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

Cancer Pediatric Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05015907
• Other study ID #: H-2105-150-1222
• Status: Completed
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: February 24, 2023

Study information

• Verified date: February 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 24, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Pediatric
• Pain, Postoperative

Intervention

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.

Other:
• Control (without intervention)
No intervention

Locations

Country	Name	City	State
Korea, Republic of	Jin-Tae Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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
Secondary	Additional narcotic analgesics administered	Amount per body weight of additional narcotic analgesics administered.	Within 24 hours of the end of surgery
Secondary	Additionally administered non-narcotic analgesics	Amount per body weight of additionally administered non-narcotic analgesics.	Within 24 hours of the end of surgery
Secondary	Side effects related to pain medication	Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation, etc.	Within 24 hours of the end of surgery
Secondary	Complications related to ropivacaine use	Arrhythmia, Hypotension, ST change, Dizziness, Convulsion, etc.	Within 1 hour after procedure
Secondary	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
Secondary	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
Secondary	Hospital stay	The period from discharge from recovery room to discharge	No more than one month
Secondary	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.