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Recruiting NCT06420388

NCT06420388 2% Lidocaine Gel in Reducing Postoperative Pain Following Haemorrhoidectomy

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Clinical Trial Summary
NCT ID NCT06420388
Status Recruiting
Phase
Sponsor E-DA Hospital
Condition Surgery
Study Type INTERVENTIONAL
Enrollment 400 participants
Start Date 2023-05-01
Primary Completion 2024-07-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 80 Years
Study Type INTERVENTIONAL
Interventions
2% Lidocaine GelWater-based Lubricant Gel (K-Y Gel)Standard Postoperative Analgesics

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 400 participants in total. It began in 2023-05-01 with a primary completion date of 2024-07-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The study is a randomized, double-blind, controlled trial evaluating the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption after haemorrhoidectomy. 222 patients undergoing Ferguson haemorrhoidectomy will be randomly assigned to receive either 2% lidocaine gel or a non-anaesthetic lubricant gel control. Pain scores using a visual analog scale (VAS) will be assessed at 12 and 24 hours, and 2, 3, and 7 days postoperatively. Analgesic consumption will also be measured.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or older * Diagnosed with Grade III or IV hemorrhoids * Candidate for Ferguson haemorrhoidectomy Exclusion Criteria: * Not a candidate for Ferguson haemorrhoidectomy * Recurrent hemorrhoidal disease * Concurrent anal pathology diagnosed preoperatively, including: * Anal fistula * Anal fissure * Anal polyp * History of diabetes mellitus * History of liver cirrhosis * History of inflammatory bowel disease * Documented neuropathy * Coagulation disorders * Currently on anticoagulants * Documented allergy to any of the drugs included in the protocol

Contact & Investigator

Central Contact

Chen Chih-i

✉ ed111988@edah.org.tw

📞 +886978060015

Principal Investigator

Chen Chih-I

STUDY DIRECTOR

E-DA Hospital

Frequently Asked Questions

Who can join the NCT06420388 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06420388 currently recruiting?

Yes, NCT06420388 is actively recruiting participants. Contact the research team at ed111988@edah.org.tw for enrollment information.

Where is the NCT06420388 trial being conducted?

This trial is being conducted at Kaohsiung City, Taiwan.

Who is sponsoring the NCT06420388 clinical trial?

NCT06420388 is sponsored by E-DA Hospital. The principal investigator is Chen Chih-I at E-DA Hospital. The trial plans to enroll 400 participants.

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