Anesthesia, LocalNCT04786756
Comparison of Lateral and Medial Approaches to Costoclavicular Brachial Plexus Block in Pediatrics
A study testing Bupivacaine 0.25% Injectable Solution in people with Anesthesia, Local and Postoperative Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery. In this study, we aim to compare the different approaches of US guided costoclavicular technique. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local, Postoperative Pain
- What is being tested?
- Bupivacaine 0.25% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 27 Dec 2021
- 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 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Undergoing unilateral upper extremity surgery (distal midhumerus).
- ASA(American Society of Anesthesiology) 1-3
- Receiving family consent from the parents that they accept regional analgesia
Who cannot join
- Parents refusal
- Infection on the local anesthetic application area
- Infection in the central nervous system
- Coagulopathy
- Brain tumors
- Known allergy against local anesthetics
- Anatomical difficulties
- Syndromic patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultrasound-Guided Lateral and Medial Approaches to Costoclavicular Brachial Plexus Block in Pediatric Patients Undergoing Unilateral Upper Exremity Surgery: A Randomized Controlled Double-Blinded Study
In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery. In this study, we aim to compare the different approaches of US guided costoclavicular technique. Lateral approache is more common for the costoclavicular block area. However, more needle maneuvers are needed especially in pediatric patients because of the coracoid process. Medial approach is recommended to overcome this problem. Thus demonstrate the safety of upper extremity blocks, which is an important part of multimodal analgesia, and to determine the most ideal technique in the pediatric patient group who will undergo upper extremity surgery.
During the block application, the US imaging time, the difficulty level of needle imaging, the number of maneuvers required to reach the target image, whether additional maneuvers are required according to the local anesthetic distribution, the success of the block and the duration of the surgery, the total application time of the block and the duration of general anesthesia will be recorded. Mean arterial pressure and heart rate will be recorded at 30-minute intervals during the surgery. Standardized for pediatric patients The FLACC and Wong-Baker pain scores will be followed first 24 hours after surgery. The patient will be examined for motor and sensation, and analgesic doses will be recorded if used. Time to first pain identification, duration of sleep, patient and surgeon satisfaction will be recorded.
Read the detailed description
Peripheral nerve blocks; It is widely used in daily practice for anesthesia or as a part of multimodal analgesia in most surgical procedures. In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery. In this study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients. In this study, we aim to compare the different approaches of US guided costoclavicular technique. Lateral approache is more common for the costoclavicular block area. However, more needle maneuvers are needed especially in pediatric patients because of the coracoid process. Medial approach is recommended to overcome this problem. Thus demonstrate the safety of upper extremity blocks, which is an important part of multimodal analgesia, and to determine the most ideal technique in the pediatric patient group who will undergo upper extremity surgery.
During the block application, the US imaging time, the difficulty level of needle imaging, the number of maneuvers required to reach the target image, whether additional maneuvers are required according to the local anesthetic distribution, the success of the block and the duration of the surgery, the total application time of the block and the duration of general anesthesia will be recorded. Mean arterial pressure and heart rate will be recorded at 30-minute intervals during the surgery. Standardized for pediatric patients The FLACC and Wong-Baker pain scores will be followed first 24 hours after surgery. The patient will be examined for motor and sensation, and analgesic doses will be recorded if used. Time to first pain identification, duration of sleep, patient and surgeon satisfaction will be recorded.
- Conditions
- Anesthesia, Local, Postoperative Pain
- Being tested
- Bupivacaine 0.25% Injectable Solution
- Keywords
- Postoperative Analgesia, Upper Extremity Surgery, Costoclavicular Block, Brachial Plexus Block, Ultrasound Guidance
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25% Injectable SolutionDrug
Also called Marcaine
1 mg/kg Bupivacaine (0.25%)
| Study group | Role | What they receive |
|---|---|---|
| Lateral Approach of Costoclavicular Block | Active comparator | US-guided lateral approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25) Receives: Drug: Bupivacaine 0.25% Injectable Solution |
| Medial Approach of Costoclavicular Block | Active comparator | US-guided medial approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25) Receives: Drug: Bupivacaine 0.25% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of needle maneuvers
Number of needle maneuvers according to local anesthetic distribution
Measured: Up to 15 minutes
Secondary outcomes (15)
Ideal USG guided brachial plexus cords visualization/needle pathway planning time
Practitioner's ideal image acquisition time
Measured: Up to 15 minutes
Needle tip and shaft imaging visualization
Likert scale: 1-5
Measured: Up to 15 minutes
Requirement of additional needle maneuver due to insufficient local anesthetic distribution
Extra needle redirection to cover neural tissue
Measured: Up to 15 minutes
Total procedure difficulty according to the anesthesiologist
Likert Scale 1-5 (1:very hard 5:very easy)
Measured: Up to 15 minutes
Patient number requiring rescue analgesics
If a ≥ 20% increase above preinduction values in MAP or HR was observed during the perioperative period, additional fentanyl dose (1 μg/kg) was applied intravenously.
Measured: Intraoperative 2-4 hours
Face, Legs Activity, Cry, Consolability (FLACC) scores
It corporates five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild or no pain, 4-7 as moderate, and 8-10 as severe pain.
Measured: Up to 24 hours
Wong Baker FACES scale
The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"
Measured: Up to 24 hours
Motor blockade physical examination
Each nerve scored on 0-2 point scale so that total score ranges from 0 to 8. Total scores of 0 point is defined as absent motor blockade (full movement); 1 point as partial blockade (able to free movement only) or 2 point as complete blockade (unable to move). (Separately for these four nerves; N. Medianus, N. ulnaris, N. radialis and N. musculocutaneous).
Measured: Up to 24 hours
Sensorial blockade physical examination
Each nerve scored on 0-2 point scale with pinprick test so that total score ranges from 0 to 8. Total scores of 0 point is defined as absent sensorial blockade (feels pain), 1 point as partial blockade (feels touch) or 2 point as complete blockade (no sense). (Separately for these four nerves; N. Medianus, N. ulnaris, N. radialis and N. musculocutaneous).
Measured: Up to 24 hours
Time to first pain
Time to first analgesic
Measured: Up to 24 hours
Patient number requiring additional analgesix
Number of patients who require IV morphine (0.03 mg/kg) and paracetamol (15 mg/kg)
Measured: Up to 24 hours
Sleeping duration
Total hours of sleep first day
Measured: Up to 24 hours
Complications/side effects
Possible complications related to costoclavicular block (such as vascular puncture, hematoma, pneumothorax, diaphragma palsy...)
Measured: Up to 24 hours
Family satisfaction
Satisfaction score: 0: very unsatisfied 3: very satisfied
Measured: Up to 24 hours
Surgeon satisfaction
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Jan 2020
- Primary completion25 Dec 2021
- Study completion27 Dec 2021
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 Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RANDOMISED DOUBLE BLINDED INTERVENTIONAL
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
- Investigators
- Meltem Savran Karadeniz, Assoc.Prof., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786756
- Sponsor's protocol ID
- 2019/1556
- Status last verified
- Jan 2022
- First submitted
- 5 Mar 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Songthamwat B, Karmakar MK, Li JW, Samy W, Mok LYH. Ultrasound-Guided Infraclavicular Brachial Plexus Block: Prospective Randomized Comparison of the Lateral Sagittal and Costoclavicular Approach. Reg Anesth Pain Med. 2018 Nov;43(8):825-831. doi: 10.1097/AAP.0000000000000822.
PubMed 29923950
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Lateral and Medial Approaches to Costoclavicular Brachial Plexus Block in Pediatric Patients Undergoing Unilateral Upper Exremity Surgery: A Randomized Controlled Double-Blinded Study
- ClinicalTrials.gov ID
- NCT04786756
- Acronym / sponsor ID
- 2019/1556
- Conditions
- Anesthesia, Local, Postoperative Pain
- Keywords
- Postoperative Analgesia, Upper Extremity Surgery, Costoclavicular Block, Brachial Plexus Block, Ultrasound Guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 27 Dec 2021 (actual)
- First posted
- 8 Mar 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.
In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery. In this study, we aim to compare the different approaches of US guided costoclavicular technique. Lateral approache is more common for the costoclavicular block area. However, more needle maneuvers are needed especially in pediatric patients because of the coracoid process. Medial approach is recommended to overcome this problem. Thus demonstrate the safety of upper extremity blocks, which is an important part of multimodal analgesia, and to determine the most ideal technique in the pediatric patient group who will undergo upper extremity surgery.
During the block application, the US imaging time, the difficulty level of needle imaging, the number of maneuvers required to reach the target image, whether additional maneuvers are required according to the local anesthetic distribution, the success of the block and the duration of the surgery, the total application time of the block and the duration of general anesthesia will be recorded. Mean arterial pressure and heart rate will be recorded at 30-minute intervals during the surgery. Standardized for pediatric patients The FLACC and Wong-Baker pain scores will be followed first 24 hours after surgery. The patient will be examined for motor and sensation, and analgesic doses will be recorded if used. Time to first pain identification, duration of sleep, patient and surgeon satisfaction will be recorded.
Detailed description
Peripheral nerve blocks; It is widely used in daily practice for anesthesia or as a part of multimodal analgesia in most surgical procedures. In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery. In this study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients. In this study, we aim to compare the different approaches of US guided costoclavicular technique. Lateral approache is more common for the costoclavicular block area. However, more needle maneuvers are needed especially in pediatric patients because of the coracoid process. Medial approach is recommended to overcome this problem. Thus demonstrate the safety of upper extremity blocks, which is an important part of multimodal analgesia, and to determine the most ideal technique in the pediatric patient group who will undergo upper extremity surgery.
During the block application, the US imaging time, the difficulty level of needle imaging, the number of maneuvers required to reach the target image, whether additional maneuvers are required according to the local anesthetic distribution, the success of the block and the duration of the surgery, the total application time of the block and the duration of general anesthesia will be recorded. Mean arterial pressure and heart rate will be recorded at 30-minute intervals during the surgery. Standardized for pediatric patients The FLACC and Wong-Baker pain scores will be followed first 24 hours after surgery. The patient will be examined for motor and sensation, and analgesic doses will be recorded if used. Time to first pain identification, duration of sleep, patient and surgeon satisfaction will be recorded.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- RANDOMISED DOUBLE BLINDED INTERVENTIONAL
| Arm | Type | Receives |
|---|---|---|
| Lateral Approach of Costoclavicular Block | Active comparator | Drug: Bupivacaine 0.25% Injectable SolutionUS-guided lateral approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25) |
| Medial Approach of Costoclavicular Block | Active comparator | Drug: Bupivacaine 0.25% Injectable SolutionUS-guided medial approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25) |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Undergoing unilateral upper extremity surgery (distal midhumerus).
- ASA(American Society of Anesthesiology) 1-3
- Receiving family consent from the parents that they accept regional analgesia
Key exclusion criteria (8 listed)
- Parents refusal
- Infection on the local anesthetic application area
- Infection in the central nervous system
- Coagulopathy
- Brain tumors
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 |
|---|---|---|
| Bupivacaine 0.25% Injectable SolutionAlso: Marcaine1 mg/kg Bupivacaine (0.25%) | Drug | Lateral Approach of Costoclavicular Block, Medial Approach of Costoclavicular Block |
Primary outcome
Number of needle maneuvers
Time frame: Up to 15 minutes
Number of needle maneuvers according to local anesthetic distribution
15 secondary outcomes
Ideal USG guided brachial plexus cords visualization/needle pathway planning time
Time frame: Up to 15 minutes
Needle tip and shaft imaging visualization
Time frame: Up to 15 minutes
Requirement of additional needle maneuver due to insufficient local anesthetic distribution
Time frame: Up to 15 minutes
Total procedure difficulty according to the anesthesiologist
Time frame: Up to 15 minutes
Patient number requiring rescue analgesics
Time frame: Intraoperative 2-4 hours
Face, Legs Activity, Cry, Consolability (FLACC) scores
Time frame: Up to 24 hours
Wong Baker FACES scale
Time frame: Up to 24 hours
Motor blockade physical examination
Time frame: Up to 24 hours
Sensorial blockade physical examination
Time frame: Up to 24 hours
Time to first pain
Time frame: Up to 24 hours
Patient number requiring additional analgesix
Time frame: Up to 24 hours
Sleeping duration
Time frame: Up to 24 hours
Complications/side effects
Time frame: Up to 24 hours
Family satisfaction
Time frame: Up to 24 hours
Surgeon satisfaction
Time frame: Up to 24 hours
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 11 Jan 2022.
- Background: PubMed 29923950Songthamwat B, Karmakar MK, Li JW, Samy W, Mok LYH. Ultrasound-Guided Infraclavicular Brachial Plexus Block: Prospective Randomized Comparison of the Lateral Sagittal and Costoclavicular Approach. Reg Anesth Pain Med. 2018 Nov;43(8):825-831. doi: 10.1097/AAP.0000000000000822.
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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.
Meltem Savran Karadeniz, Assoc.Prof. principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine 0.25% Injectable Solution in people with Anesthesia, Local and Postoperative Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
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 8 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 11 Jan 2022. 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 Turkey (Türkiye). 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?
Number of needle maneuvers (time frame: Up to 15 minutes). 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 NCT04786756, 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 11 Jan 2022.