PLATIPUS Trial: comparison of different pain relief strategies in haemorrhoid banding

Not Applicable

Recruiting

• Conditions: Haemorrhoids; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622000006741
• Lead Sponsor: Mr David Proud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-11
• Last Update Posted: 23 January 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

The inclusion criteria for this study are:
-Adults aged 18 years or older, AND
-Consented for rubber band ligation of haemorrhoid disease

Exclusion Criteria

Exclusion criteria are: (1) previous reaction to the LA agents used in this study (i.e. ropivacaine, bupivacaine); (2) additional anorectal conditions (e.g. Crohn’s disease, anal fissure); or (3) receiving RBL in conjunction with another major interventional procedure. Patients will remain eligible if they undergo minor interventional procedures (e.g. polypectomy) or non-interventional procedures (e.g. colonoscopy).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study is patient-reported post-procedural pain scores. Pain scores will be assessed using the Numerical Rating Scale (NRS), which asks patients to rate their current level of pain as an integer on a scale of 0 – 10, with 0 being no pain” and 10 being worst possible pain”. This scale is used extensively in clinical and research settings and has been validated as a sensitive and reliable measure of pain. [The primary outcome measure of this study is patient-reported pain scores at thirty minutes, two hours, four hours, 24 hours and two weeks post-procedure. The pre-specified time point of primary interest is thirty minutes. ]