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The Feasibility of lidocaine based paste versus combined with either sucralfate, metronidazole as an adjunctive treatment for pain control after hemorrhoidectomy in Grade 3 and 4 hemorrhoids patients, A randomized controlled trial, double-blinded, pilot study

The Feasibility of lidocaine based paste versus combined with either sucralfate, metronidazole as an adjunctive treatment for pain control after hemorrhoidectomy in Grade 3 and 4 hemorrhoids patients, A randomized controlled trial, double-blinded, pilot study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260601017
Enrollment
90
Registered
2026-06-01
Start date
2026-05-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

1. Hemorrhoid grades 3 and 4 2. Undergo Hemorrhoidectomy 3. Age 20 - 60 years 4. At Maharaj Nakorn Chiang Mai Hospital Hemorrhoid, Hemorrhoidectomy, lidocaine based, sucralfate, metronidazole , adjunctive treatment

Interventions

Topical 2% Xylocaine jelly applied three times daily (morning, evening, and before bedtime).,A combination of Metronidazole (1%) and Lidocaine, prepared by mixing 0.1 g of Metronidazole tablet with 10
Active Comparator Drug,Active Comparator Drug,Active Comparator Drug
Lidocaine Group,Lidocaine + Metronidazole Group,Lidocaine + Sucralfate Group

Sponsors

None
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Hemorrhoid grades 3 and 4 2. Undergo Hemorrhoidectomy 3. Age 20 - 60 years 4. Provided informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patients who have a history of Inflammatory bowel disease, anal fissure, anal fistula, colorectal malignancy, history of radiation 2. Patients over the age of 50 who have not undergone a colonoscopy before hemorrhoidectomy to rule out colorectal cancer 3. Patients who have a history of hypersensitivity to metronidazole, lidocaine nor sucralfate 4. Any psychotic disorder, language barrier 5. Any cognitive impairment or Inability to communicate 6. Refuse to participate 7. Pregnancy and breastfeeding 8. Patient with emergency condition related to hemorrhoid such as thrombosed or strangulated

Design outcomes

Primary

MeasureTime frame
Pain score (as Visual analog score), QoR 15, post-operative fecal incontinence (The Wexner score) at 24, 48hrs, Day 4 and Day 7 post-operatively Pain score (as Visual analog score)

Secondary

MeasureTime frame
Intravenous opioids use for pain control day 1 and day 2 Mg

Countries

Thailand

Contacts

Public ContactSawita Kuanprasert

Faculty of Medicine, Chiang Mai University

sawita.kps@gmail.com0991469264

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026