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Trial registered on ANZCTR


Registration number
ACTRN12618000713291
Ethics application status
Approved
Date submitted
25/12/2017
Date registered
1/05/2018
Date last updated
1/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of local anesthesia in patients with head and neck tumors undergoing percutaneous endoscopic gastrostomy (PEG): Lidocaine versus ropivacaine - Prospective, randomized, double blind study
Scientific title
Efficacy and safety of local anesthesia in patients with head and neck tumors undergoing percutaneous endoscopic gastrostomy (PEG): Lidocaine versus ropivacaine - Prospective, randomized, double blind study
Secondary ID [1] 293678 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 306020 0
Head and Neck cancer patients 306021 0
Percutaneous endoscopic gastrostomy (PEG) 306022 0
Condition category
Condition code
Diet and Nutrition 305172 305172 0 0
Other diet and nutrition disorders
Cancer 305173 305173 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Local anesthesia of the PEG insertion site,with a total of 10 mls of local anesthetic (ropivacaine 0, 75% or lidocaine 2%) according to randomization.
The intervention group will receive ropivacaine with subcutaneous followed by intramuscular injections administred during PEG procedure, performed by the gastroenterologist performing the PEG procedure in the abdominal site.
Intervention code [1] 299945 0
Treatment: Drugs
Comparator / control treatment
Local anesthesia of the PEG insertion site,with a total of 10 mls of local anesthetic (lidocaine 2%) according to usual care, with subcutaneous followed by intramuscular injections administred during PEG procedure, performed by the gastroenterologist performing the PEG procedure in the abdominal site.
Control group
Active

Outcomes
Primary outcome [1] 304326 0
To compare the efficacy of local anesthesia using lidocaine (2%) or ropivacaine (0.75%) in the placement of percutaneous endoscopic gastrostomy (PEG) in patients with tumors of the head and neck, using a visual analog scale for pain at PEG site in the first 24h after PEG procedure.
Timepoint [1] 304326 0
24h after procedure
Secondary outcome [1] 341586 0
The composite secondary outcome of usage of systemic analgesia after PEG placement will be assessed by: the number, the timing and the doses of systemic analgesia in the first 24h after PEG placement, using hospital records.
Timepoint [1] 341586 0
24 h after procedure
Secondary outcome [2] 343244 0
The composite secondary outcome of safety of PEG placement using ropivacaine, will be assed by registration of complications and mortality 30 days after PEG procedure, using hospital records.
Timepoint [2] 343244 0
30 days after procedure

Eligibility
Key inclusion criteria
Patients with head and neck tumors referedfor PEG placement without systemic analgesic therapy prior to PEG placement
Age 18 years old or older
Ability to provide informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal of the patient
Inability to provide informed consent
Use of systemic analgesics prior to PEG placement
Contraindications for PEG placement (patients unable to take PEG, chronic liver disease, presence of ascites, thrombocytopenia (<50,000 platelets), coagulopathy (INR> 1.5).
Allergy to lidocaine, ropivacaine, paracetamol, metamizole magnesium or any of its components and excipients

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/01/2018
Date of last participant enrolment
Anticipated
21/08/2018
Actual
Date of last data collection
Anticipated
21/08/2018
Actual
Sample size
Target
30
Accrual to date
27
Final
Recruitment outside Australia
Country [1] 9466 0
Portugal
State/province [1] 9466 0

Funding & Sponsors
Funding source category [1] 298297 0
Other Collaborative groups
Name [1] 298297 0
Instituto Português de Oncologia de Lisboa de Francisco Gentil, EPE
Country [1] 298297 0
Portugal
Primary sponsor type
Other Collaborative groups
Name
Instituto Português de Oncologia de Lisboa de Francisco Gentil, EPE
Address
Instituto Português de Oncologia de Lisboa de Francisco Gentil, EPE
Gastroenterology Department
Rua Prof Lima Basto
1099-023 Lisboa
Country
Portugal
Secondary sponsor category [1] 297412 0
Individual
Name [1] 297412 0
Luis Medeiros
Address [1] 297412 0
Instituto Português de Oncologia de Lisboa de Francisco Gentil, EPE
Anesthesiology Department
Rua Prof Lima Basto
1099-023 Lisboa
Country [1] 297412 0
Portugal

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299297 0
Comissão de Ética para Saúde do Instituto Português de Oncologia de Lisboa
Ethics committee address [1] 299297 0
Ethics committee country [1] 299297 0
Portugal
Date submitted for ethics approval [1] 299297 0
Approval date [1] 299297 0
06/01/2017
Ethics approval number [1] 299297 0
UIC/1083

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79954 0
Dr Sandra Faias
Address 79954 0
Instituto Português de Oncologia de Lisboa de Francisco Gentil, EPE
Gastroenterology Department
Rua Prof Lima Basto
1099-021 Lisboa
Country 79954 0
Portugal
Phone 79954 0
+351914310209
Fax 79954 0
Email 79954 0
sandrarfaias@hotmail.com
Contact person for public queries
Name 79955 0
Sandra Faias
Address 79955 0
Instituto Português de Oncologia de Lisboa de Francisco Gentil, EPE
Gastroenterology Department
Rua Prof Lima Basto
1099-021 Lisboa
Country 79955 0
Portugal
Phone 79955 0
+351914310209
Fax 79955 0
Email 79955 0
sandrarfaias@hotmail.com
Contact person for scientific queries
Name 79956 0
Sandra Faias
Address 79956 0
Instituto Português de Oncologia de Lisboa de Francisco Gentil, EPE
Gastroenterology Department
Rua Prof Lima Basto
1099-021 Lisboa
Country 79956 0
Portugal
Phone 79956 0
+351914310209
Fax 79956 0
Email 79956 0
sandrarfaias@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.