Mixed HemorrhoidsPhase 4NCT07164807
Efficacy of Methylene Blue Plus Ropivacaine for Post-Hemorrhoidectomy Pain.
A Phase 4 study testing Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%) and Methylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%) in people with Mixed Hemorrhoids and Milligan-Morgan Hemorrhoidectomy, run by The Affiliated Hospital of Putian University at 1 site in China.
Trial summary
Revised Translation (Academic English): As one of the most prevalent anorectal disorders, mixed hemorrhoids continue to rely on the Milligan-Morgan hemorrhoidectomy as the gold-standard surgical approach. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mixed Hemorrhoids, Milligan-Morgan Hemorrhoidectomy, Methylene Blue
- What is being tested?
- Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%) and Methylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2025to Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 years.
- Diagnosed with Grade III-IV hemorrhoids according to the Goligher classification.
- Scheduled to undergo standard Milligan-Morgan hemorrhoidectomy.
- Procedure performed under spinal anesthesia alone.
Who cannot join
- Pregnancy or lactation.
- Current immunotherapy or coagulopathies.
- Contraindications to any protocol-specified agents (e.g., history of severe allergic reactions to methylene blue or ropivacaine).
- Concurrent anorectal pathologies (e.g., perianal abscess, anal fistula, fecal incontinence).
- Comorbid systemic conditions (e.g., cardiac/hepatic/renal insufficiency, diabetes mellitus, coagulopathy, peptic ulcer disease).
- Incomplete perioperative documentation.
- Inability to comply with follow-up protocols.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Efficacy of Varying Concentrations of Methylene Blue Combined With Ropivacaine for Postoperative Analgesia Following Milligan-Morgan Hemorrhoidectomy: A Single-Center, Prospective, Open-Label, Randomized, Parallel-Controlled Trial
Revised Translation (Academic English):
As one of the most prevalent anorectal disorders, mixed hemorrhoids continue to rely on the Milligan-Morgan hemorrhoidectomy as the gold-standard surgical approach. While this technique demonstrates well-established efficacy, managing acute postoperative pain-particularly during the critical 24-72-hour peak pain window-remains a persistent clinical challenge. Recent advancements in multimodal analgesia have highlighted the potential of local nerve blockers, with methylene blue (MB) gaining scientific interest due to its prolonged analgesic properties. This randomized controlled study systematically evaluates the synergistic analgesic effects of gradient concentrations of MB combined with ropivacaine (ROP) following Milligan-Morgan procedures. Therapeutic safety profiles were validated through dual-dimensional monitoring of Visual Analog Scale (VAS) scores and complication rates, aiming to establish evidence-based optimal dosing protocols and refine perioperative pain management strategies.
- Being tested
- Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%), Methylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%)Drug
Perianal subcutaneous injection of 0.3% methylene blue solution (Formulation: 1.5 mL of 1% methylene blue with 3.5 mL ropivacaine hydrochloride injection).
Methylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%)Drug
Perianal subcutaneous injection of 0.1% methylene blue solution (Formulation: 0.5 mL of 1% methylene blue with 4.5 mL ropivacaine hydrochloride injection).
| Study group | Role | What they receive |
|---|---|---|
| High-Concentration Methylene Blue with Ropivacaine Group | Experimental | Intervention: Perianal subcutaneous injection of 0.1% methylene blue solution (Formulation: 0.5 mL of 1% methylene blue with 4.5 mL ropivacaine hydrochloride injection). Receives: Drug: Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%) |
| Low-Concentration Methylene Blue with Ropivacaine | Experimental | Intervention: Perianal subcutaneous injection of 0.3% methylene blue solution (Formulation: 1.5 mL of 1% methylene blue with 3.5 mL ropivacaine hydrochloride injection). Receives: Drug: Methylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%) |
| Ropivacaine hydrochloride injection Group | No intervention | Postoperative protocol: No routine preemptive analgesia administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Numerical Rating Scale (NRS) Pain Scores
Assessment timepoints: At postoperative days 1, 2, 3, 4, 5days, 2 weeks, and 1 month.0 usually means "no pain."10 means "the worst pain imaginable.
Measured: Within 30 days after surgery
Total Postoperative Analgesic Consumption
Metric: Cumulative dosage of rescue analgesics (e.g., NSAIDs or opioids) administered during the follow-up period.
Measured: Within 30 days after surgery
Postoperative Quality of Life (QoL) Metrics
Postoperative QoL metrics are standardized tools (questionnaires, surveys) used to measure a patient's overall well-being and functional status after a surgical procedure.patients rate their overall health from 0 (worst) to 100 (best).
Measured: Within 30 days after surgery
Secondary outcomes (1)
Incidence of Postoperative Complications
Documented adverse events:urinary retention,secondary hemorrhage,perianal edema,secondary infection,pruritus and other procedure-related morbidities.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start30 Aug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed HemorrhoidsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Putian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164807
- Sponsor's protocol ID
- AHPuTianU-011
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2025
- Last updated
- 10 Sep 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Varying Concentrations of Methylene Blue Combined With Ropivacaine for Postoperative Analgesia Following Milligan-Morgan Hemorrhoidectomy: A Single-Center, Prospective, Open-Label, Randomized, Parallel-Controlled Trial
- ClinicalTrials.gov ID
- NCT07164807
- Acronym / sponsor ID
- AHPuTianU-011
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Putian UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Sep 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.
Revised Translation (Academic English):
As one of the most prevalent anorectal disorders, mixed hemorrhoids continue to rely on the Milligan-Morgan hemorrhoidectomy as the gold-standard surgical approach. While this technique demonstrates well-established efficacy, managing acute postoperative pain-particularly during the critical 24-72-hour peak pain window-remains a persistent clinical challenge. Recent advancements in multimodal analgesia have highlighted the potential of local nerve blockers, with methylene blue (MB) gaining scientific interest due to its prolonged analgesic properties. This randomized controlled study systematically evaluates the synergistic analgesic effects of gradient concentrations of MB combined with ropivacaine (ROP) following Milligan-Morgan procedures. Therapeutic safety profiles were validated through dual-dimensional monitoring of Visual Analog Scale (VAS) scores and complication rates, aiming to establish evidence-based optimal dosing protocols and refine perioperative pain management strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Concentration Methylene Blue with Ropivacaine Group | Experimental | Drug: Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%)Intervention: Perianal subcutaneous injection of 0.1% methylene blue solution (Formulation: 0.5 mL of 1% methylene blue with 4.5 mL ropivacaine hydrochloride injection). |
| Low-Concentration Methylene Blue with Ropivacaine | Experimental | Drug: Methylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%)Intervention: Perianal subcutaneous injection of 0.3% methylene blue solution (Formulation: 1.5 mL of 1% methylene blue with 3.5 mL ropivacaine hydrochloride injection). |
| Ropivacaine hydrochloride injection Group | No intervention | –Postoperative protocol: No routine preemptive analgesia administered. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 75 years.
- Diagnosed with Grade III-IV hemorrhoids according to the Goligher classification.
- Scheduled to undergo standard Milligan-Morgan hemorrhoidectomy.
- Procedure performed under spinal anesthesia alone.
Key exclusion criteria (7 listed)
- Pregnancy or lactation.
- Current immunotherapy or coagulopathies.
- Contraindications to any protocol-specified agents (e.g., history of severe allergic reactions to methylene blue or ropivacaine).
- Concurrent anorectal pathologies (e.g., perianal abscess, anal fistula, fecal incontinence).
- Comorbid systemic conditions (e.g., cardiac/hepatic/renal insufficiency, diabetes mellitus, coagulopathy, peptic ulcer disease).
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 |
|---|---|---|
| Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%)Perianal subcutaneous injection of 0.3% methylene blue solution (Formulation: 1.5 mL of 1% methylene blue with 3.5 mL ropivacaine hydrochloride injection). | Drug | High-Concentration Methylene Blue with Ropivacaine Group |
| Methylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%)Perianal subcutaneous injection of 0.1% methylene blue solution (Formulation: 0.5 mL of 1% methylene blue with 4.5 mL ropivacaine hydrochloride injection). | Drug | Low-Concentration Methylene Blue with Ropivacaine |
Primary outcome
Postoperative Numerical Rating Scale (NRS) Pain Scores
Time frame: Within 30 days after surgery
Assessment timepoints: At postoperative days 1, 2, 3, 4, 5days, 2 weeks, and 1 month.0 usually means "no pain."10 means "the worst pain imaginable.
Total Postoperative Analgesic Consumption
Time frame: Within 30 days after surgery
Metric: Cumulative dosage of rescue analgesics (e.g., NSAIDs or opioids) administered during the follow-up period.
Postoperative Quality of Life (QoL) Metrics
Time frame: Within 30 days after surgery
Postoperative QoL metrics are standardized tools (questionnaires, surveys) used to measure a patient's overall well-being and functional status after a surgical procedure.patients rate their overall health from 0 (worst) to 100 (best).
1 secondary outcome
Incidence of Postoperative Complications
Time frame: Within 30 days after 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 10 Sep 2025.
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Application of Dynamic Pain Assessment and Management System in Perioperative Period of Patients With Incarcerated Mixed Hemorrhoids
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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 Phase 4 study testing Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%) and Methylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%) in people with Mixed Hemorrhoids and Milligan-Morgan Hemorrhoidectomy, run by The Affiliated Hospital of Putian 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 7 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: opening soon, as of the sponsor's last update on 10 Sep 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 Chenxing Jian, MD.,PHD. (+86-13959538950, ptyyjcx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Numerical Rating Scale (NRS) Pain Scores (time frame: Within 30 days after surgery). The study lists 3 primary outcomes in all. 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 10 Sep 2025.