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

Not Applicable

Completed

• Conditions: Cancer Pediatric
• Interventions: Other: Control (without intervention); Drug: Ropivacaine

• Registration Number: NCT05015907
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-08-14
• Study First Posted: 2021-08-23
• Study Start: 2021-10-22
• Status Verified: 2023-02
• Primary Completion: 2023-02-23
• Study Completion: 2023-02-24
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control (without intervention)	The nerve block is not performed in the control group.
Selective supraclavicular nerve block	Ropivacaine	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).

Primary Outcome Measures

Name	Time	Method
Pain score	Pain score measured when communication is possible between 10 and 30 minutes after entering the recovery room.	Numeric rating scale is also evaluated if communication is possible

Secondary Outcome Measures

Name	Time	Method
Hospital stay	No more than one month	The period from discharge from recovery room to discharge
Pain score	Pain score for 1 hour, 3 hours, and 24 hours after leaving the recovery room	Numeric rating scale is also evaluated if communication is possible
Whether diaphragmatic palsy	Within 24 hours of the end of surgery	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% \[Tdi: The thickening of the diaphragm, TFdi: (thickness at the end of the inspiration - thickness at the end of expiration)/thickness at the end of expiration (in %)\].
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.
Complications related to ropivacaine use	Within 1 hour after procedure	Arrhythmia, Hypotension, ST change, Dizziness, Convulsion, etc.
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.

Trial Locations

Locations (1)

Jin-Tae Kim; 🇰🇷 Seoul, Korea, Republic of