Cancer PediatricNCT05015907
Ultrasound-guided Selective Supraclavicular Nerve Block for Postoperative Pain Control in Pediatric Patients.
A study testing Ropivacaine in people with Cancer Pediatric, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cancer Pediatric
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Oct 2021to 24 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cancer Pediatric
- Being tested
- Ropivacaine, Control (without intervention)
- Keywords
- selective supraclavicular nerve block, postoperative pain control, Hickman catheter, chemoport, Perm cath
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Ropivacaine |
| Control | Active comparator | The nerve block is not performed in the control group. Receives: Other: Control (without intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Wong-Baker Faces Pain Rating Scale is used
Measured: 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
Measured: Pain score measured when communication is possible between 10 and 30 minutes after entering the recovery room.
Secondary outcomes (10)
Pain score
Wong-Baker Faces Pain Rating Scale is used
Measured: Pain score for 1 hour, 3 hours, and 24 hours after leaving the recovery room
Pain score
Numeric rating scale is also evaluated if communication is possible
Measured: Pain score for 1 hour, 3 hours, and 24 hours after leaving the recovery room
Additional narcotic analgesics administered
Amount per body weight of additional narcotic analgesics administered.
Measured: Within 24 hours of the end of surgery
Additionally administered non-narcotic analgesics
Amount per body weight of additionally administered non-narcotic analgesics.
Measured: Within 24 hours of the end of surgery
Side effects related to pain medication
Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation, etc.
Measured: Within 24 hours of the end of surgery
Complications related to ropivacaine use
Arrhythmia, Hypotension, ST change, Dizziness, Convulsion, etc.
Measured: Within 1 hour after procedure
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.
Measured: Within 24 hours of the end of surgery
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 %)].
Measured: Within 24 hours of the end of surgery
Hospital stay
The period from discharge from recovery room to discharge
Measured: No more than one month
Check the blockage
The quality of the selective supraclavicular nerve block will be tested with loss of cold sensation using an alcohol swab.
Measured: When communication is possible between 10 and 30 minutes after entering the recovery room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start22 Oct 2021
- Primary completion23 Feb 2023
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PediatricStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, MD,PhD, Principal investigator, Seoul National University Hospital, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015907
- Sponsor's protocol ID
- H-2105-150-1222
- Status last verified
- Feb 2023
- First submitted
- 5 Aug 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37587734
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05015907
- Acronym / sponsor ID
- H-2105-150-1222
- Conditions
- Cancer Pediatric
- Keywords
- selective supraclavicular nerve block, postoperative pain control, Hickman catheter, chemoport, Perm cath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective supraclavicular nerve block | Experimental | Drug: RopivacaineAfter 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). |
| Control | Active comparator | Other: Control (without intervention)The nerve block is not performed in the control group. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineThe 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. | Drug | Selective supraclavicular nerve block |
| Control (without intervention)No intervention | Other | Control |
Primary outcome
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
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
10 secondary outcomes
Pain score
Time frame: Pain score for 1 hour, 3 hours, and 24 hours after leaving the recovery room
Pain score
Time frame: Pain score for 1 hour, 3 hours, and 24 hours after leaving the recovery room
Additional narcotic analgesics administered
Time frame: Within 24 hours of the end of surgery
Additionally administered non-narcotic analgesics
Time frame: Within 24 hours of the end of surgery
Side effects related to pain medication
Time frame: Within 24 hours of the end of surgery
Complications related to ropivacaine use
Time frame: Within 1 hour after procedure
Whether diaphragmatic palsy
Time frame: Within 24 hours of the end of surgery
Whether diaphragmatic palsy
Time frame: Within 24 hours of the end of surgery
Hospital stay
Time frame: No more than one month
Check the blockage
Time frame: When communication is possible between 10 and 30 minutes after entering the recovery room.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 37587734Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Tae Kim, MD,PhD principal investigator
Seoul National University Hospital, Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in people with Cancer Pediatric, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: Pain score measured when communication is possible between 10 and 30 minutes after entering the recovery room.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05015907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.