Is botulinum toxin injection better than corticosteroid injection in the management of persistent post-surgical pain

Start 5 Dec 2024 · Status Temporarily halted · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Temporarily halted

Participants planned 60

Countries 1

Sites 1

Post-surgical scar pain

Test the null hypothesis that Botox is inferior to corticosteroids in treating post-surgical scar pain

Key facts

Sponsor: Mater Misericordiae University Hospital
Participant type: Healthy volunteers, Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Trial duration: 5 Dec 2024 → ongoing
Decision date (initial): 2024-12-05
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: Department of Pain Medicine, mater misericordae university hospital, Ireland

External identifiers

EU CT number: 2024-518954-18-01
EudraCT number: 2021-004575-14

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

Test the null hypothesis that Botox is inferior to corticosteroids in
treating post-surgical scar pain

Secondary objectives 1

This study will test the hypothesis that Botox will lead to improved pain scores and quality of life scores in persistent post-surgical pain patients.

Conditions and MedDRA coding

Post-surgical scar pain

Regulatory references

Plan to share IPD: No

EU CT number	Title	Sponsor
2024-518954-18-00	Efficacy of botulinum toxin vs corticosteroid in the management of persistent post-surgical scar pain	Mater Misericordiae University Hospital

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

Male and Female patients over 18 years of age with a diagnosis of persistent post-surgical pain (pain lasting more than 3 months after the original surgical treatment) who attend the pain clinic outpatient department in MMUH that can provide written informed consent.

Exclusion criteria 1

Absence of informed written consent, pre-existing infection at block site, severe coagulopathy, allergy to local anaesthesia, pre-existing dementia [because of need to co-operate in completing questionnaires after the procedure].

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Numerical rating scale of pain (NRS)

Secondary endpoints 1

b. Brief pain inventory score (short form) (BPI-sf) c. Pain self-efficacy questionnaire (PSEQ) d. Documentation of any adverse events e. Patients global impression of change (PGIC)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

BOTOX 100 Allergan Units Powder for Solution for Injection

PRD9814936 · Product

Active substance: Botulinum Toxin Type A
Substance synonyms: Onaclostox, Botulinum toxin, type A, purified neurotoxin component, OnabotulinumtoxinA, BOTULINUM TOXIN A, BOTULIN TOXIN A
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRADERMAL USE
Max daily dose: 100 IU international unit(s)
Max total dose: 100 IU international unit(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: M03AX01 — BOTULINUM TOXIN
Marketing authorisation: PA 1824/17/1
MA holder: ABBVIE LIMITED
MA country: Ireland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 1

Adcortyl™ Intra-articular / Intradermal Injection 10 mg/ml, Suspension for Injection, 5 ml

PRD325660 · Product

Active substance: Triamcinolone Acetonide
Pharmaceutical form: SUSPENSION FOR INJECTION
Route of administration: INTRADERMAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: H02AB08 — TRIAMCINOLONE
Marketing authorisation: PA 0002/018/003
MA holder: BRISTOL-MYERS SQUIBB PHARMACEUTICALS UNLIMITED COMPANY
MA country: Ireland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Auxiliary 1

Bupivacaine 2.5mg/ml Solution for Injection

PRD6281300 · Product

Active substance: Bupivacaine Hydrochloride Monohydrate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRADERMAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: N01BB01 — BUPIVACAINE
Marketing authorisation: PA 2299/035/001
MA holder: BAXTER HOLDING B.V.
MA country: Ireland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Mater Misericordiae University Hospital

Sponsor organisation: Mater Misericordiae University Hospital
Address: Eccles Street
City: Dublin 7
Postcode: D07 R2WY
Country: Ireland

Scientific contact point

Organisation: Mater Misericordiae University Hospital
Contact name: Dr Conor Hearty

Public contact point

Organisation: Mater Misericordiae University Hospital
Contact name: Sponsor

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Ireland	Temporarily halted	60	1
Rest of world	—	0	—

Investigational sites

Ireland

1 site · Temporarily halted

Mater Misericordiae University Hospital

Pain Medicine, Eccles Street, D07 R2WY, Dublin 7

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Ireland	2024-12-05

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Temporary halt TH-136994

Halt date: 2026-06-02
Member states concerned: Ireland
Publication date: 2026-06-02
Reason: Sponsor decision, Investigator/Site related
Benefit-risk balance changed: No
Treatment stopped: No

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	HPRA Botox Protocol v1-2 corrected1	1
Recruitment arrangements (for publication)	recrutiment arrangement	1
Subject information and informed consent form (for publication)	mater PIL Botox corrected1	1
Summary of Product Characteristics (SmPC) (for publication)	SmpC Botox	1
Summary of Product Characteristics (SmPC) (for publication)	SmpC Triamcinalone	1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-11-24	Ireland	Acceptable 2024-12-05	2024-12-05