Anal FistulaNCT07081373
Study on Repeat Liposomal Bupivacaine for Post-Surgery Pain in Anal Fistula Patients.
A study testing A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively. in people with Anal Fistula, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Anal Fistula refers to an abnormal infectious fistula tract between the anorectum and the perianal skin. The prevalence of anal fistula is approximately 8.6 cases per 100,000 individuals. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anal Fistula
- What is being tested?
- A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2025to 30 Jun 2027
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with anal fistula and scheduled to undergo anal fistula surgery;
- Aged between 18 and 60 years;
- ASA (American Society of Anesthesiologists) physical status class I-II;
- Patient provides written informed consent after understanding the study protocol.
Who cannot join
- Anal fistula caused by specific etiologies (e.g., tuberculosis);
- Concurrent acute perianal skin infection;
- Poorly controlled diabetes (HbA1c >9%);
- Chronic use of corticosteroids;
- History of radiotherapy or chemotherapy within the past 2 weeks;
- Pregnancy or lactation;
Show all 16Show fewer
- Hypersensitivity to local anesthetics or any component of the investigational drug;
- History of substance abuse, illicit drug use, or alcohol abuse;
- Use or planned use of non-opioid/opioid analgesics within 12 hours before/during surgery;
- Concurrent treatment with anticonvulsants, MAO inhibitors, antidepressants, neuromuscular blockers, or anticholinergics within 2 weeks prior to surgery;
- Severe hepatic/renal impairment, cardiopulmonary dysfunction, coagulation disorders, or comorbidities contraindicating surgery;
- History of severe psychiatric disorders or cognitive impairment;
- Sensory disorders (e.g., hyperalgesia) or preexisting pain interfering with postoperative pain assessment;
- Contraindications to amide-type local anesthetics, opioids, or propofol;
- Participation in investigational drug trials within 90 days prior to enrollment;
- Other clinical/laboratory conditions deemed by investigators to preclude trial participation.
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
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Hongcheng Lin, MD, +86 15915815776, lhcheng@mail.sysu.edu.cn
About this study
Official title: Efficacy of Repeat Dosing of Liposomal Bupivacaine on Postoperative Pain in Patients With Anal Fistula: A Multicenter, Randomized, Open-Label, Controlled Study
Anal Fistula refers to an abnormal infectious fistula tract between the anorectum and the perianal skin. The prevalence of anal fistula is approximately 8.6 cases per 100,000 individuals. It can occur at any age but is relatively more common in individuals aged 20-40 years, with a higher incidence in males than females.
Postoperative wound management is a critical component of the overall treatment for anal fistula patients. Regular postoperative wound care, such as dressing changes, can reduce recurrence rates, alleviate pain, and shorten hospitalization time. However, postoperative pain remains a major challenge in wound management following anal fistula surgery. This is largely attributed to inadequate current postoperative analgesic protocols.
Read more
With ongoing advancements in local anesthetics, liposomal bupivacaine has been applied for postoperative analgesia. It offers higher bioavailability and a prolonged half-life, providing up to 72 hours of sustained analgesic effect. Given the limitations of existing analgesic strategies for post-anal fistula surgery, developing more effective pain management approaches to reduce postoperative pain holds significant clinical importance.
Therefore, the investigators propose that a repeat-dosing strategy based on liposomal bupivacaine may provide superior postoperative pain control for anal fistula patients. To investigate this, the investigators designed a prospective, multicenter, randomized, open-label, controlled clinical trial. This study aims to evaluate the efficacy and safety of repeat-dose liposomal bupivacaine for postoperative analgesia following anal fistula surgery, thereby generating high-level evidence to support its clinical application in this context.
- Conditions
- Anal Fistula
- Being tested
- A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively.
- Keywords
- Anal fistula, Bupivacaine liposome, Postoperative pain, Repeat dosing
- Medical subject headings
- Rectal Fistula, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively.Drug
At surgical closure, a single dose of undiluted liposomal bupivacaine (266 mg/20 mL) is administered without concurrent analgesics. The total 20 mL volume is divided into six equal aliquots (≈3.3 mL each) and infiltrated circumferentially around the incision using a 25-gauge or larger-bore needle. Injections target tissue layers above and below the fascia and within the subcutaneous plane, with frequent aspiration during administration to mitigate intravascular injection risk. Seventy-two hours postoperatively, a repeat dose of undiluted liposomal bupivacaine (266 mg/20 mL) is administered. Prior to infiltration, topical lidocaine cream is applied to the per-incisional skin for ≥20 minutes. The full 20 mL volume is then injected uniformly around the incision via circumferential needle advancement into pericicatricial tissues.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine Repeat Dosing Group | Experimental | A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively. Receives: Drug: A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively. |
| Liposomal Bupivacaine Single-Injection Group | No intervention | A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of the Numerical Rating Scale (NRS) for pain within 7 Days postoperatively (NRS-AUC0-168h)
Numerical rating scale, a numerical rating scale where participants select a number from 0 to 10 based on their subjective pain experience. On this scale:
0 represents no pain; 10 represents the most severe pain imaginable.
Measured: 7 days postoperatively
Secondary outcomes (17)
Numerical Rating Scale (NRS) for pain during wound dressing changes within 7 days postoperatively
Numerical rating scale, a numerical rating scale where participants select a number from 0 to 10 based on their subjective pain experience. On this scale: 0 represents no pain; 10 represents the most severe pain imaginable.
Measured: 7 days postoperatively
Area Under the Curve (AUC) of the Numerical Rating Scale (NRS) for pain from 96 to 168 hours postoperatively (NRS-AUC96h-168h)
Measured: 96 to 168 hours postoperatively
Number of breakthrough pain episodes and corresponding Numerical Rating Scale (NRS) scores during episodes
Numerical rating scale, a numerical rating scale where participants select a number from 0 to 10 based on their subjective pain experience. On this scale: 0 represents no pain; 10 represents the most severe pain imaginable.
Measured: 7 days postoperatively
Postoperative 7-day cumulative consumption of all analgesic drugs (calculated as morphine equivalents)
Measured: 7 days postoperatively
Postoperative 7-day cumulative consumption of rescue analgesic drugs (calculated as morphine equivalents)
Measured: 7 days postoperatively
Safety (including incidence of postoperative adverse events and serious adverse events): Adverse events and serious adverse events occurring within 14 days after medication were assessed
Measured: 14 days after medication were assessed
Postoperative heart rate monitoring: Heart rate at 24h, 48h, 72h, 96h, 120h, 144h, and 168h postoperatively.
Measured: At 24, 48, 72, 96, 120, 144, and 168 hours postoperatively.
Postoperative blood pressure monitoring: systolic blood pressure, and diastolic blood pressure at 24h, 48h, 72h, 96h, 120h, 144h, and 168h postoperatively.
Measured: At 24, 48, 72, 96, 120, 144, and 168 hours postoperatively.
SF-12 scores at preoperative, 1 week, 1 month, and 2 months postoperatively.
The 12-Item Short Form Health Survey (SF-12) is a widely used concise instrument developed by the Medical Outcomes Study (MOS) to assess an individual's health-related quality of life (HRQoL), derived as an abbreviated version of the SF-36 scale. Overall scores range from 0 to 100, with higher scores representing better health status.
Measured: 1 week, 1 month, and 2 months postoperatively.
Preoperative, 14-day postoperative, and 1-month postoperative Wexner Incontinence Scores
The Wexner Incontinence score, also termed the Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) is a fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence.
Measured: Prior to surgery; 14 days after surgery; 1 month postoperatively.
Analgesia satisfaction: Postoperative analgesic satisfaction was assessed using a 5-point categorical scale at 24h, 96h, and 168h postoperatively.
The Postoperative Analgesia Satisfaction Scale is an investigator-developed instrument where participants select a number from 0 to 4 based on their subjective experience, with higher scores representing greater satisfaction.
Measured: At 24, 96, and 168 hours postoperatively.
Wound healing rate within 8 weeks postoperatively.
Wound Healing Rate: The wound area on postoperative day 1 is defined as the initial wound area. Measure the maximum length and perpendicular width of the wound to calculate the wound area.
Formula: Wound Healing Rate = [(Initial Area - Current Area) / Initial Area] × 100%.
Measured: 8 weeks postoperatively
Wound healing time within 8 weeks postoperatively.
Wound Healing Time: The duration from initial dressing change until complete wound epithelialization is achieved.
Measured: 8 weeks postoperatively
Wound Edema Score within 8 weeks postoperatively.
Wound Edema Scoring Criteria:
3 points: Severe edema with gross elevation beyond wound margins, requiring surgical intervention; 2 points: Significant edema extending beyond wound margins, managed with dressing changes;
1 point: Mild localized edema; 0 points: No detectable edema.
Measured: 8 weeks postoperatively
Wound granulation tissue color score within 8 weeks postoperatively.
Granulation Tissue Color Scoring:
- point: Bright red;
- points: Pale red;
- points: Purple.
Measured: 8 weeks postoperatively.
Whether the wound is infected within 8 weeks postoperatively.
Measured: 8 weeks postoperatively.
Whether the wound is bleeding within 8 weeks postoperatively.
Whether bleeding is present (none, oozing, active)
Measured: 8 weeks postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start16 Jul 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Maoming People's Hospital, Dongguan Hospital of Traditional Chinese Medicine, Xingyi People's Hospital, Nanjing Hospital of C. M., People's Hospital of Xinjiang Uygur Autonomous Region
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081373
- Sponsor's protocol ID
- 2025ZSLYEC-365
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 23 Jul 2025
- 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 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Repeat Dosing of Liposomal Bupivacaine on Postoperative Pain in Patients With Anal Fistula: A Multicenter, Randomized, Open-Label, Controlled Study
- ClinicalTrials.gov ID
- NCT07081373
- Acronym / sponsor ID
- 2025ZSLYEC-365
- Conditions
- Anal Fistula
- Keywords
- Anal fistula, Bupivacaine liposome, Postoperative pain, Repeat dosing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Maoming People's Hospital, Dongguan Hospital of Traditional Chinese Medicine, Xingyi People's Hospital, Nanjing Hospital of C. M., People's Hospital of Xinjiang Uygur Autonomous Region
- Study start
- 16 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Jul 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.
Anal Fistula refers to an abnormal infectious fistula tract between the anorectum and the perianal skin. The prevalence of anal fistula is approximately 8.6 cases per 100,000 individuals. It can occur at any age but is relatively more common in individuals aged 20-40 years, with a higher incidence in males than females.
Postoperative wound management is a critical component of the overall treatment for anal fistula patients. Regular postoperative wound care, such as dressing changes, can reduce recurrence rates, alleviate pain, and shorten hospitalization time. However, postoperative pain remains a major challenge in wound management following anal fistula surgery. This is largely attributed to inadequate current postoperative analgesic protocols.
With ongoing advancements in local anesthetics, liposomal bupivacaine has been applied for postoperative analgesia. It offers higher bioavailability and a prolonged half-life, providing up to 72 hours of sustained analgesic effect. Given the limitations of existing analgesic strategies for post-anal fistula surgery, developing more effective pain management approaches to reduce postoperative pain holds significant clinical importance.
Therefore, the investigators propose that a repeat-dosing strategy based on liposomal bupivacaine may provide superior postoperative pain control for anal fistula patients. To investigate this, the investigators designed a prospective, multicenter, randomized, open-label, controlled clinical trial. This study aims to evaluate the efficacy and safety of repeat-dose liposomal bupivacaine for postoperative analgesia following anal fistula surgery, thereby generating high-level evidence to support its clinical application in this context.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine Repeat Dosing Group | Experimental | Drug: A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively.A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively. |
| Liposomal Bupivacaine Single-Injection Group | No intervention | –A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed with anal fistula and scheduled to undergo anal fistula surgery;
- Aged between 18 and 60 years;
- ASA (American Society of Anesthesiologists) physical status class I-II;
- Patient provides written informed consent after understanding the study protocol.
Key exclusion criteria (16 listed)
- Anal fistula caused by specific etiologies (e.g., tuberculosis);
- Concurrent acute perianal skin infection;
- Poorly controlled diabetes (HbA1c >9%);
- Chronic use of corticosteroids;
- History of radiotherapy or chemotherapy within the past 2 weeks;
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 |
|---|---|---|
| A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively.At surgical closure, a single dose of undiluted liposomal bupivacaine (266 mg/20 mL) is administered without concurrent analgesics. The total 20 mL volume is divided into six equal aliquots (≈3.3 mL each) and infiltrated circumferentially around the incision using a 25-gauge or larger-bore needle. Injections target tissue layers above and below the fascia and within the subcutaneous plane, with frequent aspiration during administration to mitigate intravascular injection risk. Seventy-two hours postoperatively, a repeat dose of undiluted liposomal bupivacaine (266 mg/20 mL) is administered. Prior to infiltration, topical lidocaine cream is applied to the per-incisional skin for ≥20 minutes. The full 20 mL volume is then injected uniformly around the incision via circumferential needle advancement into pericicatricial tissues. | Drug | Liposomal Bupivacaine Repeat Dosing Group |
Primary outcome
Area Under the Curve (AUC) of the Numerical Rating Scale (NRS) for pain within 7 Days postoperatively (NRS-AUC0-168h)
Time frame: 7 days postoperatively
Numerical rating scale, a numerical rating scale where participants select a number from 0 to 10 based on their subjective pain experience. On this scale: 0 represents no pain; 10 represents the most severe pain imaginable.
17 secondary outcomes
Numerical Rating Scale (NRS) for pain during wound dressing changes within 7 days postoperatively
Time frame: 7 days postoperatively
Area Under the Curve (AUC) of the Numerical Rating Scale (NRS) for pain from 96 to 168 hours postoperatively (NRS-AUC96h-168h)
Time frame: 96 to 168 hours postoperatively
Number of breakthrough pain episodes and corresponding Numerical Rating Scale (NRS) scores during episodes
Time frame: 7 days postoperatively
Postoperative 7-day cumulative consumption of all analgesic drugs (calculated as morphine equivalents)
Time frame: 7 days postoperatively
Postoperative 7-day cumulative consumption of rescue analgesic drugs (calculated as morphine equivalents)
Time frame: 7 days postoperatively
Safety (including incidence of postoperative adverse events and serious adverse events): Adverse events and serious adverse events occurring within 14 days after medication were assessed
Time frame: 14 days after medication were assessed
Postoperative heart rate monitoring: Heart rate at 24h, 48h, 72h, 96h, 120h, 144h, and 168h postoperatively.
Time frame: At 24, 48, 72, 96, 120, 144, and 168 hours postoperatively.
Postoperative blood pressure monitoring: systolic blood pressure, and diastolic blood pressure at 24h, 48h, 72h, 96h, 120h, 144h, and 168h postoperatively.
Time frame: At 24, 48, 72, 96, 120, 144, and 168 hours postoperatively.
SF-12 scores at preoperative, 1 week, 1 month, and 2 months postoperatively.
Time frame: 1 week, 1 month, and 2 months postoperatively.
Preoperative, 14-day postoperative, and 1-month postoperative Wexner Incontinence Scores
Time frame: Prior to surgery; 14 days after surgery; 1 month postoperatively.
Analgesia satisfaction: Postoperative analgesic satisfaction was assessed using a 5-point categorical scale at 24h, 96h, and 168h postoperatively.
Time frame: At 24, 96, and 168 hours postoperatively.
Wound healing rate within 8 weeks postoperatively.
Time frame: 8 weeks postoperatively
Wound healing time within 8 weeks postoperatively.
Time frame: 8 weeks postoperatively
Wound Edema Score within 8 weeks postoperatively.
Time frame: 8 weeks postoperatively
Wound granulation tissue color score within 8 weeks postoperatively.
Time frame: 8 weeks postoperatively.
Whether the wound is infected within 8 weeks postoperatively.
Time frame: 8 weeks postoperatively.
Whether the wound is bleeding within 8 weeks postoperatively.
Time frame: 8 weeks postoperatively.
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 23 Jul 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively. in people with Anal Fistula, run by Sixth Affiliated Hospital, Sun Yat-sen 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 4 inclusion and 16 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 23 Jul 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.
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 Hongcheng Lin, MD (+86 15915815776, lhcheng@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) of the Numerical Rating Scale (NRS) for pain within 7 Days postoperatively (NRS-AUC0-168h) (time frame: 7 days 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 23 Jul 2025.