None listed
Conditions
Brief summary
This study will allow to prospectively to evaluate whether there is a benefit (reduction of pain and decrease of systemic analgesia) in the use of ropivacaine in relation to the use of lidocaine in a cohort of patients with head and neck cancers in whom pain control is particularly important for quality of life and the humanization of care.
Interventions
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.
Sponsors
Instituto Português de Oncologia de Lisboa de Francisco Gentil, EPE
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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
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
Outcome results
None listed