Pain After Abdominal SurgeryPhase 3NCT07872826
A Clinical Trial Evaluating the Efficacy and Safety of Local Infiltration of RF16001 for Injection for Analgesia After Total Hip Arthroplasty in China
A Phase 3 study testing RF16001 for injection, Ropivacaine hydrochloride injection and 0.9% sodium chloride injection in people with Pain After Abdominal Surgery, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
A multicenter, randomized, double-blind, placebo-positive, parallel-controlled, phase Ⅲ clinical trial was conducted to investigate the efficacy and safety of RF16001 local infiltration for analgesia after total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain After Abdominal Surgery
- What is being tested?
- RF16001 for injection, Ropivacaine hydrochloride injection and 0.9% sodium chloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2026to 31 Oct 2027
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18-80 years old (including boundary value), regardless of gender;
- Unilateral total hip arthroplasty was planned under general anesthesia;
- American Society of Anesthesiologists (ASA) grade I-III;
- Male weight >=50.0kg, female weight >=45.0kg, and 18.0 kg/m2 <= body mass index (BMI) <= 32.0 kg/m2;
- Understand the nature, significance, possible benefits, possible inconvenience and potential risks of the trial in detail before the trial, understand the research procedures, and sign the informed consent form in person;
- The participants could understand the research process and the use of various scales involved in this study, communicate well with the researchers, and complete the study in accordance with the research regulations.
Who cannot join
- Had undergone ipsilateral hip surgery within 1 year before randomization, had undergone contralateral hip surgery within 3 months before randomization, and planned unilateral hip revision surgery;
- Skin infection, ulceration, or scar constitution around the planned surgical incision, and the investigator decided that it was not suitable to participate in the trial;
- A history of severe or refractory postoperative nausea or vomiting;
- History of myocardial infarction, unstable angina pectoris, severe arrhythmia such as atrioventricular block degree II or above, and cardiac insufficiency within the past year or currently; And not suitable to participate in the trial according to the investigator's judgment;
- A history of ischemic stroke (except lacunar infarction with no additional safety risk) or transient ischemic attack within the previous year or currently, a history of psychiatric disorders (such as schizophrenia, depression, etc.), cognitive impairment, or epilepsy as judged by the investigator to be ineligible to participate in the trial; Or any other central nervous system or cerebrovascular disease or medical history that was deemed by the investigator to be ineligible for participation in the trial;
- Patients who underwent total hip arthroplasty due to developmental dysplasia of the hip ⅲ-IV (Crowe classification in the Appendix), femoral neck fracture and/or intertrochanteric fracture, proximal femur or acetabular tumor and were judged by the investigator to be ineligible for the study;
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- Combined with other pain conditions that may confuse the evaluation of postoperative pain by the investigator, and was not suitable for participating in the study by the investigator; Patients who planned to undergo surgery at other sites during the study period;
- Patients with known history of anesthesia accident or any component of the investigational drug, protocol-defined intraoperative medication, allergy or contraindication to rescue drugs and similar drugs, past history and/or family history of malignant high fever;
- Use of any of the following drugs before randomization, except those permitted under the protocol: 1) within the 5 half-lives before randomization (subject to the actual drug instructions, if the half-life is unknown, it will be eluted according to 48h), including but not limited to: Class III antiarrhythmic drugs, glucocorticoids (intravenous or intra-joint), sedative-hypnotic agents, anxiolytic agents, antidepressant agents, strong CYP1A2 enzyme inhibitors (e.g., ciprofloxacin, enoxacin, eparylestradiol, fluvoxamine), strong CYP3A4 enzyme inhibitors (e.g., voriconazole, ketoconazole, ritonavir, clarithromycin), and sedative agents as specified in the protocol Except for prescribed use), analgesics (any opioids, non-opioids, local anesthetics (except for examination and intraoperative puncture and intubation), etc. Except if used in accordance with programme provisions); 2) successful use of Chinese herbal medicine with clear analgesic effects assessed by investigators from 7 days before signing ICF to randomization; 3) use of central alpha-adrenergic agonists (e.g., clonidine), anticonvulsants (e.g., pregabalin, gabapentin) within 14 days before randomization;
- QTc > 450ms in men and QTc > 470ms in women during the screening period; Or patients with pulse < 50 beats/min or pulse > 100 beats/min (excluding abnormal pulse before admission to the operating room), or patients with refractory hypertension (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg after treatment with 3 different types of antihypertensive drugs during screening, excluding abnormal blood pressure before admission to the operating room), According to the investigator's judgment, the abnormality has clinical significance.
- The following laboratory abnormalities during screening: 1) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 times upper limit of normal (ULN) and/or total bilirubin (TBIL) > 1.5 times ULN; 2) blood urea nitrogen (BUN) and/or serum creatinine (Cre) > 1.5 times upper limit of normal (ULN); 3) random blood glucose > 11.1mmol/L or glycated hemoglobin A1c > 8% in diabetic patients; 4) Prothrombin time (PT) > upper limit of normal +3s and/or activated partial thromboplastin time (APTT) > upper limit of normal +10s; 5) hemoglobin (Hb) < 80g/L; Or platelet count < 80% lower limit of normal;
- Pregnant or lactating women; Trial participants of childbearing potential and their partners were unwilling to use contraception throughout the study; Or planned pregnancy within 3 months after the end of the study (including male trial participants);
- A history of drug abuse and alcohol abuse within 1 year before using the investigational drug; Heavy drinking is defined as consuming more than 14 standard units of alcohol per week (1 standard unit containing 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); History of psychotropic drugs and narcotic drugs abuse;
- Participants who participated in any clinical trial as a trial participant within 3 months before randomization (received investigational drug), except those who failed screening and did not receive any treatment;
- Any other factors considered by the investigator to preclude participation in the trial.
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
The Third Xiangya Hospital of Central South University, Changsha, hunan
Changsha
About this study
Official title: To Evaluate the Efficacy and Safety of Local Infiltration of RF16001 for Injection for Analgesia After Total Hip Arthroplasty (THA) in a Multicenter, Randomized, Double-blind, Parallel, Positive and Placebo-controlled Phase Ⅲ Clinical Trial
A multicenter, randomized, double-blind, placebo-positive, parallel-controlled, phase Ⅲ clinical trial was conducted to investigate the efficacy and safety of RF16001 local infiltration for analgesia after total hip arthroplasty. The primary objective was to evaluate the effectiveness of local infiltration of RF16001 for injection for postoperative analgesia after total hip arthroplasty. The secondary objective was to evaluate the safety of local infiltration of RF16001 for injection for analgesia after total hip arthroplasty.
- Conditions
- Pain After Abdominal Surgery
- Being tested
- RF16001 for injection, Ropivacaine hydrochloride injection, 0.9% sodium chloride injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF16001 for injectionDrug
Before the surgical incision was closed, 30ml of 1.43% RF16001 for injection was administered by local infiltration around the incision by an unblinded physician
Ropivacaine hydrochloride injectionDrug
Before the surgical incision was closed, an unblinded physician administered 30ml 0.5% ropivacaine hydrochloride injection by local infiltration around the incision
0.9% sodium chloride injectionDrug
Before the surgical incision was closed, an unblinded physician administered 30ml 0.9% sodium chloride injection by local infiltration around the incision
| Study group | Role | What they receive |
|---|---|---|
| RF16001 group | Experimental | Before the surgical incision was closed, 30ml of 1.43% RF16001 for injection was administered by local infiltration around the incision by an unblinded physician Receives: Drug: RF16001 for injection |
| Ropivacaine group | Active comparator | Before the surgical incision was closed, 30ml of 0.5% ropivacaine was administered by a local infiltration around the incision by an unblinded physician Receives: Drug: Ropivacaine hydrochloride injection |
| Placebo control group | Placebo comparator | Before the surgical incision was closed, an unblinded physician administered 30ml 0.9% sodium chloride injection by local infiltration around the incision Receives: Drug: 0.9% sodium chloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC) of the pain intensity-time during 0-72h at rest
Area under the resting pain intensity time curve (AUC0-72h) during 0-72 hours after administration. The pain intensity was evaluated using the 11-point numerical rating scale (NRS; where 0 no pain and 10 worst possible pain).
Measured: From administration until 72 hours after administration
Secondary outcomes (8)
Area under the pain intensity time curve at rest
The area under the pain intensity time curve ( AUC0-24h, AUC24-48h, AUC48-72h) in resting state during 0-24h, 24-48h, and 48-72h after the completion of administration. The pain intensity was evaluated using the 11-point numerical rating scale (NRS; where 0 no pain and 10 worst possible pain).
Measured: From administration until 24 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration
Area under the pain intensity time curve during exercise
Area under the pain intensity time curve (AUC0-24h, AUC24-48h, AUC48-72h, AUC0-72h,) during exercise during 0-24h, 24-48h, 48-72h and 0-72h after the completion of administration. The pain intensity was evaluated using the 11-point numerical rating scale (NRS; where 0 no pain and 10 worst possible pain).
Measured: From the time of administration to 24 hours and 72 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration
Cumulative use of rescue analgesics during each period
Cumulative amount of rescue analgesics used during 0-24h, 24-48h, 48-72h, and 0-72h after completion of administration.
Measured: From the time of administration to 24 hours, 48 hours, 72 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration
The number of rescue analgesia in each period
The cumulative number of rescue analgesics used during 0-24h, 24-48h, 48-72h, and 0-72h after completion of administration
Measured: From the time of administration to 24 hours, 48 hours, 72 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration
Time of first morphine rescue analgesia
The time from the completion of administration to the first morphine rescue analgesic treatment
Measured: From administration until 72 hours after administration
Proportion of rescue analgesia in each period
Proportion of participants who used rescue analgesics within 0-24h, 24-48h, 48-72h, and 0-72h after completion of administration.
Measured: From the time of administration to 24 hours, 48 hours, 72 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration
Trial participant satisfaction and investigator satisfaction
Satisfaction was assessed using a Likert scale (comprising five dimensions: dissatisfied, neutral, satisfied, very satisfied, and extremely satisfied).
Measured: From administration until 72 hours after administration
Incidence of adverse events
Measured: From the time of administration to day 7 after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Natural Science Foundation of Hunan Province
- Responsible party
- Principal investigator, Yingyong Zhou,MD,PhD, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872826
- Sponsor's protocol ID
- RF-16001a-301
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of Local Infiltration of RF16001 for Injection for Analgesia After Total Hip Arthroplasty (THA) in a Multicenter, Randomized, Double-blind, Parallel, Positive and Placebo-controlled Phase Ⅲ Clinical Trial
- ClinicalTrials.gov ID
- NCT07872826
- Acronym / sponsor ID
- RF-16001a-301
- Conditions
- Pain After Abdominal Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Natural Science Foundation of Hunan Province
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 14 Oct 2026 (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.
A multicenter, randomized, double-blind, placebo-positive, parallel-controlled, phase Ⅲ clinical trial was conducted to investigate the efficacy and safety of RF16001 local infiltration for analgesia after total hip arthroplasty. The primary objective was to evaluate the effectiveness of local infiltration of RF16001 for injection for postoperative analgesia after total hip arthroplasty. The secondary objective was to evaluate the safety of local infiltration of RF16001 for injection for analgesia after total hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RF16001 group | Experimental | Drug: RF16001 for injectionBefore the surgical incision was closed, 30ml of 1.43% RF16001 for injection was administered by local infiltration around the incision by an unblinded physician |
| Ropivacaine group | Active comparator | Drug: Ropivacaine hydrochloride injectionBefore the surgical incision was closed, 30ml of 0.5% ropivacaine was administered by a local infiltration around the incision by an unblinded physician |
| Placebo control group | Placebo comparator | Drug: 0.9% sodium chloride injectionBefore the surgical incision was closed, an unblinded physician administered 30ml 0.9% sodium chloride injection by local infiltration around the incision |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of 18-80 years old (including boundary value), regardless of gender;
- Unilateral total hip arthroplasty was planned under general anesthesia;
- American Society of Anesthesiologists (ASA) grade I-III;
- Male weight >=50.0kg, female weight >=45.0kg, and 18.0 kg/m2 <= body mass index (BMI) <= 32.0 kg/m2;
- Understand the nature, significance, possible benefits, possible inconvenience and potential risks of the trial in detail before the trial, understand the research procedures, and sign the informed consent form in person;
Key exclusion criteria (15 listed)
- Had undergone ipsilateral hip surgery within 1 year before randomization, had undergone contralateral hip surgery within 3 months before randomization, and planned unilateral hip revision surgery;
- Skin infection, ulceration, or scar constitution around the planned surgical incision, and the investigator decided that it was not suitable to participate in the trial;
- A history of severe or refractory postoperative nausea or vomiting;
- History of myocardial infarction, unstable angina pectoris, severe arrhythmia such as atrioventricular block degree II or above, and cardiac insufficiency within the past year or currently; And not suitable to participate in the trial according to the investigator's judgment;
- A history of ischemic stroke (except lacunar infarction with no additional safety risk) or transient ischemic attack within the previous year or currently, a history of psychiatric disorders (such as schizophrenia, depression, etc.), cognitive impairment, or epilepsy as judged by the investigator to be ineligible to participate in the trial; Or any other central nervous system or cerebrovascular disease or medical history that was deemed by the investigator to be ineligible for participation in the trial;
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 |
|---|---|---|
| RF16001 for injectionBefore the surgical incision was closed, 30ml of 1.43% RF16001 for injection was administered by local infiltration around the incision by an unblinded physician | Drug | RF16001 group |
| Ropivacaine hydrochloride injectionBefore the surgical incision was closed, an unblinded physician administered 30ml 0.5% ropivacaine hydrochloride injection by local infiltration around the incision | Drug | Ropivacaine group |
| 0.9% sodium chloride injectionBefore the surgical incision was closed, an unblinded physician administered 30ml 0.9% sodium chloride injection by local infiltration around the incision | Drug | Placebo control group |
Primary outcome
Area under curve (AUC) of the pain intensity-time during 0-72h at rest
Time frame: From administration until 72 hours after administration
Area under the resting pain intensity time curve (AUC0-72h) during 0-72 hours after administration. The pain intensity was evaluated using the 11-point numerical rating scale (NRS; where 0 no pain and 10 worst possible pain).
8 secondary outcomes
Area under the pain intensity time curve at rest
Time frame: From administration until 24 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration
Area under the pain intensity time curve during exercise
Time frame: From the time of administration to 24 hours and 72 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration
Cumulative use of rescue analgesics during each period
Time frame: From the time of administration to 24 hours, 48 hours, 72 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration
The number of rescue analgesia in each period
Time frame: From the time of administration to 24 hours, 48 hours, 72 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration
Time of first morphine rescue analgesia
Time frame: From administration until 72 hours after administration
Proportion of rescue analgesia in each period
Time frame: From the time of administration to 24 hours, 48 hours, 72 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration
Trial participant satisfaction and investigator satisfaction
Time frame: From administration until 72 hours after administration
Incidence of adverse events
Time frame: From the time of administration to day 7 after administration
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 14 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RF16001 for injection, Ropivacaine hydrochloride injection and 0.9% sodium chloride injection in people with Pain After Abdominal Surgery, run by The Third Xiangya Hospital of Central South University 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 6 inclusion and 15 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: enrolling by invitation, as of the sponsor's last update on 14 Oct 2026. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve (AUC) of the pain intensity-time during 0-72h at rest (time frame: From administration until 72 hours after administration). 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 14 Oct 2026.