Back to resultsUltrasound-guided Selective Supraclavicular Nerve Block for Postoperative Pain Control in Pediatric Patients.
Primary Purpose
Cancer Pediatric
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ropivacaine
Control (without intervention)
Sponsored by
About this trial
This is an interventional treatment trial for Cancer Pediatric focused on measuring selective supraclavicular nerve block, postoperative pain control, Hickman catheter, chemoport, Perm cath
Eligibility Criteria
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
Sites / Locations
- Jin-Tae Kim
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Selective supraclavicular nerve block
Control
Arm 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).
The nerve block is not performed in the control group.
Outcomes
Primary Outcome Measures
Pain score
Wong-Baker Faces Pain Rating Scale is used
Pain score
Numeric rating scale is also evaluated if communication is possible
Secondary Outcome Measures
Pain score
Wong-Baker Faces Pain Rating Scale is used
Pain score
Numeric rating scale is also evaluated if communication is possible
Additional narcotic analgesics administered
Amount per body weight of additional narcotic analgesics administered.
Additionally administered non-narcotic analgesics
Amount per body weight of additionally administered non-narcotic analgesics.
Side effects related to pain medication
Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation, etc.
Complications related to ropivacaine use
Arrhythmia, Hypotension, ST change, Dizziness, Convulsion, etc.
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.
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 %)].
Hospital stay
The period from discharge from recovery room to discharge
Check the blockage
The quality of the selective supraclavicular nerve block will be tested with loss of cold sensation using an alcohol swab.
Full Information
NCT ID
NCT05015907
First Posted
August 5, 2021
Last Updated
February 27, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05015907
Brief Title
Ultrasound-guided Selective Supraclavicular Nerve Block for Postoperative Pain Control in Pediatric Patients.
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
February 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pediatric
Keywords
selective supraclavicular nerve block, postoperative pain control, Hickman catheter, chemoport, Perm cath
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Selective supraclavicular nerve block
Arm Type
Experimental
Arm 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).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The nerve block is not performed in the control group.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control (without intervention)
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Pain score
Description
Wong-Baker Faces Pain Rating Scale is used
Time Frame
Pain score measured when communication is possible between 10 and 30 minutes after entering the recovery room.
Title
Pain score
Description
Numeric rating scale is also evaluated if communication is possible
Time Frame
Pain score measured when communication is possible between 10 and 30 minutes after entering the recovery room.
Secondary Outcome Measure Information:
Title
Pain score
Description
Wong-Baker Faces Pain Rating Scale is used
Time Frame
Pain score for 1 hour, 3 hours, and 24 hours after leaving the recovery room
Title
Pain score
Description
Numeric rating scale is also evaluated if communication is possible
Time Frame
Pain score for 1 hour, 3 hours, and 24 hours after leaving the recovery room
Title
Additional narcotic analgesics administered
Description
Amount per body weight of additional narcotic analgesics administered.
Time Frame
Within 24 hours of the end of surgery
Title
Additionally administered non-narcotic analgesics
Description
Amount per body weight of additionally administered non-narcotic analgesics.
Time Frame
Within 24 hours of the end of surgery
Title
Side effects related to pain medication
Description
Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation, etc.
Time Frame
Within 24 hours of the end of surgery
Title
Complications related to ropivacaine use
Description
Arrhythmia, Hypotension, ST change, Dizziness, Convulsion, etc.
Time Frame
Within 1 hour after procedure
Title
Whether diaphragmatic palsy
Description
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.
Time Frame
Within 24 hours of the end of surgery
Title
Whether diaphragmatic palsy
Description
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 %)].
Time Frame
Within 24 hours of the end of surgery
Title
Hospital stay
Description
The period from discharge from recovery room to discharge
Time Frame
No more than one month
Title
Check the blockage
Description
The quality of the selective supraclavicular nerve block will be tested with loss of cold sensation using an alcohol swab.
Time Frame
When communication is possible between 10 and 30 minutes after entering the recovery room.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, MD,PhD
Organizational Affiliation
Seoul National University Hospital, Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jin-Tae Kim
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Ultrasound-guided Selective Supraclavicular Nerve Block for Postoperative Pain Control in Pediatric Patients.
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