Topical Analgesia Post-Haemorrhoidectomy

NCT04276298 | Completed Phase 2 DMC

• 1 other identifier: RCT Haemorrhoidectomy
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

Symptomatic haemorrhoids, or piles, have significant effects on quality of life. The treatment for advanced disease is surgical excision (haemorrhoidectomy) which is extremely effective. However, pain following haemorrhoidectomy is known by all to be a miserable experience and current treatment is not very effective. We have formulated a new cream treatment which targets three theorised mechanisms of pain after haemorrhoidectomy. We will test the effectiveness of the treatments with a multi-centred randomised controlled factorial trial with four parallel double-blinded arms containing different combinations of the active agents. The outcomes include pain scores, amount of analgesia required and time to return to work. The results of our study could provide evidence of an effective treatment for post haemorrhoidectomy pain. The treatment may provide considerable benefit to patients undergoing this surgical procedure.

Conditions

Hemorrhoid Pain; Hemorrhoids

Outcome Measures

Primary Outcomes (2)

• Pain scores

  Measured by visual analog scale, 1-10cm, continuous, the higher the score, the worse the pain

  7 days

• Amount of analgesic use

  Morphine equivalent amount

  7 days

Secondary Outcomes (5)

• Return to work

  14 days

• Pain on bowel motion: Visual Analog Scale

  7 days

• Complications

  30 days

• Re-admission

  30 days

• Repeat Prescription

  30 days

Study Arms (4)

Metronidazole

ACTIVE COMPARATOR

Group A receiving 10% metronidazole cream

Drug: Metronidazole cream

Metronidazole + Diltiazem

ACTIVE COMPARATOR

Metronidazole 10% + Diltiazem 2%

Drug: Metronidazole and Diltiazem cream

Metronidazole + Lignocaine

ACTIVE COMPARATOR

Metronidazole 10% + Lignocaine 4%

Drug: Metronidazole and Lidocaine cream

Metronidazole + Diltiazem + Lignocaine

ACTIVE COMPARATOR

Metronidazole 10% + Diltiazem 2% + Lignocaine 4%

Drug: Metronidazole, Diltiazem and Lidocaine cream

Interventions

Metronidazole cream DRUG

10% metronidazole applied rectally

Metronidazole

Metronidazole and Diltiazem cream DRUG

Combination Metronidazole and Diltiazem applied rectally

Metronidazole + Diltiazem

Metronidazole and Lidocaine cream DRUG

Combination metronidazole and lignocaine applied rectally

Metronidazole + Lignocaine

Metronidazole, Diltiazem and Lidocaine cream DRUG

Combination of all active agents tested applied rectally

Metronidazole + Diltiazem + Lignocaine

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥16
• All patients undergoing excisional haemorrhoidectomy

You may not qualify if:

• Age \<16,
• history of chronic pain,
• drug allergy or idiosyncracies to any actives or excipients in
• cream,
• breastfeeding,
• any medical history which is a contraindication to any of metronidazole, lidocaine, or diltiazem including including:
• sick sinus syndrome,
• atrioventricular block,
• hypotension,
• heart failure and bradycardia.
• concomitant medications which are contraindicated to metronidazole, lidocaine or diltiazem.
• patients already taking diltiazem.

Sponsors & Collaborators

• University of Auckland, New Zealand: lead

Study Sites (1)

Counties Manukau District Health Board

Auckland, 1041, New Zealand

Location

Related Publications (1)

• Jin JZ, Xia W, Gao R, Vandal AC, Weston M, Israel L, Connolly A, Singh PP, Svirskis D, Hill A. A Randomized Controlled Trial of Topical Analgesia Posthemorrhoidectomy (TAPH Trial). Dis Colon Rectum. 2024 Sep 1;67(9):1158-1168. doi: 10.1097/DCR.0000000000003419. Epub 2024 Jun 11.

  PMID: 38871679 DERIVED

MeSH Terms

Conditions

Hemorrhoids

Interventions

Metronidazole; Diltiazem

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Andrew G Hill, MBChB, MD, EdD, FRACS, FACS

  Counties Manukau Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double blinded trial, both participant and investigator are blinded.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Head of School

Model Details: Parallel with 1:1:1:1 Allocation.

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: September 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: When results are available for 12 months
• Access Criteria: email request

Locations

NZ (1)