Hemorrhoid PainPhase 2/3NCT04276298
Topical Analgesia Post-Haemorrhoidectomy
A Phase 2/3 study testing Metronidazole cream, Metronidazole and Diltiazem cream and Metronidazole and Lidocaine cream in people with Hemorrhoid Pain and Hemorrhoids, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoid Pain, Hemorrhoids
- What is being tested?
- Metronidazole cream, Metronidazole and Diltiazem cream and Metronidazole and Lidocaine cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteNew Zealand
- Study dates
- 1 Sep 2020to 1 Feb 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age ≥16
- All patients undergoing excisional haemorrhoidectomy
Who cannot join
- 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:
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- sick sinus syndrome,
- atrioventricular block,
- hypotension,
- heart failure and bradycardia.
- concomitant medications which are contraindicated to metronidazole, lidocaine or diltiazem.
- patients already taking diltiazem.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicentre, Double-Blinded Randomised Controlled Trial Comparing Topical Metronidazole, Diltiazem and Lidocaine on Post-Operative Pain Following Excisional Haemorrhoidectomy
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.
Read the detailed description
Study Design: This will be a patient-and-investigator blinded factorial randomised trial with four parallel groups. Participants in all four groups will be instructed to apply cream 3 times a day for 7 days after surgery. A standard analgesia prescription will be provided with laxatives as per routine care. Patients will be provided a questionnaire to complete and return on day 14.
Random Sequence Generation: Computer generated sequence allocating patients to a 1:1:1:1 ratio using permuted block randomisation in blocks of 12.
Allocation Concealment: This randomisation code will be seeded to the pharmacist to who will package and label the cream according to a code. The creams will be indistinguishable to which active ingredient they contain.
Assignment of intervention: Patients will be assigned in order according to the numbering of the cream tubes by the blinded investigator.
Data recording: Data will be recorded on Redcap database.
- Conditions
- Hemorrhoid Pain, Hemorrhoids
- Being tested
- Metronidazole cream, Metronidazole and Diltiazem cream, Metronidazole and Lidocaine cream, Metronidazole, Diltiazem and Lidocaine cream
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole creamDrug
10% metronidazole applied rectally
Metronidazole and Diltiazem creamDrug
Combination Metronidazole and Diltiazem applied rectally
Metronidazole and Lidocaine creamDrug
Combination metronidazole and lignocaine applied rectally
Metronidazole, Diltiazem and Lidocaine creamDrug
Combination of all active agents tested applied rectally
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole | Active comparator | Group A receiving 10% metronidazole cream Receives: Drug: Metronidazole cream |
| Metronidazole + Diltiazem | Active comparator | Metronidazole 10% + Diltiazem 2% Receives: Drug: Metronidazole and Diltiazem cream |
| Metronidazole + Lignocaine | Active comparator | Metronidazole 10% + Lignocaine 4% Receives: Drug: Metronidazole and Lidocaine cream |
| Metronidazole + Diltiazem + Lignocaine | Active comparator | Metronidazole 10% + Diltiazem 2% + Lignocaine 4% Receives: Drug: Metronidazole, Diltiazem and Lidocaine cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Measured by visual analog scale, 1-10cm, continuous, the higher the score, the worse the pain
Measured: 7 days
Amount of analgesic use
Morphine equivalent amount
Measured: 7 days
Secondary outcomes (5)
Return to work
Day post-operation when the patient returns to work
Measured: 14 days
Pain on bowel motion: Visual Analog Scale
Measured by Visual Analog Scale, continuous 1-10cm, the higher the score, the worse the pain.
Measured: 7 days
Complications
Rates of Bleeding
Measured: 30 days
Re-admission
Rates of Re-admission to hospital,
Measured: 30 days
Repeat Prescription
Rates of Repeat Prescription Requirement
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Sep 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhoid PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Parallel with 1:1:1:1 Allocation.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew G Hill, MBChB, MD (Thesis), EdD, FACS, FRACS, University of Auckland, New Zealand
- Investigators
- Andrew G Hill, MBChB, MD, EdD, FRACS, FACS, Principal investigator, Counties Manukau Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276298
- Sponsor's protocol ID
- RCT Haemorrhoidectomy
- Status last verified
- May 2022
- First submitted
- 17 Feb 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be shared when results become available.
Publications
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.
PubMed 38871679
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Double-Blinded Randomised Controlled Trial Comparing Topical Metronidazole, Diltiazem and Lidocaine on Post-Operative Pain Following Excisional Haemorrhoidectomy
- ClinicalTrials.gov ID
- NCT04276298
- Acronym / sponsor ID
- RCT Haemorrhoidectomy
- Conditions
- Hemorrhoid Pain, Hemorrhoids
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design: This will be a patient-and-investigator blinded factorial randomised trial with four parallel groups. Participants in all four groups will be instructed to apply cream 3 times a day for 7 days after surgery. A standard analgesia prescription will be provided with laxatives as per routine care. Patients will be provided a questionnaire to complete and return on day 14.
Random Sequence Generation: Computer generated sequence allocating patients to a 1:1:1:1 ratio using permuted block randomisation in blocks of 12.
Allocation Concealment: This randomisation code will be seeded to the pharmacist to who will package and label the cream according to a code. The creams will be indistinguishable to which active ingredient they contain.
Assignment of intervention: Patients will be assigned in order according to the numbering of the cream tubes by the blinded investigator.
Data recording: Data will be recorded on Redcap database.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Parallel with 1:1:1:1 Allocation.
| Arm | Type | Receives |
|---|---|---|
| Metronidazole | Active comparator | Drug: Metronidazole creamGroup A receiving 10% metronidazole cream |
| Metronidazole + Diltiazem | Active comparator | Drug: Metronidazole and Diltiazem creamMetronidazole 10% + Diltiazem 2% |
| Metronidazole + Lignocaine | Active comparator | Drug: Metronidazole and Lidocaine creamMetronidazole 10% + Lignocaine 4% |
| Metronidazole + Diltiazem + Lignocaine | Active comparator | Drug: Metronidazole, Diltiazem and Lidocaine creamMetronidazole 10% + Diltiazem 2% + Lignocaine 4% |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥16
- All patients undergoing excisional haemorrhoidectomy
Key exclusion criteria (12 listed)
- Age <16,
- history of chronic pain,
- drug allergy or idiosyncracies to any actives or excipients in
- cream,
- breastfeeding,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metronidazole cream10% metronidazole applied rectally | Drug | Metronidazole |
| Metronidazole and Diltiazem creamCombination Metronidazole and Diltiazem applied rectally | Drug | Metronidazole + Diltiazem |
| Metronidazole and Lidocaine creamCombination metronidazole and lignocaine applied rectally | Drug | Metronidazole + Lignocaine |
| Metronidazole, Diltiazem and Lidocaine creamCombination of all active agents tested applied rectally | Drug | Metronidazole + Diltiazem + Lignocaine |
Primary outcome
Pain scores
Time frame: 7 days
Measured by visual analog scale, 1-10cm, continuous, the higher the score, the worse the pain
Amount of analgesic use
Time frame: 7 days
Morphine equivalent amount
5 secondary outcomes
Return to work
Time frame: 14 days
Pain on bowel motion: Visual Analog Scale
Time frame: 7 days
Complications
Time frame: 30 days
Re-admission
Time frame: 30 days
Repeat Prescription
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 38871679Jin 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.
- Individual participant dataSharing planned: Yes. Will be shared when results become available.
Related trials for Hemorrhoid Pain
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Not yet recruiting
Laser Hemorrhoidoplasty Versus Open Hemorrhoidectomy for Postoperative Pain
Hemorrhoid
Recruiting
Sutureless Hemorrhoidectomy Versus Conventional Ligation in Advanced Hemorrhoids
Hemorrhoids
Not yet recruiting
Pudendal Nerve Block Techniques for Pain Control After Hemorrhoidectomy
Hemorrhoids, Postoperative Pain
Recruiting
HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids
Hemorrhoids Third Degree, Internal Hemorrhoids
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew G Hill, MBChB, MD, EdD, FRACS, FACS principal investigator
Counties Manukau Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Metronidazole cream, Metronidazole and Diltiazem cream and Metronidazole and Lidocaine cream in people with Hemorrhoid Pain and Hemorrhoids, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04276298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.