Upper Limb InjuryNCT06180941
Adjuvants for Bupivacaine in Brachial Plexus Block in Pediatrics
A study testing magnesium sulfate. and clonidine. in people with Upper Limb Injury, run by Assiut University.
Trial summary
Among paediatrics aging 3:12 who are going to have upper limb surgery,does adding clonidine to bupivacaine improve brachial plexus block outcome in comparison with magnesium sulfate with bupivacaine? Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Upper Limb Injury
- What is being tested?
- magnesium sulfate. and clonidine.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Jul 2024
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anaesthesiologists Classes I and II patients.
- within the age group of 3-12 years.
- requiring unilateral upper limb surgery at or below the elbow.
Who cannot join
- The patients that have contraindications to regional anaesthetics, previous nerve injuries, history of allergy to study drugs, history of bleeding disorders.
- children with any mental disability which will confound pain assessment or inability to understand the pain scale used in the study.
- patients on anticoagulants.
- patients with any major systemic illness will be excluded from the study.
About this study
Official title: The Effect of Magnesium Sulfate in Comparison to Clonidine as Adjuvants to Bupivacaine 0.25% in Supraclavicular Brachial Plexus Block in Pediatric Upper Limb Surgeries. Prospective, Randomized, Double-blind Study
Among paediatrics aging 3:12 who are going to have upper limb surgery,does adding clonidine to bupivacaine improve brachial plexus block outcome in comparison with magnesium sulfate with bupivacaine?
Read the detailed description
In upper extremity surgery, brachial plexus blocks are often preferred due to their advantages, such as long postoperative analgesic efficacy and shortening the length of hospital stay. This application reduces the use of opioids for postoperative analgesia and provides protection from their side effects. However, procedure failure, nerve injury and intravascular injection are the most common complications in the past years. In recent years, performing ultrasound-guided blocks has increased the success of the procedure and decreased the complication rate. Low number of studies, knowledge and experience in paediatric patients led to worries that complications will be more common and caused less use of regional techniques. However, good visualization of the anatomy in ultrasound-guided blocks and successful results in adult patients brought up the application of ultrasound-guided brachial plexus blocks in children.
Effective postoperative analgesia improves patient's outcome in terms of early ambulation, decreased complications, and reduced incidence of postoperative chronic pain. Regional anaesthetics is a safe and effective method for upper limb surgeries. This method can prolong analgesia and reduce postoperative pain. Nowadays, peripheral nerve block has found an important role in anaesthesiology. Safety and high success rate have made it a common technique in outpatient and inpatient anaesthetics. Upper limb surgeries are mostly performed under peripheral nerve blocks such as brachial plexus block. Brachial plexus may be blocked in the level above the clavicle as interscalene and supraclavicular blocks or below the clavicle as infraclavicular and axillary blocks. Supraclavicular brachial plexus block is used for surgeries of the upper limb below the arm, from elbow to hand. Brachial plexus is blocked in the level between trunks and divisions. In this level, a small volume of local anaesthetic is needed for reliable block. The guide of ultrasound allows the anaesthesiologist to see the subclavian artery as a bold marker and neural structures around it above the 1st rib Regional anaesthetics may be one of the best solutions for intraoperative and postoperative paediatric pain management; Supraclavicular brachial plexus block is considered as one of the most effective anaesthetic methods for upper extremity surgeries. Its major drawback, especially in children, is the risk of pneumothorax, vascular puncture, and failure of the procedure due to inaccurate placement of the needle. Ultrasound-guided needle placement may reduce the risk of complications and increase the accuracy of block, particularly in paediatric patients. According to the surgeon's preference and due to the need for a tourniquet at the proximal part of the humerus in all surgeries regardless of the type of surgery, we considered supraclavicular block to be more suitable than more distal ones. This block can be done with only one injection around the plexus and provides sufficient anaesthetics at the tourniquet site as well.
Lignocaine and bupivacaine are the commonly used local anaesthetics in Brachial plexus blocks. Lidocaine is an aminoamide, moderate acting local anaesthetic that blocks the peripheral afferents acting on voltage-dependent sodium channels, Bupivacaine is a potent local anaesthetic with unique characteristics from the amide group of local anaesthetics, which was first discovered in 1957 and widely used for prolonged local and regional anaesthetics.
To increase the duration of local anaesthetic effect in the supraclavicular block,Local anaesthetics provide good anaesthetics in regional blocks, but have shorter duration of postoperative analgesia. Thereby, various adjuncts like opioids, clonidine, neostigmine, dexamethasone, alpha-2 agonists, dexmedetomidine, ketorolac, ketamine, and low-level laser therapy, have been used in regional blocks to achieve desirable analgesia.
In the meantime, epinephrine is mostly used. Although epinephrine reduces the absorption of local anaesthetics, reduces their toxicity, and prolongs anaesthetic duration, it can cause hypertension and tachycardia. Therefore, its usage is limited when the patients have cardiovascular disease or hyperthyroidism Magnesium sulphate is an N-methyl D-aspartate (NMDA) receptor antagonist in the central nervous system (CNS) and peripheral nervous system (PNS). The NMDA receptor complex contains binding sites for antagonists such as magnesium. Magnesium is used as an adjuvant in peripheral nerve block. Anti-nociceptive effects of magnesium are due to the regulation of calcium influx into the cell and antagonism of the NMDA receptors. Many clinical studies have demonstrated that magnesium used during general anaesthetics reduced anaesthetic requirement and postoperative rescue analgesic. Magnesium has been commonly used as an antihypertensive agent. Magnesium may prevent postoperative shivering. More recently, it has been shown that magnesium sulfate decreased the effects of aminoamide local anaesthetics on rat sciatic nerves in vivo.
Recently, alpha-2 receptor-stimulating drugs due to excellent sedative effects, analgesia, and anaesthetics with hemodynamic stability have been considered These pharmacologic properties have been employed clinically to achieve the desired effects in regional anaesthetics.
Clonidine, an a2 adrenergic agonist has sedative, analgesic, perioperative sympatholytic with cardiovascular stabilizing effects and has been tried in combination with local anaesthetic drugs to enhance regional anaesthetics.
- Conditions
- Upper Limb Injury
- Being tested
- magnesium sulfate., clonidine.
- Medical subject headings
- Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium sulfate.Drug
magnesium sulfate as adjuvant to bupivacaine in supraclavicular brachial plexus block in pediatrics.
clonidine.Drug
clonidine as adjuvant to bupivacaine in supraclavicular brachial plexus block in pediatrics.
| Study group | Role | What they receive |
|---|---|---|
| magnesium sulfate as adjuvant to bupivacaine. | Active comparator | Group M: 2mg/kg Magnesium sulfate will be added to 0.5 mL.kg-1 of 0.25% bupivacaine (max 2 mg/kg) with a total volume of 0.5 ml/kg, (according to the spread of local anesthetic surrounding the brachial plexus) Receives: Drug: magnesium sulfate. |
| clonidine as adjuvant to bupivacaine. | Active comparator | Group C: 0.75 μg.kg-1 of clonidine will be added to 0.5 mL.kg-1 of 0.25% bupivacaine (max 2 mg/kg) with a total volume of 0.5 ml/kg, (according to the spread of local anesthetic surrounding the brachial plexus) Receives: Drug: clonidine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia.
The time(in hours) to first rescue analgesia which is defined as the time since the block performance till the first administration of any rescue analgesia in the postoperative period.
Measured: 24 hours
Secondary outcomes (1)
Postoperative analgesia.
Wong-Baker faces pain rating scale (WBFPS) will be used for pain assessment in both the groups at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 12 h, and 24 h. The number of children with WBFPS >6 at any time point will be recorded for both groups.
Wong-Baker faces pain rating scale (WBFPS) presents 6 faces with increasing degree of pain from left to right. Each face is attributed scale from 0 to 10 indicated on scale. Children will be asked to choose the face that best describes his or her own pain.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb InjuryStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Abdulbassit mohammed abdou, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180941
- Sponsor's protocol ID
- brachial plexus block.
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Magnesium Sulfate in Comparison to Clonidine as Adjuvants to Bupivacaine 0.25% in Supraclavicular Brachial Plexus Block in Pediatric Upper Limb Surgeries. Prospective, Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT06180941
- Acronym / sponsor ID
- brachial plexus block.
- Conditions
- Upper Limb Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 26 Dec 2023 (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.
Among paediatrics aging 3:12 who are going to have upper limb surgery,does adding clonidine to bupivacaine improve brachial plexus block outcome in comparison with magnesium sulfate with bupivacaine?
Detailed description
In upper extremity surgery, brachial plexus blocks are often preferred due to their advantages, such as long postoperative analgesic efficacy and shortening the length of hospital stay. This application reduces the use of opioids for postoperative analgesia and provides protection from their side effects. However, procedure failure, nerve injury and intravascular injection are the most common complications in the past years. In recent years, performing ultrasound-guided blocks has increased the success of the procedure and decreased the complication rate. Low number of studies, knowledge and experience in paediatric patients led to worries that complications will be more common and caused less use of regional techniques. However, good visualization of the anatomy in ultrasound-guided blocks and successful results in adult patients brought up the application of ultrasound-guided brachial plexus blocks in children.
Effective postoperative analgesia improves patient's outcome in terms of early ambulation, decreased complications, and reduced incidence of postoperative chronic pain. Regional anaesthetics is a safe and effective method for upper limb surgeries. This method can prolong analgesia and reduce postoperative pain. Nowadays, peripheral nerve block has found an important role in anaesthesiology. Safety and high success rate have made it a common technique in outpatient and inpatient anaesthetics. Upper limb surgeries are mostly performed under peripheral nerve blocks such as brachial plexus block. Brachial plexus may be blocked in the level above the clavicle as interscalene and supraclavicular blocks or below the clavicle as infraclavicular and axillary blocks. Supraclavicular brachial plexus block is used for surgeries of the upper limb below the arm, from elbow to hand. Brachial plexus is blocked in the level between trunks and divisions. In this level, a small volume of local anaesthetic is needed for reliable block. The guide of ultrasound allows the anaesthesiologist to see the subclavian artery as a bold marker and neural structures around it above the 1st rib Regional anaesthetics may be one of the best solutions for intraoperative and postoperative paediatric pain management; Supraclavicular brachial plexus block is considered as one of the most effective anaesthetic methods for upper extremity surgeries. Its major drawback, especially in children, is the risk of pneumothorax, vascular puncture, and failure of the procedure due to inaccurate placement of the needle. Ultrasound-guided needle placement may reduce the risk of complications and increase the accuracy of block, particularly in paediatric patients. According to the surgeon's preference and due to the need for a tourniquet at the proximal part of the humerus in all surgeries regardless of the type of surgery, we considered supraclavicular block to be more suitable than more distal ones. This block can be done with only one injection around the plexus and provides sufficient anaesthetics at the tourniquet site as well.
Lignocaine and bupivacaine are the commonly used local anaesthetics in Brachial plexus blocks. Lidocaine is an aminoamide, moderate acting local anaesthetic that blocks the peripheral afferents acting on voltage-dependent sodium channels, Bupivacaine is a potent local anaesthetic with unique characteristics from the amide group of local anaesthetics, which was first discovered in 1957 and widely used for prolonged local and regional anaesthetics.
To increase the duration of local anaesthetic effect in the supraclavicular block,Local anaesthetics provide good anaesthetics in regional blocks, but have shorter duration of postoperative analgesia. Thereby, various adjuncts like opioids, clonidine, neostigmine, dexamethasone, alpha-2 agonists, dexmedetomidine, ketorolac, ketamine, and low-level laser therapy, have been used in regional blocks to achieve desirable analgesia.
In the meantime, epinephrine is mostly used. Although epinephrine reduces the absorption of local anaesthetics, reduces their toxicity, and prolongs anaesthetic duration, it can cause hypertension and tachycardia. Therefore, its usage is limited when the patients have cardiovascular disease or hyperthyroidism Magnesium sulphate is an N-methyl D-aspartate (NMDA) receptor antagonist in the central nervous system (CNS) and peripheral nervous system (PNS). The NMDA receptor complex contains binding sites for antagonists such as magnesium. Magnesium is used as an adjuvant in peripheral nerve block. Anti-nociceptive effects of magnesium are due to the regulation of calcium influx into the cell and antagonism of the NMDA receptors. Many clinical studies have demonstrated that magnesium used during general anaesthetics reduced anaesthetic requirement and postoperative rescue analgesic. Magnesium has been commonly used as an antihypertensive agent. Magnesium may prevent postoperative shivering. More recently, it has been shown that magnesium sulfate decreased the effects of aminoamide local anaesthetics on rat sciatic nerves in vivo.
Recently, alpha-2 receptor-stimulating drugs due to excellent sedative effects, analgesia, and anaesthetics with hemodynamic stability have been considered These pharmacologic properties have been employed clinically to achieve the desired effects in regional anaesthetics.
Clonidine, an a2 adrenergic agonist has sedative, analgesic, perioperative sympatholytic with cardiovascular stabilizing effects and has been tried in combination with local anaesthetic drugs to enhance regional anaesthetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnesium sulfate as adjuvant to bupivacaine. | Active comparator | Drug: magnesium sulfate.Group M: 2mg/kg Magnesium sulfate will be added to 0.5 mL.kg-1 of 0.25% bupivacaine (max 2 mg/kg) with a total volume of 0.5 ml/kg, (according to the spread of local anesthetic surrounding the brachial plexus) |
| clonidine as adjuvant to bupivacaine. | Active comparator | Drug: clonidine.Group C: 0.75 μg.kg-1 of clonidine will be added to 0.5 mL.kg-1 of 0.25% bupivacaine (max 2 mg/kg) with a total volume of 0.5 ml/kg, (according to the spread of local anesthetic surrounding the brachial plexus) |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anaesthesiologists Classes I and II patients.
- within the age group of 3-12 years.
- requiring unilateral upper limb surgery at or below the elbow.
Key exclusion criteria (4 listed)
- The patients that have contraindications to regional anaesthetics, previous nerve injuries, history of allergy to study drugs, history of bleeding disorders.
- children with any mental disability which will confound pain assessment or inability to understand the pain scale used in the study.
- patients on anticoagulants.
- patients with any major systemic illness will be excluded from the study.
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 |
|---|---|---|
| magnesium sulfate.magnesium sulfate as adjuvant to bupivacaine in supraclavicular brachial plexus block in pediatrics. | Drug | magnesium sulfate as adjuvant to bupivacaine. |
| clonidine.clonidine as adjuvant to bupivacaine in supraclavicular brachial plexus block in pediatrics. | Drug | clonidine as adjuvant to bupivacaine. |
Primary outcome
Time to first rescue analgesia.
Time frame: 24 hours
The time(in hours) to first rescue analgesia which is defined as the time since the block performance till the first administration of any rescue analgesia in the postoperative period.
1 secondary outcome
Postoperative analgesia.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing magnesium sulfate. and clonidine. in people with Upper Limb Injury, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Time to first rescue analgesia. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2023.