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

Seoul National University

Status: Completed

Conditions: Cancer Pediatric

Treatments: Other: Control (without intervention); Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05015907

H-2105-150-1222

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Selective supraclavicular nerve block

Experimental group

Description:

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).

Treatment:

Drug: Ropivacaine

Control

Active Comparator group

Description:

The nerve block is not performed in the control group.

Treatment:

Other: Control (without intervention)