Nalbuphine Timing Effects on Hemodynamics and Analgesia in Elderly Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65-90
SponsorQianfoshan Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Nalbuphine Hydrochloride injection was administered during anesthesia induction.
DrugA 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.
Nalbuphine Hydrochloride injection was administered after cement implantation.
DrugAfter 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.
Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.)
Other interventionConventional induction and anesthesia was maintained were performed, with no intravenous nalbuphine administered for analgesia.
Treatment groups
162 Participants
are divided into 3 treatment groupsGroup A: Group N0Experimental treatment 1 intervention
Group B: Group N1Experimental treatment 1 intervention
Group C: Control Group (Group C)Active comparator 1 intervention
Trial outcomes
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.
Time frame
at 30 minutes postoperativelySecondary outcomes
1
Hemodynamic parameters at various perioperative time points， Parameters include blood pressure, mean arterial pressure (MAP)
Blood pressure is the lateral pressure exerted by blood on the walls of blood vessels during circulation, consisting of systolic pressure (when the heart contracts) and diastolic pressure (when the heart relaxes).
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).2
Hemodynamic parameters at various perioperative time points，heart rate (HR).
Heart rate refers to the number of heartbeats per minute
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).3
Postoperative pain assessment using the Visual Analog Scale (VAS)
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.
Time frame
after extubation, and at 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively.4
Requirement for rescue analgesic medication within 24 hours postoperatively
The cumulative Opioids consumption such as demerol,sufentanil,morphine
Time frame
within 24 hours postoperatively:Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov