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

• Register: ANZCTR
• Last refreshed on: 15 July 2019
• Main ID: ACTRN12618000713291
• Date of registration: 01/05/2018
• Prospective Registration: No
• Primary sponsor: Instituto Português de Oncologia de Lisboa de Francisco Gentil, EPE
• 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
• Date of first enrolment: 03/01/2018
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12618000713291.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 3

Countries of recruitment

Portugal

Contacts

• Name: Dr Sandra Faias

• Name: Dr Sandra Faias

Key inclusion & exclusion criteria

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





Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer;Head and Neck cancer patients;Percutaneous endoscopic gastrostomy (PEG);
Cancer
Head and Neck cancer patients
Percutaneous endoscopic gastrostomy (PEG)

Cancer - Head and neck

Diet and Nutrition - Other diet and nutrition disorders

Intervention(s)

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.

Primary Outcome(s)

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.


[24h after procedure]

Secondary Outcome(s)

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.[30 days after procedure]

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.[24 h after procedure]

Secondary ID(s)

none

Source(s) of Monetary Support

Instituto Português de Oncologia de Lisboa de Francisco Gentil, EPE

Secondary Sponsor(s)

Luis Medeiros

Ethics review

Status: Approved
Approval date:
Contact:

Comissão de Ética para Saúde do Instituto Português de Oncologia de Lisboa