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Randomized controlled study on the analgesic effect of bupivacaine liposomes, a long-acting local anesthetic, compared to ropivacaine in local anesthesia after hemorrhoidectomy and its potential to reduce opioid demand

Randomized controlled study on the analgesic effect of bupivacaine liposomes, a long-acting local anesthetic, compared to ropivacaine in local anesthesia after hemorrhoidectomy and its potential to reduce opioid demand

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127169
Enrollment
Unknown
Registered
2026-06-25
Start date
2026-06-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemorrhoids

Interventions

Bupivacaine liposome group:Within 10 minutes after the surgery, the non-blinded researcher injected the test drug by infiltration at four different locations around the subject's anus. The test group
Ropivacaine group:Within 10 minutes after the surgery, the non-blinded researcher injected the test drug into four different locations around the subject's anus. The control group received an injectio

Sponsors

General Hospital of the Northern Theater Command of the Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-40 years, with no gender preference; 2. Planned for elective hemorrhoidectomy under spinal anesthesia, with ASA classification of I-II; 3. No history of allergy to bupivacaine, ropivacaine, or excipients; 4. Willing to voluntarily sign the informed consent form and cooperate with research follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. History of chronic pain or long-term opioid dependence; 3. Patients with severe abnormalities in liver and kidney functions and coagulation disorders; 4. Patients with perianal infection, perianal abscess or inflammatory bowel disease; 5. Those who have participated in other clinical trials within the past 30 days; 6. Non-steroidal anti-inflammatory drugs, opioid analgesics or other drugs that affect the pain score have been used within 3 days before the operation; 7. Those with severe cardiovascular diseases, neuromuscular diseases or contraindications to the use of local anesthetics; 8. Allergic to or contraindicated to remedial analgesic drugs; 9. Other circumstances where the researcher deems it unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
VAS scores at 24, 48, and 72 hours after surgery;

Secondary

MeasureTime frame
Remedial analgesic drug dosage;Time of first rescue analgesic medication;First time out of bed(h);First exhaust time(h);Length of hospital stay (days);QoR-40 scale score;Patient satisfaction score (Likert 5-point scale);Local reaction (redness/swelling/itching/infection);Systemic reactions (nausea/vomiting/urinary retention);Bromage score;The wound healed 3 days after surgery;Chronic pain 30 days after surgery;

Countries

China

Contacts

Public ContactQi Yue

General Hospital of the Northern Theater Command of the Chinese People's Liberation Army

qiyue9898@qq.com+86 158 4015 6482

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026