Nalbuphine Timing Effects on Hemodynamics and Analgesia in Elderly Patients

NCT07271849 | Recruiting Phase 4

• 1 other identifier: YXLL-KY-2025(207)
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain, Acute; Hemodynamics; Total Knee Arthroplasty (TKA)

Keywords

Total Knee Arthroplasty (TKA); Postoperative Pain; Nalbuphine; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) scores of participants at 30 minutes postoperatively.

  VAS (Visual Analogue Scale) is a tool used to quantify subjective pain intensity via a visual linear scale. Its core design involves a 10 cm straight line, with the left end marked "no pain" (0 points) and the right end "severe pain" (10 points). Patients mark a position on the line based on their perceived pain, and clinicians convert this to a 0-10 pain score by measuring the distance (in millimeters) from the marked point to the left end.

  at 30 minutes postoperatively

Secondary Outcomes (9)

• Hemodynamic parameters at various perioperative time points， Parameters include blood pressure, mean arterial pressure (MAP)

  T0 (during anesthesia induction), T1 (5 minutes after induction ), T2 (before cement placement), T3 (5 minutes after cement placement), T4 (15minutes post-anesthesia ), T5 (15 minutes in the Post-Anesthesia Care Unit, PACU), and T6 (30 minutes in PACU).

• Hemodynamic parameters at various perioperative time points，heart rate (HR).

  T0 (during anesthesia induction), T1 (5 minutes after induction ), T2 (before cement placement), T3 (5 minutes after cement placement), T4 (15minutes post-anesthesia ), T5 (15 minutes in the Post-Anesthesia Care Unit, PACU), and T6 (30 minutes in PACU).

• Postoperative pain assessment using the Visual Analog Scale (VAS)

  after extubation, and at 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively.

• Requirement for rescue analgesic medication within 24 hours postoperatively

  within 24 hours postoperatively:

• the number of participants requiring rescue analgesia

  within 24 hours postoperatively

Study Arms (3)

Group N0

EXPERIMENTAL

Anesthesia Induction: Dexamethasone (10 mg), midazolam (0.01-0.05 mg/kg), sufentanil (0.2-0.4 μg/kg), etomidate (0.15-0.3 mg/kg), and atracurium (0.3-0.6 mg/kg) were administered intravenously. After complete neuromuscular blockade was achieved, a laryngeal mask airway was inserted (size selected according to body weight).Intravenous nalbuphine (0.2 mg/kg) was administered during anesthesia induction. Anesthesia was maintained by continuous intravenous infusion of propofol (4-12 mg/kg/h) and remifentanil (0.15-0.3 μg/kg/min)

Drug: Nalbuphine Hydrochloride injection was administered during anesthesia induction.

Group N1

EXPERIMENTAL

Anesthesia Induction: Dexamethasone (10 mg), midazolam (0.01-0.05 mg/kg), sufentanil (0.2-0.4 μg/kg), etomidate (0.15-0.3 mg/kg), and atracurium (0.3-0.6 mg/kg) were administered intravenously. After complete neuromuscular blockade was achieved, a laryngeal mask airway was inserted (size selected according to body weight).Intravenous nalbuphine (0.2 mg/kg) was administered after cement implantation. Anesthesia was maintained by continuous intravenous infusion of propofol (4-12 mg/kg/h) and remifentanil (0.15-0.3 μg/kg/min).

Drug: Nalbuphine Hydrochloride injection was administered after cement implantation.

Control Group (Group C)

ACTIVE COMPARATOR

Anesthesia Induction: Dexamethasone (10 mg), midazolam (0.01-0.05 mg/kg), sufentanil (0.2-0.4 μg/kg), etomidate (0.15-0.3 mg/kg), and atracurium (0.3-0.6 mg/kg) were administered intravenously. After complete neuromuscular blockade was achieved, a laryngeal mask airway was inserted Conventional induction and anesthesia was maintained by continuous intravenous infusion of propofol (4-12 mg/kg/h) and remifentanil (0.15-0.3 μg/kg/min) were performed, with no intravenous nalbuphine administered for analgesia.

Other: Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.)

Interventions

Nalbuphine Hydrochloride injection was administered during anesthesia induction. DRUG

A single intravenous injection of Nalbuphine Hydrochloride Injection (dose specified, e.g., 0.2 mg/kg) was administered to the patient during general anesthesia induction. Neither the control group nor intervention group N1 received the drug during this stage.The remainder of the anesthesia protocol was consistent across all three groups.

Also known as: Nalbuphine

Group N0

Nalbuphine Hydrochloride injection was administered after cement implantation. DRUG

After intraoperative prosthesis placement, a single intravenous injection of nalbuphine hydrochloride injection (0.2 mg/kg), identical to that in Intervention Group N0) was administered. Neither the control group nor Intervention Group N0 received medication at this timing. All other anesthesia management procedures were standardized.

Also known as: Nalbuphine

Group N1

Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.) OTHER

Conventional induction and anesthesia was maintained were performed, with no intravenous nalbuphine administered for analgesia.

Control Group (Group C)

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University,

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Nalbuphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Guo Liang, Ph.D

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guo Liang, Ph.D

CONTACT

8617096838266; 2330guoliang@163.com

Deng Shiyuan, master

CONTACT

8613791127650; 13791127650@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 9, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

CN (1)