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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer Pediatric
• Intervention / Treatment: Drug: Ropivacaine; Other: Control (without intervention)

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Jin-Tae Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selective supraclavicular nerve block; 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; 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.
Active Comparator: Control; The nerve block is not performed in the control group.	Other: Control (without intervention); No intervention

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jin-Tae Kim, MD,PhD, Seoul National University Hospital, Seoul National University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): February 24, 2023

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 14, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: postoperative pain control; selective supraclavicular nerve block; Hickman catheter; chemoport; Perm cath
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: H-2105-150-1222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No