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Completed

NCT Number: NCT05015907

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

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.

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Key information

Conditions

Cancer Pediatric Neoplasms

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jin-Tae Kim

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

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.

Control (without intervention)

Other

No intervention

Primary outcomes

  1. Pain score

    Time frame: Pain score measured when communication is possible between 10 and 30 minutes after entering the recovery room.

    Wong-Baker Faces Pain Rating Scale is used

  2. Pain score

    Time frame: 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 outcomes

  1. Pain score

    Time frame: Pain score for 1 hour, 3 hours, and 24 hours after leaving the recovery room

    Wong-Baker Faces Pain Rating Scale is used

  2. Pain score

    Time frame: 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

  3. Additional narcotic analgesics administered

    Time frame: Within 24 hours of the end of surgery

    Amount per body weight of additional narcotic analgesics administered.

  4. Additionally administered non-narcotic analgesics

    Time frame: Within 24 hours of the end of surgery

    Amount per body weight of additionally administered non-narcotic analgesics.

  5. Side effects related to pain medication

    Time frame: Within 24 hours of the end of surgery

    Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation, etc.

  6. Complications related to ropivacaine use

    Time frame: Within 1 hour after procedure

    Arrhythmia, Hypotension, ST change, Dizziness, Convulsion, etc.

  7. Whether diaphragmatic palsy

    Time frame: Within 24 hours of the end of surgery

    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.

  8. Whether diaphragmatic palsy

    Time frame: 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 %)].

  9. Hospital stay

    Time frame: No more than one month

    The period from discharge from recovery room to discharge

  10. Check the blockage

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2021
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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