Postoperative Pain, AcutePhase 4TKANCT07271849
Nalbuphine Timing Effects on Hemodynamics and Analgesia in Elderly Patients
A Phase 4 study testing Nalbuphine Hydrochloride injection was administered during anesthesia induction., Nalbuphine Hydrochloride injection was administered after cement implantation. and Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.) in people with Postoperative Pain, Acute and Hemodynamics, run by Qianfoshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Postoperative Pain, Acute, Hemodynamics, Total Knee Arthroplasty (TKA)
- What is being tested?
- Nalbuphine Hydrochloride injection was administered during anesthesia induction., Nalbuphine Hydrochloride injection was administered after cement implantation. and Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2025to 31 Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University,
Jinan, Shandong, 250000
Liang Guo, Ph.D, 86 170 9683 8266, 2330guoliang@163.com
About this study
Official title: Effects of Different Administration Timings of Nalbuphine on Hemodynamics and Postoperative Analgesia in Elderly Patients Undergoing Total Knee Arthroplasty
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.
Read the 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.
- Being tested
- 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.)
- Keywords
- Total Knee Arthroplasty (TKA), Postoperative Pain, Nalbuphine, Hemodynamics
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalbuphine Hydrochloride injection was administered during anesthesia induction.Drug
Also called Nalbuphine
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.
Nalbuphine Hydrochloride injection was administered after cement implantation.Drug
Also called Nalbuphine
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: 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. Receives: Other: Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 30 minutes postoperatively
Secondary outcomes (9)
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).
Measured: 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).
Heart rate refers to the number of heartbeats per minute
Measured: 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)
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.
Measured: 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
The cumulative Opioids consumption such as demerol,sufentanil,morphine
Measured: within 24 hours postoperatively:
the number of participants requiring rescue analgesia
The number of patients who required additional analgesics such as opioids(demerol,sufentanil,morphine)or non-steroid anti-inflammatory drugs(acetaminophen,diclofenac).
Measured: within 24 hours postoperatively
Incidence of adverse reactions within 24 hours postoperatively
(Postoperative nausea and vomiting)Nausea is defined as subjective,unpleasant sensation associated with awareness of the urge to vomit. Retching is defined as the laboured, spastic, rhythmic contraction of the respiratory muscles without expulsion of the gastric contents.Vomiting is defined as the forceful expulsion of gastric contents from the mouth.The adverse central nervous system (CNS) events(such as nightmares, hallucinations, dizziness, itchy skin) were recorded (yes/no).
Measured: within 24 hours postoperatively
The types and dosages of vasoactive drugs administered to patients during the perioperative period were recorded
If non-invasive blood pressure exceeded the patient's baseline value by 10%, urapidil hydrochloride injection was administered; if it was lower than the baseline by 10%, norepinephrine was administered. The types and dosages of vasoactive drugs used in each group were promptly documented.
Measured: at 30 minutes postoperatively
The surgical duration time
The surgical duration was defined as the period from the surgeon's initial skin incision to the completion of skin closure.
Measured: Immediately after surgery
The time of laryngeal mask airway (LMA) removal were recorded.
LMA removal was performed when the patient regained consciousness and maintained SpO₂ above 90% while breathing room air spontaneously for 10 minutes.
Measured: 10-15 minutes after the conclusion of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start28 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Guo, Qianfoshan Hospital
- Investigators
- Guo Liang, Ph.D, Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271849
- Sponsor's protocol ID
- YXLL-KY-2025(207)
- Acronym
- TKA
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Administration Timings of Nalbuphine on Hemodynamics and Postoperative Analgesia in Elderly Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07271849
- Acronym / sponsor ID
- TKA / YXLL-KY-2025(207)
- Keywords
- Total Knee Arthroplasty (TKA), Postoperative Pain, Nalbuphine, Hemodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group N0 | Experimental | Drug: Nalbuphine Hydrochloride injection was administered during anesthesia induction.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) |
| Group N1 | Experimental | Drug: Nalbuphine Hydrochloride injection was administered after cement implantation.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). |
| Control Group (Group C) | Active comparator | Other: Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.)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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nalbuphine Hydrochloride injection was administered during anesthesia induction.Also: NalbuphineA 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 | Group N0 |
| Nalbuphine Hydrochloride injection was administered after cement implantation.Also: NalbuphineAfter 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. | Drug | Group N1 |
| 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. | Other | Control Group (Group C) |
Primary outcome
Visual Analog Scale (VAS) scores of participants at 30 minutes postoperatively.
Time frame: 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.
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guo Liang, Ph.D principal investigator
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nalbuphine Hydrochloride injection was administered during anesthesia induction., Nalbuphine Hydrochloride injection was administered after cement implantation. and Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.) in people with Postoperative Pain, Acute and Hemodynamics, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guo Liang, Ph.D (8617096838266, 2330guoliang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) scores of participants at 30 minutes postoperatively. (time frame: at 30 minutes postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.