Nalbuphine Timing Effects on Hemodynamics and Analgesia in Elderly Patients
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nalbuphine Hydrochloride injection was administered during anesthesia induction., Nalbuphine Hydrochloride injection was administered after cement implantation., Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.).
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Acute, Hemodynamics, Total Knee Arthroplasty (TKA). Basic parameters: 65 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Different Administration Timings of Nalbuphine on Hemodynamics and Postoperative Analgesia in Elderly Patients Undergoing Total Knee Arthroplasty
Overview
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.
Detailed description
Total knee arthroplasty (TKA) is a widely performed routine surgical procedure for treating end-stage osteoarthritis (OA) or rheumatoid arthritis, aiming to alleviate pain and improve the quality of life for participants . However, participants undergoing TKA frequently experience moderate to severe postoperative pain during the perioperative period, with some even suffering from extremely severe pain . Intense postoperative pain can lead to prolonged hospital stays, increased readmission rates, elevated opioid consumption, and associated complications such as nausea and vomiting. These factors diminish participant satisfaction and escalate healthcare costs . Consequently, effective postoperative pain management is crucial for promoting early recovery and improving participant outcomes.
During TKA, periarticular tissue dissection and osteotomy cause bleeding and traumatic inflammation. Techniques such as tourniquet application and controlled hypotension are commonly employed. However, tourniquet-induced ischemia-reperfusion injury and inappropriate controlled hypotension can result in cardiac and cerebral injury for participants. Therefore, maintaining hemodynamic stability, ensuring adequate cerebral perfusion, and achieving controlled blood pressure throughout the perioperative period are critical factors for participant prognosis .
Opioids remain the conventional medication for perioperative pain relief. While effective for analgesia, they are associated with adverse effects such as respiratory depression, postoperative nausea and vomiting (PONV), and pruritus. Nalbuphine, an opioid acting as a full κ-receptor agonist and partial μ-receptor antagonist, is considered to provide analgesic efficacy equivalent to morphine and is widely used for managing moderate to severe postoperative pain . Studies indicate that nalbuphine offers superior hemodynamic stability and analgesic effects compared to morphine across various surgical procedures. It not only alleviates postoperative pain but also demonstrates a lower incidence of PONV. Its analgesic and sedative properties are also considered safe for use in pediatric populations . Nevertheless, conclusive evidence regarding the analgesic and hemodynamic effects of nalbuphine in elderly participants undergoing knee arthroplasty during the perioperative period remains lacking.
Therefore, this study aims to investigate the impact of administering equivalent doses of nalbuphine at different perioperative time points on analgesia and hemodynamics in elderly participants undergoing total knee arthroplasty.
Interventions
- Drug Nalbuphine Hydrochloride injection was administered during anesthesia induction.
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. - Drug Nalbuphine Hydrochloride injection was administered after cement implantation.
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. - Other Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.)
Conventional induction and anesthesia was maintained were performed, with no intravenous nalbuphine administered for analgesia.
Primary outcome measures
- Visual Analog Scale (VAS) scores of participants at 30 minutes postoperatively. [Time frame: at 30 minutes postoperatively]
Secondary outcome measures (9)
- Hemodynamic parameters at various perioperative time points， Parameters include blood pressure, mean arterial pressure (MAP) [Time frame: 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). [Time frame: 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) [Time frame: 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 [Time frame: within 24 hours postoperatively:]
- the number of participants requiring rescue analgesia [Time frame: within 24 hours postoperatively]
- Incidence of adverse reactions within 24 hours postoperatively [Time frame: within 24 hours postoperatively]
- The types and dosages of vasoactive drugs administered to patients during the perioperative period were recorded [Time frame: at 30 minutes postoperatively]
- The surgical duration time [Time frame: Immediately after surgery]
- The time of laryngeal mask airway (LMA) removal were recorded. [Time frame: 10-15 minutes after the conclusion of the surgery.]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
China · 1 center
- Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University, — Jinan
Identifiers
NCT: NCT07271849 · YXLL-KY-2025(207)