Cancer Pediatric
Conditions
Keywords
selective supraclavicular nerve block, postoperative pain control, Hickman catheter, chemoport, Perm cath
Brief summary
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
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.
Interventions
DRUGRopivacaine
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.
OTHERControl (without intervention)
No intervention
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | Pain score measured when communication is possible between 10 and 30 minutes after entering the recovery room. | Wong-Baker Faces Pain Rating Scale is used |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional narcotic analgesics administered | Within 24 hours of the end of surgery | Amount per body weight of additional narcotic analgesics administered. |
| Additionally administered non-narcotic analgesics | Within 24 hours of the end of surgery | Amount per body weight of additionally administered non-narcotic analgesics. |
| Side effects related to pain medication | Within 24 hours of the end of surgery | Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation, etc. |
| Pain score | Pain score for 1 hour, 3 hours, and 24 hours after leaving the recovery room | Wong-Baker Faces Pain Rating Scale is used |
| Whether diaphragmatic palsy | Within 24 hours of the end of surgery | 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. |
| Hospital stay | No more than one month | The period from discharge from recovery room to discharge |
| Check the blockage | When communication is possible between 10 and 30 minutes after entering the recovery room. | The quality of the selective supraclavicular nerve block will be tested with loss of cold sensation using an alcohol swab. |
| Complications related to ropivacaine use | Within 1 hour after procedure | Arrhythmia, Hypotension, ST change, Dizziness, Convulsion, etc. |
Countries
South Korea
Outcome results
None listed