NCT07271849 is sponsored by Qianfoshan Hospital. The principal investigator is Guo Liang, Ph.D at Qianfoshan Hospital. The trial plans to enroll 162 participants.