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Trial registered on ANZCTR


Registration number
ACTRN12622000006741
Ethics application status
Approved
Date submitted
6/10/2021
Date registered
11/01/2022
Date last updated
18/01/2023
Date data sharing statement initially provided
11/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
PLATIPUS Trial: comparison of different pain relief strategies in haemorrhoid banding
Scientific title
Local anaesthetic infiltration after rubber band ligation of rectal haemorrhoids: study protocol for a three-arm, double-blind randomised controlled trial (PLATIPUS trial)
Secondary ID [1] 305475 0
None
Universal Trial Number (UTN)
Trial acronym
PLATIPUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemorrhoids 323856 0
Condition category
Condition code
Oral and Gastrointestinal 321366 321366 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a three-arm trial comparing submucosal local anaesthetic (LA) infiltration, pudendal nerve block (PNB) and standard care for analgesia in haemorrhoid banding.

Participants in the submucosal LA group will receive 1-2 mL of 0.5% bupivacaine with adrenaline (1:200,000) 2.5 mg/mL injected in the submucosal plane just proximal to the placement of the rubber band, intra-procedure, immediately prior to placement of the band.

Participants in the PNB group will receive 20mL ropivacaine 1% 10mg/mL injected at the pudendal nerve on the ipsilateral side of the haemorrhoid to be banded, administered using anatomic landmarks, intra-procedure, immediately prior to placement of the band (if haemorrhoid disease is bilateral, then the block will be administered bilaterally). To standardise technique, the nerve block will be administered with the aid of an instructional video, which will be distributed to all participating proceduralists.

All proceduralists will be consultant surgeons experienced in the administration of local anaesthetic in colorectal procedures. The rubber band ligation procedure typically takes 5-10 minutes, depending on the number of haemorrhoids to be banded and the severity of the disease.

Participants' operation reports and/or medical records will be reviewed to monitor adherence to the administration of the anaesthetic agent - all anaesthetic techniques used in any procedure are routinely documented in medical records.

Both these interventions are routinely used at the participating study sites in RBL procedures. The decision to opt for one analgesic strategy over another for an isolated RBL procedure in the population eligible for this study is proceduralist dependent; therein lies the clinical equipoise for this study. Accordingly, this trial does not involve the use of unapproved therapeutic goods or procedures.
Intervention code [1] 321878 0
Treatment: Drugs
Comparator / control treatment
Participants in the control ('standard care') group will receive no LA injections. All participants will have access to routine intra- and post-procedural systemic opioid and non-opioid analgesia, administered via the intravenous or oral route, by either the treating anaesthetist, nursing staff or patient, as appropriate.
Control group
Active

Outcomes
Primary outcome [1] 329144 0
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.
Timepoint [1] 329144 0
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.
Secondary outcome [1] 401626 0
Use of post-procedural systemic opioid and non-opioid analgesia. This information will be obtained from the routinely used medication administration charts on the hospitals’ electronic medical records system.
Timepoint [1] 401626 0
During the immediate post-procedural period, prior to participants' discharge from hospital (typically <2 hours post procedure).
Secondary outcome [2] 401627 0
Time to discharge from hospital post procedure (in minutes). This information will be obtained from the hospitals' electronic medical records system, which routinely records the procedure finish time and discharge time of all patients.
Timepoint [2] 401627 0
At the time that participants are discharged from hospital.
Secondary outcome [3] 417653 0
Participant satisfaction with the haemorrhoid banding procedure. This will be assessed on a 5-point Likert scale at the two-week follow-up phone call.
Timepoint [3] 417653 0
At the two-week follow-up phone call.
Secondary outcome [4] 417654 0
Days until return to work or usual activities. Participants will be asked how many days it took them to return to work or usual activities following their procedure at the two-week follow-up phone call.
Timepoint [4] 417654 0
At the two-week follow-up phone call.
Secondary outcome [5] 417655 0
Procedure associated complications. Complication data will be collected via medical records and follow-up phone calls.
Timepoint [5] 417655 0
During the post-procedural period, up until 2 weeks post procedure.

Eligibility
Key inclusion criteria
The inclusion criteria for this study are:
- Adults aged 18 years or older, AND
- Consented for rubber band ligation of haemorrhoid disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will occur using sealed opaque envelopes.

The randomisation sequence used to allocate participants to treatment groups will be documented in sequentially numbered, opaque sealed envelopes, by an independent investigator not involved in other study activities. At the time that investigators recruit participants for the study - prior to their rubber band ligation procedure - they will attach a sealed envelope to the procedure consent form. Then, at the time of the procedure, the proceduralist will open the envelope to determine which study group the participant has been allocated to (and therefore, which anaesthetic intervention needs to be administered - if any).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation sequence will be prospectively generated with online software (sealedenvelope.com), using permuted blocks of 9 with an allocation ratio of 1:1:1.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
11/04/2022
Date of last participant enrolment
Anticipated
30/04/2023
Actual
Date of last data collection
Anticipated
14/05/2023
Actual
Sample size
Target
120
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 309831 0
Hospital
Name [1] 309831 0
Austin Hospital
Country [1] 309831 0
Australia
Primary sponsor type
Individual
Name
Mr David Proud
Address
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084
Country
Australia
Secondary sponsor category [1] 311332 0
None
Name [1] 311332 0
Address [1] 311332 0
Country [1] 311332 0
Other collaborator category [1] 282012 0
Individual
Name [1] 282012 0
Dr Eleanor Watson
Address [1] 282012 0
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084
Country [1] 282012 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309573 0
Austin Health HREC
Ethics committee address [1] 309573 0
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084
Ethics committee country [1] 309573 0
Australia
Date submitted for ethics approval [1] 309573 0
07/10/2021
Approval date [1] 309573 0
08/03/2022
Ethics approval number [1] 309573 0
Ethics committee name [2] 312265 0
Austin Health Human Research Ethics Committee
Ethics committee address [2] 312265 0
145 Studley Road
Heidelberg
VIC 3084
Ethics committee country [2] 312265 0
Australia
Date submitted for ethics approval [2] 312265 0
07/10/2021
Approval date [2] 312265 0
08/03/2022
Ethics approval number [2] 312265 0
HREC/79506/Austin-2021

Summary
Brief summary
Haemorrhoids are enlarged veins in the anus or lower rectum, which can cause bleeding, itching, pain and prolapse outside of the anal canal. The disease is commonly managed using rubber band ligation (RBL), where a band is placed around the base of the haemorrhoid, preventing blood flow to the haemorrhoid and causing it to fall off and pass through the anal canal. The most common complication of RBL is pain. Currently, surgeons vary widely in their approach to preventing pain in these patients, owing to a lack of quality evidence supporting one strategy over another. Surgeons may inject local anaesthetic at the site where the band is placed, or use it to block the nerve supplying the anus and lower rectum. Some patients receive no local anaesthetic, and rely on standard postoperative medications such as paracetamol, anti-inflammatories, and opioids. There is a need for quality research to determine the best strategy for pain management in patients undergoing this common procedure. In our study, participants undergoing RBL will be randomly assigned to receive either local anaesthetic at the banding site, a nerve block, or standard postoperative medications only. These pain management strategies are all routinely used in practice and are safe procedures common in many operations. At several timepoints following the procedure, participants will be asked to report their pain on a scale (up until 2 weeks post procedure). Participants’ use of pain medications in recovery; the time taken for participants to be discharged after their procedure; participant satisfaction with their procedure; the time it takes for participants to return to work after their procedure; and procedure associated complications, will also be recorded. These outcomes will then be used to determine which strategy is best for managing pain in patients undergoing RBL. We hypothesise that both pudendal nerve block and submucosal infiltration of local anaesthetic will be superior to no local anaesthetic for post-procedural pain management.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114634 0
Mr David Proud
Address 114634 0
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084
Country 114634 0
Australia
Phone 114634 0
+61 03 9496 4099
Fax 114634 0
Email 114634 0
haemorrhoidbanding@gmail.com
Contact person for public queries
Name 114635 0
Dr Eleanor Watson
Address 114635 0
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084
Country 114635 0
Australia
Phone 114635 0
+61 3 9496 5000
Fax 114635 0
Email 114635 0
haemorrhoidbanding@gmail.com
Contact person for scientific queries
Name 114636 0
Dr Eleanor Watson
Address 114636 0
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084
Country 114636 0
Australia
Phone 114636 0
+61 3 9496 5000
Fax 114636 0
Email 114636 0
haemorrhoidbanding@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect the privacy of participants.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13444Study protocol    This document may be obtained upon request to the ... [More Details]
13445Informed consent form    This document may be obtained upon request to the ... [More Details]
13446Clinical study report    This document may be obtained upon request to the ... [More Details]
13447Ethical approval    This document may be obtained upon request to the ... [More Details]
13448Statistical analysis plan    This document may be obtained upon request to the ... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLocal anaesthetic infiltration in rubber band ligation of rectal haemorrhoids: study protocol for a three-arm, double-blind randomised controlled trial (PLATIPUS trial).2023https://dx.doi.org/10.1136/bmjopen-2022-067896
N.B. These documents automatically identified may not have been verified by the study sponsor.