An interventional study of TAP Block and LIA local infiltration in Appendectomy, Laparoscopy and Anesthesia, Conduction, sponsored by Ospedale di Circolo - Fondazione Macchi. Status unknown at 1 site in Italy. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-03-04.
Sponsored by Ospedale di Circolo - Fondazione Macchi · Not applicable, Interventional, and Treatment
Effectiveness of the TAP block compared to wound infiltration in controlling pain after laparoscopic appendectomy in children
Laparoscopic appendectomy is one of the main emergency surgical procedures performed in children.
The available local anesthesia techniques include wound infiltration or "wall" blocks such as the TAP (transversus abdominis plane) block.
The greater evidence on the adult population suggests that both techniques are valid for pain control in the immediate postoperative period, although wall blocks can guarantee a more prolonged analgesic effect over time.
The evidence on the pediatric population, on the other hand, is less strong and sometimes conflicting: therefore, the objective of our study is to verify the efficacy of TAP block compared to wound infiltration in the control of postoperative pain after appendectomy in pediatric patients.
Ospedale di Circolo - Fondazione Macchi is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side.
Procedure: TAP Block · Procedure: General anesthesia · Drug: Postperative analgesia
Wound infiltration with 0,5% levobupivacaine 1.5 mg/kg
Procedure: LIA local infiltration · Procedure: General anesthesia · Drug: Postperative analgesia
At the end of surgery patients will receive bilateral ultrasound-guided single-shot TAP block: 0,15% levobupivacaine 0,75 mg/kg per side will be injected between internal oblique and transveralis fascia
At the end of surgery 0,5% levobupivacaine 1.5 mg/kg, equally distributed between ports, injected in the skin and subcutaneous tissue during wound closure.
General anesthesia will be induced with fentanyl 1,5 mcg/kg, propofol 2 mg/kg, rocuronium 0,6 mg/kg; after intubation anesthesia will be mantained with sevoflurane (MAC 1). 30 minutes after induction will be administered paracetamol 15 mg/kg iv.
During first 48 hours after surgery all patients wil receive paracetamol 15 mg/kg iv every 8 hours and ibuprofen 10 mg/kg orally (or through gastric tube) every 12 hours after surgery. In case of severe pain tramadol 0,5 mg/kg will be administered iv every 8 hours.
Postoperative pain at 2 hours
Difference in pain severity (assessed by Wong Baker for under 8 year and visual analog scale dor older than 8) of TAP block goup compared to wound infiltration group 2 hours after the end of the surgery.
Time frame: 2 hours
Postoperative pain at 4-12-24 hours
Difference in pain severity (assessed by Wong Baker for under 8 year and visual analog scale dor older than 8) of TAP block goup compared to wound infiltration group 4 hours, 12 hours and 24 hours from the end of the surgery.
Time frame: from 4 to 24 postoperative hours
Total opioid consumption
Differences in tramadol rescue use (expressed in mg/kg) in the TAP group compared to the LIA group
Time frame: from 2 to 24 postoperative hours
time to first opioid analgesic rescue
Differences in the elapsed time before first request for tramadol rescue in the TAP group compared to the LIA group
Time frame: from 2 to 24 postoperative hours
Side effects
Differences in the incidence of side effects depending on the anesthetic technique adopted
Time frame: from 2 to 24 postoperative hours
Start is estimated for Mar 2020; primary completion for Apr 2020, 1 month later.
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Ospedale di Circolo - Fondazione Macchi