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Comparison of the efficacy of oral non-steroidal anti-inflammatory drugs versus opioid painkillers after external dissection and internal ligation of mixed hemorrhoids: An open-label randomized controlled study

Comparison of the efficacy of oral non-steroidal anti-inflammatory drugs versus opioid painkillers after external dissection and internal ligation of mixed hemorrhoids: An open-label randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127488
Enrollment
Unknown
Registered
2026-07-01
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Postoperative pain after hemorrhoidectomy

Interventions

Loratropine Sodium Group:Patients in the losofen sodium group received oral administration of losofen sodium tablets (60 mg every 8 hours as needed) for pain relief.
Amphetamine hydrocodone group:Patients in the amfeprofen oxycodone group received oral administration of amfeprofen oxycodone tablets (5mg / 6 hours as needed) for pain relief.

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old; 2. Patients diagnosed with severe circular mixed hemorrhoids according to the Chinese Guidelines for the Diagnosis and Treatment of Hemorrhoids (2020) and who underwent external dissection and internal ligation of mixed hemorrhoids during hospitalization; 3. Voluntarily sign the informed consent form and follow the requirements of the protocol;

Exclusion criteria

Exclusion criteria: 1.Patients with acute inflammatory reactions in the anal area (anal infection, abscess); 2. Patients with contraindications to non-steroidal anti-inflammatory drugs (such as gastric ulcers, asthma) and opioid contraindications (respiratory depression); 3. Patients who are allergic to non-steroidal anti-inflammatory drugs or paracetamol and oxycodone tablets; 4. Chronic inflammatory bowel disease (such as Crohn's disease); 5. There are severe diseases of vital organs or autoimmune insufficiency; 6. Pregnant women, lactating women or those who cannot use contraception during the study period; 7. Those with a history of severe systemic diseases or mental illness/neurological dysfunction; 8. Other circumstances where the researcher deems it inappropriate to participate in the study;

Design outcomes

Primary

MeasureTime frame
The average VAS pain score of the subjects within 4 weeks after the operation;The average VAS pain score of the subjects within two weeks after the operation;

Secondary

MeasureTime frame
Actual dosage and frequency of the medication;The average VAS pain score 1 week after the operation;The HDSS score at the 4th week after the operation;The average VAS pain score 24 hours after the operation;The score of the European Five-Dimensional Health Quality of Life Scale (EQ-5D-3L) at the 4th week after the operation;Satisfaction level;The HDSS score at the 2nd week after the operation;The score of the European Five-Dimensional Health Quality of Life Scale (EQ-5D-3L) at the 12th week after the operation;The average VAS pain score 8 hours after the operation;The average VAS pain score 36 hours after the operation;The score of the European Five-Dimensional Health Quality of Life Scale (EQ-5D-3L) at the 2nd week after the operation;The HDSS score at the 12th week after the operation;Recurrent rate;

Countries

China

Contacts

Public ContactMa Huangfu

China-Japan Friendship Hospital

362715561@qq.com+86 10 53236552

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026