Supraclavicular Brachial Plexus BlockNCT04508894
Ketamine Versus Dexmedetomidine in Supraclavicular Brachial Plexus Block
A study testing Supraclavicular Brachial Plexus Block with bupivacaine, Supraclavicular Brachial Plexus Block with Ketamine and Supraclavicular Brachial Plexus Block with Dexmedetomidine in people with Supraclavicular Brachial Plexus Block, run by Minia University at 1 site in Egypt.
Trial summary
Intervention model description: The patients were randomly classified into three groups using computer-generated table numbers each contain (25) patients. Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine, Dexmedetomidine group (group D): 20 ml 0.5% bupivacaine and 20… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Supraclavicular Brachial Plexus Block
- What is being tested?
- Supraclavicular Brachial Plexus Block with bupivacaine, Supraclavicular Brachial Plexus Block with Ketamine and Supraclavicular Brachial Plexus Block with Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Apr 2019to 30 Dec 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Physical Status I or II
- patients undergoing elective and emergency forearm and hand surgeries
Who cannot join
- Patient with bleeding disorders
- Damage or disease of the brachial plexus
- Uncontrolled diabetes mellitus
- Patients with neuromuscular diseases
- Patients with a local skin infection at the site of injection
- Patients with known hypersensitivity to studied drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketamine Versus Dexmedetomidine as an Adjuvant in Ultrasound-guided Supraclavicular Brachial Plexus Block
Intervention model description: The patients were randomly classified into three groups using computer-generated table numbers each contain (25) patients.
Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine, Dexmedetomidine group (group D): 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine Control group (group C): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline. Masking: double-blind (participant and investigator) Masking Description: The investigator's study is a prospective, randomized, double-blind
Read the detailed description
This randomized, prospective, double-blind study was carried out on 75 ASA Physical Status I-II adults aged 18-75 years old scheduled to undergo elective and emergency forearm and hand surgeries under ultrasound-guided supraclavicular brachial plexus block. After obtaining the local ethics committee of El-Minia university hospital approval and written informed consent was taken of the patient, this study was conducted from April 2019 to February 2020 in El-Minia university hospital. The investigators excluded any patient with bleeding disorders, damage or disease of the brachial plexus, uncontrolled diabetes mellitus, and patients with neuromuscular diseases, Patients with a local skin infection at the site of injection or patients with known hypersensitivity to studied drugs.
Preoperative assessment and preparation: A careful assessment of medical history, general examination including chest, heart, abdomen, site of injection and other systems were carried out. Routine investigations were done as complete blood picture, ECG (electrocardiogram) renal and liver functions. An explanation of the visual analog scale was done to each patient.
Preparation of the studied medications: The patients were randomly classified into three groups using computer-generated table numbers each contains (25) patients. Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine, Dexmedetomidine group (group D) 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine (precedex® Hospira,Inc., Lake Forest USA).
Control group (group C) 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline. All medications were prepared in similar sterile coated bottles by the supervisor who didn't include in the anesthetic or operative team, 75 bottles numbered from 1 to 75 were prepared. After completion of the study, the key was opened by the supervisor Block technique: On patient's arrival to the operating room, a 20 G intravenous cannula was inserted in a peripheral vein of unaffected limb and standard monitoring commenced as noninvasive blood pressure (NIBP), (ECG), and Oxygen saturation (Spo2) (UltraviewSL2700, Spacelaps, USA), all equipment and drugs for general anesthesia and resuscitation were prepared, the ultrasound device (Sonosite, Nanomax, USA ) lubricating gel, 21guge 50 mm length, short bevel, insulated stimulating needle (Laboratoires pharmaceutiques, Vygon, France). Patient lie supine with the head turned to the other side and ipsilateral arm adducted gently with a flexed elbow. Under the complete aseptic condition, the identified area and the ultrasound probe was prepared with anti-septic (Povidone-Iodine 10%) solution and the skin infiltrated with 1-2 ml of lidocaine 2% solution subcutaneously, the brachial plexus was visualized by placing the transducer in the sagittal plane in the supraclavicular fossa behind the middle-third of the clavicle. Two distinct appearances of the supraclavicular brachial plexus was seen, it either appeared as a grape-like cluster of 5 to 6 hypoechoic circles, located lateral and superior to the subclavian artery between the anterior and middle scalene muscles at the lower cervical region or as 3 hypoechoic circles with hyperechoic outer rings, the predetermined volume of 40 mL of the study drug solution was administered around the brachial plexus after negative aspiration to avoid accidental intravascular injection, expansion of the brachial plexus sheath was considered as an indication of correct needle placement, multiple injections were used to deposit the total amount of the study drugs, skin massage for about 3 minutes was done to facilitate drug distribution.
Parameters assessed:
- Hemodynamic data: The hemodynamic variables as HR, MAP and Spo2 were assessed. The parameters were recorded preoperatively just before the block as a baseline value, at 5,10,20,30,60, 90 minutes during the operative time and at 1,2,4,6,9 and 12 hours after the end of the operation.
- Sensory block was assessed by pinprick test using a 3-point scale [16] Grade 0 = normal sensation, Grade 1 = loss of sensation of pinprick (analgesia), and Grade 2 = loss of sensation of touch (anesthesia).
- Motor block was determined by thumb abduction (radial nerve), thumb adduction (ulnar nerve), thumb opposition (median nerve), and flexion of elbow (musculocutaneous nerve) according to the modified Bromage 3 point scale: Grade 0: Normal motor function with full flexion and extension of elbow, wrist, and fingers. Grade 1: Decreased motor strength with the ability to move the fingers only. Grade 2: Complete motor block with an inability to move the fingers [16].
- Onset time for sensory and motor block: the time interval between the end of local anesthetic administration and complete sensory and motor block by min.
- Sensory block duration: the time interval between the complete sensory block and complete resolution of anesthesia on all the nerves (score 0(
- Motor block duration: the time interval from complete motor block to complete recovery of motor function of hand and forearm (grade 0) by hours.
- Visual analog scale (VAS): postoperative, the patients were familiarized with a 10-point visual analog scale (VAS) ranged from 0 = no pain, up to 10 = the worse imaginable pain. VAS was measured at 1, 2, 3, 6, 9, 12 hours. When it equals or >4 the investigators give IM diclofenac sodium (75 mg amp) (Voltaren, Novartis Pharmaceuticals Corporation, Switzerland).
- Time of first analgesic request: The time passed from supraclavicular brachial plexus block to the patient's first request for analgesic medication by hours
- Total analgesic requirements in 24 hours) diclofenac consumption)
- Sedation score: was assessed according to the modified Ramsay Sedation Scale 1987(RSS) from 1-6 as follows: 1 = anxious, agitated, restless; 2 = cooperative, oriented, tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or loud noise; 5 = sluggish response to light glabellar tap or loud noise; 6 = no response [17].
- Adverse effects: any adverse effects such as hypotension (i.e. 20% decrease relative to baseline), bradycardia (HR <60 beats/min), nausea, vomiting, hypoxemia (SpO2 <90%), local hematoma, hemothorax, pneumothorax, recurrent laryngeal nerve block, intravascular injection, Horner's syndrome and signs of local anesthetic toxicity were recorded during the operation and for 12 hours postoperative.
- Conditions
- Supraclavicular Brachial Plexus Block
- Being tested
- Supraclavicular Brachial Plexus Block with bupivacaine, Supraclavicular Brachial Plexus Block with Ketamine, Supraclavicular Brachial Plexus Block with Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraclavicular Brachial Plexus Block with bupivacaineDrug
Also called C group
drug: 20 ml 0.5%bupivacaine plus 20 ml 0.9% normal saline is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.
Device: ultrasound-guided supraclavicular Brachial Plexus nerve block
Supraclavicular Brachial Plexus Block with KetamineDrug
Also called K group
drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1mg\kg ketamine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.
Device: ultrasound-guided supraclavicular Brachial Plexus nerve block
Supraclavicular Brachial Plexus Block with DexmedetomidineDrug
Also called D group
drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.
Device: ultrasound-guided supraclavicular Brachial Plexus nerve block
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Supraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline Receives: Drug: Supraclavicular Brachial Plexus Block with bupivacaine |
| Ketamine group | Active comparator | Supraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine Receives: Drug: Supraclavicular Brachial Plexus Block with Ketamine |
| Dexmedetomidine group | Active comparator | Supraclavicular Brachial Plexus Block using 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine Receives: Drug: Supraclavicular Brachial Plexus Block with Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate duration of sensory block
Sensory block duration: the time interval between the complete sensory block and complete resolution by hours
Measured: 24 hours after block
Secondary outcomes (5)
Evaluate onset of sensory and motor block
Onset time for sensory and motor block: the time interval between the end of local anesthetic administration and complete sensory and motor block by min.
Measured: 30 minute after block
Assess postoperative pain score
The severity of postoperative pain will be measured and recorded by using the visual analogue scale (VAP) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain
Measured: For 24 hours after surgery
time to first analgesic request
Time for the first request to rescue analgesia (in hours)
Measured: 24 hours
total analgesic requirements
Total diclofenac consumption requirements in 24 hours
Measured: 24 hours after surgery
sedation score
Ramsay Sedation Scale from 1-6 as follows: 1 = anxious, agitated, restless; 2 = cooperative, oriented, tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or loud noise; 5 =sluggish response; 6 = no response
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start21 Apr 2019
- Primary completion28 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraclavicular Brachial Plexus BlockStudies of the same condition, open and under way.
- More trials run by Minia 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, haidy salah mansour, Minia University
- Investigators
- Haidy S Mansour, MD, Principal investigator, assistant professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508894
- Sponsor's protocol ID
- 146:4/2019
- Status last verified
- Jul 2023
- First submitted
- 2 Aug 2020
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Versus Dexmedetomidine as an Adjuvant in Ultrasound-guided Supraclavicular Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT04508894
- Acronym / sponsor ID
- 146:4/2019
- Conditions
- Supraclavicular Brachial Plexus Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 21 Apr 2019 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 11 Aug 2020 (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.
Intervention model description: The patients were randomly classified into three groups using computer-generated table numbers each contain (25) patients.
Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine, Dexmedetomidine group (group D): 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine Control group (group C): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline. Masking: double-blind (participant and investigator) Masking Description: The investigator's study is a prospective, randomized, double-blind
Detailed description
This randomized, prospective, double-blind study was carried out on 75 ASA Physical Status I-II adults aged 18-75 years old scheduled to undergo elective and emergency forearm and hand surgeries under ultrasound-guided supraclavicular brachial plexus block. After obtaining the local ethics committee of El-Minia university hospital approval and written informed consent was taken of the patient, this study was conducted from April 2019 to February 2020 in El-Minia university hospital. The investigators excluded any patient with bleeding disorders, damage or disease of the brachial plexus, uncontrolled diabetes mellitus, and patients with neuromuscular diseases, Patients with a local skin infection at the site of injection or patients with known hypersensitivity to studied drugs.
Preoperative assessment and preparation: A careful assessment of medical history, general examination including chest, heart, abdomen, site of injection and other systems were carried out. Routine investigations were done as complete blood picture, ECG (electrocardiogram) renal and liver functions. An explanation of the visual analog scale was done to each patient.
Preparation of the studied medications: The patients were randomly classified into three groups using computer-generated table numbers each contains (25) patients. Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine, Dexmedetomidine group (group D) 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine (precedex® Hospira,Inc., Lake Forest USA).
Control group (group C) 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline. All medications were prepared in similar sterile coated bottles by the supervisor who didn't include in the anesthetic or operative team, 75 bottles numbered from 1 to 75 were prepared. After completion of the study, the key was opened by the supervisor Block technique: On patient's arrival to the operating room, a 20 G intravenous cannula was inserted in a peripheral vein of unaffected limb and standard monitoring commenced as noninvasive blood pressure (NIBP), (ECG), and Oxygen saturation (Spo2) (UltraviewSL2700, Spacelaps, USA), all equipment and drugs for general anesthesia and resuscitation were prepared, the ultrasound device (Sonosite, Nanomax, USA ) lubricating gel, 21guge 50 mm length, short bevel, insulated stimulating needle (Laboratoires pharmaceutiques, Vygon, France). Patient lie supine with the head turned to the other side and ipsilateral arm adducted gently with a flexed elbow. Under the complete aseptic condition, the identified area and the ultrasound probe was prepared with anti-septic (Povidone-Iodine 10%) solution and the skin infiltrated with 1-2 ml of lidocaine 2% solution subcutaneously, the brachial plexus was visualized by placing the transducer in the sagittal plane in the supraclavicular fossa behind the middle-third of the clavicle. Two distinct appearances of the supraclavicular brachial plexus was seen, it either appeared as a grape-like cluster of 5 to 6 hypoechoic circles, located lateral and superior to the subclavian artery between the anterior and middle scalene muscles at the lower cervical region or as 3 hypoechoic circles with hyperechoic outer rings, the predetermined volume of 40 mL of the study drug solution was administered around the brachial plexus after negative aspiration to avoid accidental intravascular injection, expansion of the brachial plexus sheath was considered as an indication of correct needle placement, multiple injections were used to deposit the total amount of the study drugs, skin massage for about 3 minutes was done to facilitate drug distribution.
Parameters assessed:
- Hemodynamic data: The hemodynamic variables as HR, MAP and Spo2 were assessed. The parameters were recorded preoperatively just before the block as a baseline value, at 5,10,20,30,60, 90 minutes during the operative time and at 1,2,4,6,9 and 12 hours after the end of the operation.
- Sensory block was assessed by pinprick test using a 3-point scale [16] Grade 0 = normal sensation, Grade 1 = loss of sensation of pinprick (analgesia), and Grade 2 = loss of sensation of touch (anesthesia).
- Motor block was determined by thumb abduction (radial nerve), thumb adduction (ulnar nerve), thumb opposition (median nerve), and flexion of elbow (musculocutaneous nerve) according to the modified Bromage 3 point scale: Grade 0: Normal motor function with full flexion and extension of elbow, wrist, and fingers. Grade 1: Decreased motor strength with the ability to move the fingers only. Grade 2: Complete motor block with an inability to move the fingers [16].
- Onset time for sensory and motor block: the time interval between the end of local anesthetic administration and complete sensory and motor block by min.
- Sensory block duration: the time interval between the complete sensory block and complete resolution of anesthesia on all the nerves (score 0(
- Motor block duration: the time interval from complete motor block to complete recovery of motor function of hand and forearm (grade 0) by hours.
- Visual analog scale (VAS): postoperative, the patients were familiarized with a 10-point visual analog scale (VAS) ranged from 0 = no pain, up to 10 = the worse imaginable pain. VAS was measured at 1, 2, 3, 6, 9, 12 hours. When it equals or >4 the investigators give IM diclofenac sodium (75 mg amp) (Voltaren, Novartis Pharmaceuticals Corporation, Switzerland).
- Time of first analgesic request: The time passed from supraclavicular brachial plexus block to the patient's first request for analgesic medication by hours
- Total analgesic requirements in 24 hours) diclofenac consumption)
- Sedation score: was assessed according to the modified Ramsay Sedation Scale 1987(RSS) from 1-6 as follows: 1 = anxious, agitated, restless; 2 = cooperative, oriented, tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or loud noise; 5 = sluggish response to light glabellar tap or loud noise; 6 = no response [17].
- Adverse effects: any adverse effects such as hypotension (i.e. 20% decrease relative to baseline), bradycardia (HR <60 beats/min), nausea, vomiting, hypoxemia (SpO2 <90%), local hematoma, hemothorax, pneumothorax, recurrent laryngeal nerve block, intravascular injection, Horner's syndrome and signs of local anesthetic toxicity were recorded during the operation and for 12 hours postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Supraclavicular Brachial Plexus Block with bupivacaineSupraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline |
| Ketamine group | Active comparator | Drug: Supraclavicular Brachial Plexus Block with KetamineSupraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine |
| Dexmedetomidine group | Active comparator | Drug: Supraclavicular Brachial Plexus Block with DexmedetomidineSupraclavicular Brachial Plexus Block using 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Physical Status I or II
- patients undergoing elective and emergency forearm and hand surgeries
Key exclusion criteria (6 listed)
- Patient with bleeding disorders
- Damage or disease of the brachial plexus
- Uncontrolled diabetes mellitus
- Patients with neuromuscular diseases
- Patients with a local skin infection at the site of injection
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 |
|---|---|---|
| Supraclavicular Brachial Plexus Block with bupivacaineAlso: C groupdrug: 20 ml 0.5%bupivacaine plus 20 ml 0.9% normal saline is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4. Device: ultrasound-guided supraclavicular Brachial Plexus nerve block | Drug | Control group |
| Supraclavicular Brachial Plexus Block with KetamineAlso: K groupdrug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1mg\kg ketamine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4. Device: ultrasound-guided supraclavicular Brachial Plexus nerve block | Drug | Ketamine group |
| Supraclavicular Brachial Plexus Block with DexmedetomidineAlso: D groupdrug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4. Device: ultrasound-guided supraclavicular Brachial Plexus nerve block | Drug | Dexmedetomidine group |
Primary outcome
Evaluate duration of sensory block
Time frame: 24 hours after block
Sensory block duration: the time interval between the complete sensory block and complete resolution by hours
5 secondary outcomes
Evaluate onset of sensory and motor block
Time frame: 30 minute after block
Assess postoperative pain score
Time frame: For 24 hours after surgery
time to first analgesic request
Time frame: 24 hours
total analgesic requirements
Time frame: 24 hours after surgery
sedation score
Time frame: 24 hours after surgery
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 1 Aug 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.
Haidy S Mansour, MD principal investigator
assistant professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supraclavicular Brachial Plexus Block with bupivacaine, Supraclavicular Brachial Plexus Block with Ketamine and Supraclavicular Brachial Plexus Block with Dexmedetomidine in people with Supraclavicular Brachial Plexus Block, run by Minia University at 1 site in Egypt.
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 2 inclusion and 6 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 1 Aug 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 Egypt. 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?
Evaluate duration of sensory block (time frame: 24 hours after block). 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 1 Aug 2023.