Clinical trial NCT05015907: Ultrasound-guided Selective Supraclavicular Nerve Block for Postoperative Pain Control in Pediatric Patients.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Pediatric
Keywords: selective supraclavicular nerve block
postoperative pain control
Hickman catheter
chemoport
Perm cath
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score
timeFrame: Pain score measured when communication is possible between 10 and 30 minutes after entering the recovery room.
measure: Pain score
timeFrame: Pain score measured when communication is possible between 10 and 30 minutes after entering the recovery room.
Secondary outcomes:
measure: Pain score
timeFrame: Pain score for 1 hour, 3 hours, and 24 hours after leaving the recovery room
measure: Pain score
timeFrame: Pain score for 1 hour, 3 hours, and 24 hours after leaving the recovery room
measure: Additional narcotic analgesics administered
timeFrame: Within 24 hours of the end of surgery
measure: Additionally administered non-narcotic analgesics
timeFrame: Within 24 hours of the end of surgery
measure: Side effects related to pain medication
timeFrame: Within 24 hours of the end of surgery
measure: Complications related to ropivacaine use
timeFrame: Within 1 hour after procedure
measure: Whether diaphragmatic palsy
timeFrame: Within 24 hours of the end of surgery
measure: Whether diaphragmatic palsy
timeFrame: Within 24 hours of the end of surgery
measure: Hospital stay
timeFrame: No more than one month
measure: Check the blockage
timeFrame: When communication is possible between 10 and 30 minutes after entering the recovery room.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
affiliation: Seoul National University Hospital, Seoul National University College of Medicine
name: Jin-Tae Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: