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

NCT05015907 | Completed

• 1 other identifier: H-2105-150-1222
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Pediatric

Keywords

selective supraclavicular nerve block; postoperative pain control; Hickman catheter; chemoport; Perm cath

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Pain score

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

• Pain score

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

• Additional narcotic analgesics administered

  Within 24 hours of the end of surgery

• Additionally administered non-narcotic analgesics

  Within 24 hours of the end of surgery

• Side effects related to pain medication

  Within 24 hours of the end of surgery

Study Arms (2)

Selective supraclavicular nerve block

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

The nerve block is not performed in the control group.

Other: Control (without intervention)

Interventions

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.

Selective supraclavicular nerve block

Control (without intervention) OTHER

No intervention

Control

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

Related Publications (1)

• Park JB, Song IS, Kang PY, Ji SH, Jang YE, Kim EH, Lee JH, Kim HS, Kim JT. Ultrasound-guided selective supraclavicular nerve block for postoperative pain control in children receiving Hickman catheter or chemoport insertion: A randomized controlled trial. Paediatr Anaesth. 2024 Jan;34(1):35-41. doi: 10.1111/pan.14745. Epub 2023 Aug 16.

  PMID: 37587734 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jin-Tae Kim, MD,PhD

  Seoul National University Hospital, Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 23, 2021
• Study Start: October 22, 2021
• Primary Completion: February 23, 2023
• Study Completion: February 24, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

KR (1)