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

Plain Language Summary

Simplified for easier understanding

People with head and neck cancers often have difficulty swallowing, which can make eating and maintaining nutrition very challenging during cancer treatment. A feeding tube placed directly into the stomach through the abdomen — called a PEG (percutaneous endoscopic gastrostomy) tube — is a common solution. The procedure to insert the tube involves local anaesthetic injected into the skin, and the choice of anaesthetic drug can affect how much pain a patient feels during and after the procedure. This study is comparing two local anaesthetic drugs — lidocaine (the current standard) and ropivacaine (a longer-acting alternative) — to see which provides better pain relief during and after PEG tube insertion. Good pain control is especially important for head and neck cancer patients, who often already have significant discomfort, and reducing pain improves the overall quality of care. You may be eligible if you have a head or neck tumour and have been referred for PEG tube placement, are 18 to 80 years old, have not been taking regular pain medication before the procedure, and are able to give informed consent. People with allergies to either anaesthetic drug, significant liver disease, very low platelet counts, or conditions preventing PEG placement would not be eligible. The study is conducted at the Portuguese Institute of Oncology in Lisbon.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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