Ultrasound-guided Selective Supraclavicular Nerve Block for Postoperative Pain Control in Pediatric Patients.

Study Overview
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Brief Summary
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This prospective randomized controlled trial aims to investigate the effect of ultrasound-guided selective supraclavicular nerve block on pain control after Hickman catheter, chemoport, or Perm cath insertion in children.

Detailed Description
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Pediatric patients undergoing surgical insertion of a Hickman catheter, chemoport, or Permcath are randomly assigned to a test group (Ultrasound-guided selective supraclavicular nerve block with Ropivacaine) and a control group (Nerve block is not performed). Immediately after induction of general anesthesia, in the test group, the supraclavicular nerve block was selectively performed using ultrasound using 0.1mL/kg of 0.5% Ropivacaine (Maximum dose: 5mL), and the nerve block was not completed in the control group. After that, a Hickman catheter, chemoport, or Permcath is surgically inserted in the usual way and allowed to recover from anesthesia. The pain score is evaluated between 10 and 30 minutes of entering the recovery room (1 hour after the procedure) and 1 hour, 3 hours, and 24 hours after leaving the recovery room by another research team who is unaware of the group assignment. In addition, the use of additional analgesic drugs and related side effects were collected before discharge.

Official Title
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Ultrasound-guided Selective Supraclavicular Nerve Block for Postoperative Pain Control in Pediatric Patients Receiving Hickman Catheter, Chemoport or Perm Cath Insertion : a Randomized Controlled Trial

Conditions
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Cancer Pediatric

Intervention / Treatment
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* Drug: Ropivacaine
* Other: Control (without intervention)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients receiving Hickman catheter, chemoport, or Perm cath implantation (3 years ≤, <18 years) One or more of the parents (or guardians), after hearing and understanding a sufficient explanation about this clinical trial, decides to participate voluntarily and agrees in writing to abide by the precautions In the case of a study subject aged seven years or older, a person who voluntarily decides to participate in this clinical trial and agrees in writing to abide by the precautions after hearing and understanding a sufficient explanation about this clinical trial Exclusion Criteria: Patients who undergo surgery other than the surgery. Patients with diseases whose sensitivity to pain is different from that of the general public Unstable vital signs (heart rate, blood pressure) General contraindications of Ropivacaine Patients with a history of allergy to opioids Severe renal dysfunction (Creatinine> 3.0 mg/dl) Severe liver dysfunction (aspartate transaminase > 120 unit/L, alanine aminotransferase > 120 unit/L) Peripheral nervous system abnormalities At risk of malignant hyperthermia Other cases that the researcher judges to be inappropriate

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selective supraclavicular nerve block<br>After induction of anesthesia, the anesthesiologist sterilizes the skin of the area to be punctured. In the test group, an Ultrasound-guided selective supraclavicular nerve block is performed using 0.5% Ropivacaine 0.1mL/kg (Maximum dose: 5mL). | Drug: Ropivacaine<br>* The nerve involved in the operation of Hickman catheter, chemoport, and Perm cath is the supraclavicular nerve. Therefore, it is judged that if only this nerve is selectively blocked, pain control can be effectively performed with a small amount of local anesthetic, and relatively few side effects occur.<br>|
| Active Comparator: Control<br>The nerve block is not performed in the control group. | Other: Control (without intervention)<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Wong-Baker Faces Pain Rating Scale is used | Pain score measured when communication is possible between 10 and 30 minutes after entering the recovery room. | 
| Pain score | Numeric rating scale is also evaluated if communication is possible | Pain score measured when communication is possible between 10 and 30 minutes after entering the recovery room. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Wong-Baker Faces Pain Rating Scale is used | Pain score for 1 hour, 3 hours, and 24 hours after leaving the recovery room | 
| Pain score | Numeric rating scale is also evaluated if communication is possible | Pain score for 1 hour, 3 hours, and 24 hours after leaving the recovery room | 
| Additional narcotic analgesics administered | Amount per body weight of additional narcotic analgesics administered. | Within 24 hours of the end of surgery | 
| Additionally administered non-narcotic analgesics | Amount per body weight of additionally administered non-narcotic analgesics. | Within 24 hours of the end of surgery | 
| Side effects related to pain medication | Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation, etc. | Within 24 hours of the end of surgery | 
| Complications related to ropivacaine use | Arrhythmia, Hypotension, ST change, Dizziness, Convulsion, etc. | Within 1 hour after procedure | 
| Whether diaphragmatic palsy | It is confirmed by chest X-ray taken in the operating room. Diaphragmatic palsy can usually be suspected on chest X-rays showing abnormal hemidiaphragm elevation. Therefore, we will check the chest X-ray for abnormal hemidiaphragm elevation. | Within 24 hours of the end of surgery | 
| Whether diaphragmatic palsy | It is confirmed by lung ultrasound in the recovery room. Hemidiaphragm visualization by ultrasound is achieved from an anterior approach, with the patient in a supine position. At the ultrasound, the diaphragm appears as a thick echogenic line. M-mode US may be used to measure the direction of diaphragmatic motion and the amplitude of excursion. The two indexes usually used for the diagnosis of diaphragmatic paralysis include a Tdi value <2 mm and a diaphragm thickening fraction (TFdi)value <20% [Tdi: The thickening of the diaphragm, TFdi: (thickness at the end of the inspiration - thickness at the end of expiration)/thickness at the end of expiration (in %)]. | Within 24 hours of the end of surgery | 
| Hospital stay | The period from discharge from recovery room to discharge | No more than one month | 
| Check the blockage | The quality of the selective supraclavicular nerve block will be tested with loss of cold sensation using an alcohol swab. | When communication is possible between 10 and 30 minutes after entering the recovery room. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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selective supraclavicular nerve block, postoperative pain control, Hickman catheter, chemoport, Perm cath