Effects of Different Administration Timings of Nalbuphine on Hemodynamics and Postoperative Analgesia in Elderly Patients Undergoing Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) scores of participants at 30 minutes postoperatively.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Group N0
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)
干预措施: Nalbuphine Hydrochloride injection was administered during anesthesia induction. (Drug)
Group N1
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).
干预措施: Nalbuphine Hydrochloride injection was administered after cement implantation. (Drug)
Control Group (Group C)
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.
干预措施: Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.) (Other)
结局指标
主要结局
Visual Analog Scale (VAS) scores of participants at 30 minutes postoperatively.
时间窗: 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.
次要结局
- 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:)
- 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).)
- the number of participants requiring rescue analgesia(within 24 hours postoperatively)
- Incidence of adverse reactions within 24 hours postoperatively(within 24 hours postoperatively)
- The types and dosages of vasoactive drugs administered to patients during the perioperative period were recorded(at 30 minutes postoperatively)
- The surgical duration time(Immediately after surgery)
- The time of laryngeal mask airway (LMA) removal were recorded.(10-15 minutes after the conclusion of the surgery.)
研究者
Liang Guo
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Qianfoshan Hospital