RecruitingPhase 3ACTRN12618000713291

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


Sponsor

Instituto Português de Oncologia de Lisboa de Francisco Gentil, EPE

Enrollment

30 participants

Start Date

Jan 3, 2018

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria3

  • 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 Criteria5

  • 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

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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

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.


Locations(1)

Portugal

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