BupivacaineNCT06085417
Comparison of the Effects of Dexamethasone and magnesıum Sulphate Used as Adjuvant in Infraclavicular Nerve Block.
A study testing Bupivacaine + dexamethasone, Bupivacaine + magnesium sulphate and bupivacaine in people with Bupivacaine and Dexamethasone, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective clinical study is to compare the effectiveness of dexamethasone and magnesium sulfate added as adjuvants to bupivacaine in infraclavicular brachial plexus block used under ultrasound guidance for upper extremity surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bupivacaine, Dexamethasone, Magnesıum Sulphate
- What is being tested?
- Bupivacaine + dexamethasone, Bupivacaine + magnesium sulphate and bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2023to 20 Jul 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants providing informed written and verbal consent
- 18-65 years old
- ASA I-II
- Cases undergoing elective upper extremity surger
Who cannot join
- Cases that do not accept regional anesthesia application
- Those who are under 18 years of age and over 65 years of age
- ASA III and above
- Cases in which the operation was started with infraclavicular block and then transferred to general anesthesia.
- Those with liver and kidney dysfunction
- Those with diabetes mellitus
Show all 15Show fewer
- Those with drug allergies
- Patients with acid-base and electrolyte disorders
- Pregnant women
- Emergency cases
- Those with neuropathic disorders
- Those with significant psychiatric and cognitive disorders or substance addiction
- Those with a history of clavicle fracture, pneumonectomy, contralateral hemidiaphragmatic paralysis, pneumothorax, phrenic or recurrent laryngeal nerve palsy.
- Cases with BMI>30 or BMI<18
- Patients in whom regional anesthesia was contraindicated (sepsis, local infection, coagulopathy, heart disease, hypovolemia) were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Dexamethasone and magnesıum Sulphate Used as Adjuvant in Infraclavicular Brachial Plexus Nerve Block.
The aim of this prospective clinical study is to compare the effectiveness of dexamethasone and magnesium sulfate added as adjuvants to bupivacaine in infraclavicular brachial plexus block used under ultrasound guidance for upper extremity surgeries.
Read the detailed description
This study was conducted on 90 patients who underwent upper extremity surgery under infraclavicular brachial plexus block.
90 patients included in the study were randomized into 3 groups of 30 people each by the sealed envelope method.
30 participants were included in Group Bupivacaine, 30 participants were included in Group Bupivacaine + Dexamethasone and 30 participants were included in Group Bupivacaine + Magnesium sulfate.
The study was started as double blind. According to the local anesthetic used, patients were group B (30 patients, 20 cc 0.5% bupivacaine + 5 cc 0.9% NaCl), group B+D (30 patients, 20 cc 0.5% bupivacaine + 4 mg dexamethasone + 4 cc 0.9% NaCl), group They were divided into three groups as B+M (30 patients, 20 cc 0.5% bupivacaine + 150 mg magnesium sulfate + 4 cc 0.9% NaCl).
Complications of the patients, such as sensory block and motor block onset times, peroperative hemodynamic parameters, need for additional analgesia, postoperative block duration, analgesia duration, opioid and NSAID consumption, nausea and vomiting, were recorded
- Conditions
- Bupivacaine, Dexamethasone, Magnesıum Sulphate, Adjuvant
- Being tested
- Bupivacaine + dexamethasone, Bupivacaine + magnesium sulphate, bupivacaine
- Keywords
- Adjuvant, Bupivacaine, Dexamethasone, Infraclavicular brachial plexus nerve block, Magnesıum sulphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine + dexamethasoneDrug
Also called Group B+D
Vital signs were recorded before the block. Peripheral vascular access was established with a 20-gauge catheter and 0.9% NaCl crystalloid solution infusion was started. For sedation, all patients were routinely administered 1mg midazolam intravenously before the procedure. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), SpO₂, sensory and motor block onset times , need for additional sedation, side effects and complications, if any, were recorded. The patients' postoperative sensory block and motor block resolution times, VAS scores at the 0th, 3rd, 6th, 12th and 24th postoperative hours, total opioid and NSAID requirements in the first 24 hours, and analgesia durations were recorded.
During the perioperative period, all patients were monitored for side effects such as nausea, vomiting, tinnitus, metallic taste in the mouth, and drug allergy.
Bupivacaine + magnesium sulphateDrug
Also called Group B+M
Vital signs were recorded before the block. Peripheral vascular access was established with a 20-gauge catheter and 0.9% NaCl crystalloid solution infusion was started. For sedation, all patients were routinely administered 1mg midazolam intravenously before the procedure. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), SpO₂, sensory and motor block onset times , need for additional sedation, side effects and complications, if any, were recorded. The patients' postoperative sensory block and motor block resolution times, VAS scores at the 0th, 3rd, 6th, 12th and 24th postoperative hours, total opioid and NSAID requirements in the first 24 hours, and analgesia durations were recorded.
During the perioperative period, all patients were monitored for side effects such as nausea, vomiting, tinnitus, metallic taste in the mouth, and drug allergy.
bupivacaineDrug
bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group B (bupivacaine) (n= 30) | Sham comparator | For Group B (control group), 100 mg bupivacaine hydrochloride+ isotonic saline (5ml) was administered in a total volume of 25 ml. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, SpO₂, sensory and motor block onset times , need for additional sedation, side effects and complications, if any, were recorded. The patients' postoperative sensory block and motor block resolution times, VAS scores at the 0th, 3rd, 6th, 12th and 24th postoperative hours, total opioid and NSAID requirements in the first 24 hours, and analgesia durations were recorded.
During the perioperative period, all patients were monitored for side effects such as nausea, vomiting, tinnitus, metallic taste in the mouth, and drug allergy. Receives: Drug: bupivacaine |
| Group Group B+D (bupivacaine + dexamethasone group) (n= 30) | Experimental | For Group B+D (bupivacaine + dexamethasone group), 100 mg bupivacaine hydrochloride + 4 mg dexamethasone phosphate+ isotonic saline (4 ml) was administered in a total volume of 25 ml. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, SpO₂, sensory and motor block onset times , need for additional sedation, side effects and complications, if any, were recorded. The patients' postoperative sensory block and motor block resolution times, VAS scores at the 0th, 3rd, 6th, 12th and 24th postoperative hours, total opioid and NSAID requirements in the first 24 hours, and analgesia durations were recorded. During the perioperative period, all patients were monitored for side effects such as nausea, vomiting, tinnitus, metallic taste in the mouth, and drug allergy. Receives: Drug: Bupivacaine + dexamethasone |
| Group B+M (bupivacaine + magnesium group) (n= 30) | Active comparator | For Group B+M (bupivacaine + magnesium group), 100 mg bupivacaine hydrochloride (20ml 0.5% marcaine aspen, turkey) + 150 mg magnesium sulfate (1ml 15% magnesium sulfate, onfarma, turkey) + isotonic saline (4 ml) was administered in a total volume of 25 ml. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, SpO₂, sensory and motor block onset times , need for additional sedation, side effects and complications, if any, were recorded. The patients' postoperative sensory block and motor block resolution times, VAS scores at the 0th, 3rd, 6th, 12th and 24th postoperative hours, total opioid and NSAID requirements in the first 24 hours, and analgesia durations were recorded.
During the perioperative period, all patients were monitored for side effects such as nausea, vomiting, tinnitus, metallic taste in the mouth, and drug allergy. Receives: Drug: Bupivacaine + magnesium sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor block onset time
Motor block examination was performed with the modified Bromage scale. In the motor block examination, thumb orientation was examined for the median nerve, thumb abduction for the radial nerve, thumb adduction for the ulnar nerve, and elbow flexion for the musculocutaneous nerve. Patients with a modified Bromage scale ≤ 2 on the side where the block was applied were considered to have a successful block and the patient's surgery was initiated.
Measured: 24 hours
Motor Block Duration
Motor block durations were determined according to the Bromage scales at the 1st, 3rd, 6th, 12th and 24th postoperative hours.
Measured: 24 hours
Sensory block onset time
Pinprick sensory test was used in the sensory examination of the patients. Sensory examination was performed using a pinprick test on the first 3 fingers and the dorsal side of the wrist for the radial nerve, the medial side of the 5th finger for the ulnar nerve, the first 3 fingers and the volar side of the wrist for the median nerve, and the lateral region of the forearm for the musculocutaneous nerve.Pinprick sensory test ≤ 1 on the side where the block was applied were considered to have a successful block and the patient's surgery was initiated.
Measured: 24 hours
Sensory block duration
Sensory block durations were determined according to the Pinprick sensory test at the 1st, 3rd, 6th, 12th and 24th postoperative hours.
Measured: 24 hours
VAS score
VAS scores at the 1st, 3rd, 6th, 12th and 24th postoperative hours were evaluated. Dexketoprofen trometamol 50 mg was given intravenously to patients with a postoperative VAS Score of 4 and above. If the VAS Score was 6 or above even though NSAIDs were administered, the patients were given the opioid analgesic tramadol hydrochloride 1 mg/kg intravenously.
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 posted17 Oct 2023
- Study start2 Jan 2023
- Primary completion2 Jan 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BupivacaineStudies of the same condition, open and under way.
- 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
- Sequential
- Model description
- The required asepsis in the area where the block would be applied was provided with 10% poviodine iodine and covered with a sterile drape. The USG probe was placed in the sagittal plane 1 cm below the intersection point between the coracoid process and the clavicle, and after visualizing the lateral, posterior and medial cords around the axillary artery, a peripheral nerve block needle was directed towards the 8 o'clock position relative to the axillary artery, in the same plane as the USG probe. When the expected distal motor response was obtained, the current of the peripheral nerve stimulator was reduced to 0.3 mA to avoid intraneural injection. If the motor response disappeared, local anesthetic was injected slowly. Sensory and motor block onset times, saturation, systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate peak values at the 0th, 15th, 30th and 60th minutes after the block were recorded.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacı Yusuf Güneş, MD, Yuzuncu Yil University
- Investigators
- Haci Y GUNES, Assist.prof, Principal investigator, Van Yüzüncü Yıl University Van, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085417
- Sponsor's protocol ID
- 03.03.2022/03
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical analysis plan will be share for other resarchers.
Publications
Mirza F, Brown AR. Ultrasound-guided regional anesthesia for procedures of the upper extremity. Anesthesiol Res Pract. 2011;2011:579824. doi: 10.1155/2011/579824. Epub 2011 May 30.
PubMed 21716734O'Donnell BD, Ryan H, O'Sullivan O, Iohom G. Ultrasound-guided axillary brachial plexus block with 20 milliliters local anesthetic mixture versus general anesthesia for upper limb trauma surgery: an observer-blinded, prospective, randomized, controlled trial. Anesth Analg. 2009 Jul;109(1):279-83. doi: 10.1213/ane.0b013e3181a3e721.
PubMed 19535722Klaastad O, Sauter AR, Dodgson MS. Brachial plexus block with or without ultrasound guidance. Curr Opin Anaesthesiol. 2009 Oct;22(5):655-60. doi: 10.1097/ACO.0b013e32832eb7d3.
PubMed 19550303
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Dexamethasone and magnesıum Sulphate Used as Adjuvant in Infraclavicular Brachial Plexus Nerve Block.
- ClinicalTrials.gov ID
- NCT06085417
- Acronym / sponsor ID
- 03.03.2022/03
- Conditions
- Bupivacaine, Dexamethasone, Magnesıum Sulphate, Adjuvant
- Keywords
- Adjuvant, Bupivacaine, Dexamethasone, Infraclavicular brachial plexus nerve block, Magnesıum sulphate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 2 Jan 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 17 Oct 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.
The aim of this prospective clinical study is to compare the effectiveness of dexamethasone and magnesium sulfate added as adjuvants to bupivacaine in infraclavicular brachial plexus block used under ultrasound guidance for upper extremity surgeries.
Detailed description
This study was conducted on 90 patients who underwent upper extremity surgery under infraclavicular brachial plexus block.
90 patients included in the study were randomized into 3 groups of 30 people each by the sealed envelope method.
30 participants were included in Group Bupivacaine, 30 participants were included in Group Bupivacaine + Dexamethasone and 30 participants were included in Group Bupivacaine + Magnesium sulfate.
The study was started as double blind. According to the local anesthetic used, patients were group B (30 patients, 20 cc 0.5% bupivacaine + 5 cc 0.9% NaCl), group B+D (30 patients, 20 cc 0.5% bupivacaine + 4 mg dexamethasone + 4 cc 0.9% NaCl), group They were divided into three groups as B+M (30 patients, 20 cc 0.5% bupivacaine + 150 mg magnesium sulfate + 4 cc 0.9% NaCl).
Complications of the patients, such as sensory block and motor block onset times, peroperative hemodynamic parameters, need for additional analgesia, postoperative block duration, analgesia duration, opioid and NSAID consumption, nausea and vomiting, were recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The required asepsis in the area where the block would be applied was provided with 10% poviodine iodine and covered with a sterile drape. The USG probe was placed in the sagittal plane 1 cm below the intersection point between the coracoid process and the clavicle, and after visualizing the lateral, posterior and medial cords around the axillary artery, a peripheral nerve block needle was directed towards the 8 o'clock position relative to the axillary artery, in the same plane as the USG probe. When the expected distal motor response was obtained, the current of the peripheral nerve stimulator was reduced to 0.3 mA to avoid intraneural injection. If the motor response disappeared, local anesthetic was injected slowly. Sensory and motor block onset times, saturation, systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate peak values at the 0th, 15th, 30th and 60th minutes after the block were recorded.
| Arm | Type | Receives |
|---|---|---|
| Group B (bupivacaine) (n= 30) | Sham comparator | Drug: bupivacaineFor Group B (control group), 100 mg bupivacaine hydrochloride+ isotonic saline (5ml) was administered in a total volume of 25 ml. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, SpO₂, sensory and motor block onset times , need for additional sedation, side effects and complications, if any, were recorded. The patients' postoperative sensory block and motor block resolution times, VAS scores at the 0th, 3rd, 6th, 12th and 24th postoperative hours, total opioid and NSAID requirements in the first 24 hours, and analgesia durations were recorded. During the perioperative period, all patients were monitored for side effects such as nausea, vomiting, tinnitus, metallic taste in the mouth, and drug allergy. |
| Group Group B+D (bupivacaine + dexamethasone group) (n= 30) | Experimental | Drug: Bupivacaine + dexamethasoneFor Group B+D (bupivacaine + dexamethasone group), 100 mg bupivacaine hydrochloride + 4 mg dexamethasone phosphate+ isotonic saline (4 ml) was administered in a total volume of 25 ml. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, SpO₂, sensory and motor block onset times , need for additional sedation, side effects and complications, if any, were recorded. The patients' postoperative sensory block and motor block resolution times, VAS scores at the 0th, 3rd, 6th, 12th and 24th postoperative hours, total opioid and NSAID requirements in the first 24 hours, and analgesia durations were recorded. During the perioperative period, all patients were monitored for side effects such as nausea, vomiting, tinnitus, metallic taste in the mouth, and drug allergy. |
| Group B+M (bupivacaine + magnesium group) (n= 30) | Active comparator | Drug: Bupivacaine + magnesium sulphateFor Group B+M (bupivacaine + magnesium group), 100 mg bupivacaine hydrochloride (20ml 0.5% marcaine aspen, turkey) + 150 mg magnesium sulfate (1ml 15% magnesium sulfate, onfarma, turkey) + isotonic saline (4 ml) was administered in a total volume of 25 ml. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, SpO₂, sensory and motor block onset times , need for additional sedation, side effects and complications, if any, were recorded. The patients' postoperative sensory block and motor block resolution times, VAS scores at the 0th, 3rd, 6th, 12th and 24th postoperative hours, total opioid and NSAID requirements in the first 24 hours, and analgesia durations were recorded. During the perioperative period, all patients were monitored for side effects such as nausea, vomiting, tinnitus, metallic taste in the mouth, and drug allergy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants providing informed written and verbal consent
- 18-65 years old
- ASA I-II
- Cases undergoing elective upper extremity surger
Key exclusion criteria (15 listed)
- Cases that do not accept regional anesthesia application
- Those who are under 18 years of age and over 65 years of age
- ASA III and above
- Cases in which the operation was started with infraclavicular block and then transferred to general anesthesia.
- Those with liver and kidney dysfunction
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 + dexamethasoneAlso: Group B+DVital signs were recorded before the block. Peripheral vascular access was established with a 20-gauge catheter and 0.9% NaCl crystalloid solution infusion was started. For sedation, all patients were routinely administered 1mg midazolam intravenously before the procedure. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), SpO₂, sensory and motor block onset times , need for additional sedation, side effects and complications, if any, were recorded. The patients' postoperative sensory block and motor block resolution times, VAS scores at the 0th, 3rd, 6th, 12th and 24th postoperative hours, total opioid and NSAID requirements in the first 24 hours, and analgesia durations were recorded. During the perioperative period, all patients were monitored for side effects such as nausea, vomiting, tinnitus, metallic taste in the mouth, and drug allergy. | Drug | Group Group B+D (bupivacaine + dexamethasone group) (n= 30) |
| Bupivacaine + magnesium sulphateAlso: Group B+MVital signs were recorded before the block. Peripheral vascular access was established with a 20-gauge catheter and 0.9% NaCl crystalloid solution infusion was started. For sedation, all patients were routinely administered 1mg midazolam intravenously before the procedure. Patients' ASA score, demographic data (age, height, weight), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), SpO₂, sensory and motor block onset times , need for additional sedation, side effects and complications, if any, were recorded. The patients' postoperative sensory block and motor block resolution times, VAS scores at the 0th, 3rd, 6th, 12th and 24th postoperative hours, total opioid and NSAID requirements in the first 24 hours, and analgesia durations were recorded. During the perioperative period, all patients were monitored for side effects such as nausea, vomiting, tinnitus, metallic taste in the mouth, and drug allergy. | Drug | Group B+M (bupivacaine + magnesium group) (n= 30) |
| bupivacainebupivacaine | Drug | Group B (bupivacaine) (n= 30) |
Primary outcome
Motor block onset time
Time frame: 24 hours
Motor block examination was performed with the modified Bromage scale. In the motor block examination, thumb orientation was examined for the median nerve, thumb abduction for the radial nerve, thumb adduction for the ulnar nerve, and elbow flexion for the musculocutaneous nerve. Patients with a modified Bromage scale ≤ 2 on the side where the block was applied were considered to have a successful block and the patient's surgery was initiated.
Motor Block Duration
Time frame: 24 hours
Motor block durations were determined according to the Bromage scales at the 1st, 3rd, 6th, 12th and 24th postoperative hours.
Sensory block onset time
Time frame: 24 hours
Pinprick sensory test was used in the sensory examination of the patients. Sensory examination was performed using a pinprick test on the first 3 fingers and the dorsal side of the wrist for the radial nerve, the medial side of the 5th finger for the ulnar nerve, the first 3 fingers and the volar side of the wrist for the median nerve, and the lateral region of the forearm for the musculocutaneous nerve.Pinprick sensory test ≤ 1 on the side where the block was applied were considered to have a successful block and the patient's surgery was initiated.
Sensory block duration
Time frame: 24 hours
Sensory block durations were determined according to the Pinprick sensory test at the 1st, 3rd, 6th, 12th and 24th postoperative hours.
VAS score
Time frame: 24 hours
VAS scores at the 1st, 3rd, 6th, 12th and 24th postoperative hours were evaluated. Dexketoprofen trometamol 50 mg was given intravenously to patients with a postoperative VAS Score of 4 and above. If the VAS Score was 6 or above even though NSAIDs were administered, the patients were given the opioid analgesic tramadol hydrochloride 1 mg/kg intravenously.
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 17 Oct 2023.
- Background: PubMed 21716734Mirza F, Brown AR. Ultrasound-guided regional anesthesia for procedures of the upper extremity. Anesthesiol Res Pract. 2011;2011:579824. doi: 10.1155/2011/579824. Epub 2011 May 30.
- Background: PubMed 19535722O'Donnell BD, Ryan H, O'Sullivan O, Iohom G. Ultrasound-guided axillary brachial plexus block with 20 milliliters local anesthetic mixture versus general anesthesia for upper limb trauma surgery: an observer-blinded, prospective, randomized, controlled trial. Anesth Analg. 2009 Jul;109(1):279-83. doi: 10.1213/ane.0b013e3181a3e721.
- Background: PubMed 19550303Klaastad O, Sauter AR, Dodgson MS. Brachial plexus block with or without ultrasound guidance. Curr Opin Anaesthesiol. 2009 Oct;22(5):655-60. doi: 10.1097/ACO.0b013e32832eb7d3.
- Individual participant dataSharing planned: Yes. Study protocol and statistical analysis plan will be share for other resarchers.
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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.
Haci Y GUNES, Assist.prof principal investigator
Van Yüzüncü Yıl University Van, Turkey
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 + dexamethasone, Bupivacaine + magnesium sulphate and bupivacaine in people with Bupivacaine and Dexamethasone, run by Yuzuncu Yil 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 4 inclusion and 15 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 17 Oct 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 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. Some participants in this study may receive a placebo. 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?
Motor block onset time (time frame: 24 hours). The study lists 5 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 NCT06085417, which also lists 3 linked publications.
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 17 Oct 2023.