A comparison of 2 different medicated ointments with placebo for pain relief after banding of haemorrhoids

Category Primary study
Registry of TrialsANZCTR
Year 2020
INTERVENTION: The interventions consist of 3 different ointments: ‐lignocaine 2% in polyethylene glycol (PEG) base or ‐lignocaine 2% and diltiazem 2% in polyethylene glycol (PEG) base A 2cm length of ointment will be digitally applied to the anal area 3 times per day for 5 days from the procedure. Each participant will record in a written diary that the ointment has been applied. CONDITION: haemorrhoids; ; haemorrhoids Oral and Gastrointestinal ‐ Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon PRIMARY OUTCOME: Pain scores between the 3 arms will be assessed using a standardised 10‐point patient reported continuous visual analogue scale (zero represented no pain at all, and ten represented the severest pain imaginable)[• 30 minutes; • 1 hour; • 6 hours; • 12 hours; • 24 hours; • 48 hours] SECONDARY OUTCOME: Incidence of repeat procedure[Within 30 days of index procedure will be compared between groups based on medical record review.] Patient reported satisfaction with analgesia after discharge (Likert scale and percent satisfaction)[At day 5.] Patients not requiring opiates[ Recorded at days 1,2 and 3 and 4 post‐procedure by a self‐completed diary.] Post‐operative surgical complications graded by the Clavien‐Dindo Classification of Surgical Complications up to day 30 post‐procedure as reported by the participant at day 30 follow‐up and/or from the medical record if admitted for any reason poast‐procedure[Up to day 30 post‐procedure as reported by the participant at day 30 follow‐up and/or from the medical record if admitted for any reason post‐procedure] Proportion of participants that would recommend the procedure to friends or family if they required it [Assessed at day 30 post‐procedure at phone follow‐up.] Proportion of patients developing urinary retention requiring catheterization between groups as recorded in medical record or reported by the patient.[By day 30 post‐procedure] Time off work in days [Up to day 30 post‐procedure as reported by the participant at 30 day phone follow‐up.] Total opioid analgesic usage as reported by the patient in oral morphine milli‐equivalents.[Day of procedure and days 1,2 and 3 post‐procedure] INCLUSION CRITERIA: Patients aged 18 years and over who present to the colorectal outpatient clinic or the private rooms of participating surgeons with symptomatic haemorrhoids suitable for banding will be considered for inclusion and offered study information.
Epistemonikos ID: cb3bf01f7af85a9d5378c656acef224c54838b96
First added on: Aug 24, 2024