Post Operative Pain, AcuteNCT06423859
Articaine Plus Dexmedetomidine in Supraclavicular Block
A study testing Articaine and Dexmedetomidine in people with Post Operative Pain, Acute, run by Benha University at 1 site in Egypt.
Trial summary
Articaine has emerged as a local anesthetic (LA) that produces sensory and motor blockade shorter than bupivacaine and lower in neurotoxicity than lidocaine. Studies have shown that adding dexmedetomidine to LA produces prolongation of sensory and motor bock duration. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Operative Pain, Acute
- What is being tested?
- Articaine and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 20 Aug 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 18-60 years planned for upper limb surgery below the midhumerus with an expected time of less than 90 min usually under tourniquet.
Who cannot join
- allergies to local anesthetic,
- those with ASA III and IV,
- patients who refuse to participate,
- uncooperative patients,
- patients who have infection at the site of injection,
- patients who have bleeding disorder, and patients on anticoagulant drugs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Samar Rafik Mohamed Amin
Banhā, Qalyubia Governorate, 13511
Samar R. Amin, lecturer, 01287793991, samar.rafik@gmail.com
About this study
Official title: A Comparative Study Between Articaine Alone Versus Articaine Plus Dexmedetomidine for Ambulatory Orthopedic Surgery Under Supraclavicular Block
Articaine has emerged as a local anesthetic (LA) that produces sensory and motor blockade shorter than bupivacaine and lower in neurotoxicity than lidocaine.
Studies have shown that adding dexmedetomidine to LA produces prolongation of sensory and motor bock duration.
Early regain of motor power with adequate analgesia is needed in ambulatory surgery, for early start of physiotherapy. This study was designed to test efficacy of adding dexmedetomidine to articaine on the duration of sensory and motor block.
Read the detailed description
Articaine is an amide LA produced in the 1960s and first used in clinical trials in 1974. Although it is an amide that is similar to prilocaine in chemical structure, it contains a thiophene ring rather than a benzene ring. Articaine is a rapid and short acting LA, which has low neurotoxicity and appears to diffuse through tissues more readily than other commonly used LA agents. It is metabolized by nonspecific plasma esterases both in blood and tissues, leading to its rapid clearance.
α2-adrenergic receptor agonists have been the focus of interest for their sedative, analgesic, perioperative sympatholytic, and cardiovascular stabilizing effects along with providing reduction in anesthetic requirements. Dexmedetomidine may act on supraspinal (locus coeruleus) or spinal level or peripheral α2-adrenoreceptor to reduce nociceptive transmission, leading to analgesia.
Previous trials focused on adding dexmedetomidine to either levobupivacaine and bupivacaine, found augmentation of both sensory and motor block along with prolonged duration of effective analgesia. However, there remains limited knowledge of the analgesic efficacy and clinical utility of adding dexmedetomidine to articaine during peripheral nerve block in humans.
- Conditions
- Post Operative Pain, Acute
- Being tested
- Articaine, Dexmedetomidine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArticaineDrug
supraclavicular brachial plexus block with articaine 2%
DexmedetomidineDrug
supraclavicular brachial plexus block with articaine 2% in addition with Dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Articaine alone | Active comparator | supraclavicular brachial plexus block will be performed in this group guided by ultrasound. A 30 ml volume local anesthetic will be injected in the form of (29 cc articaine 2% + 1 cc isotonic saline) Receives: Drug: Articaine |
| Articaine and Dexmedetomidine | Experimental | supraclavicular brachial plexus block will be performed in this group guided by ultrasound. A 30 ml volume local anesthetic will be injected in the form of (29 cc articaine 2% + 1 cc volume of Dexmedetomidine 1 ug/kg) Receives: Drug: Articaine; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory block duration
the time between the onset of sensory block to the complete resolution of anesthesia on all nerves distribution.
Measured: 24 hours post block
Secondary outcomes (4)
onset time of sensory block
The time between the end of the drug injection and the total abolition of pinprick sensation along the distribution of any of nerves - median, ulnar, radial, or musculocutaneous
Measured: 15 minutes after block
onset time for motor block
the time between the end of the drug injection and Grade 1 motor block
Measured: 15 minutes after block
motor duration block
the time interval between the onset time of motor block and the recovery of complete motor function of that limb
Measured: 24 hours post block
Analgesia time
time interval between the administration of local anesthesia solution and onset of pain at surgical site
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Feb 2024
- Primary completion1 Aug 2024 (estimated)
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Benha 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423859
- Sponsor's protocol ID
- RC 19-1-2024
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Articaine Alone Versus Articaine Plus Dexmedetomidine for Ambulatory Orthopedic Surgery Under Supraclavicular Block
- ClinicalTrials.gov ID
- NCT06423859
- Acronym / sponsor ID
- RC 19-1-2024
- Conditions
- Post Operative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 21 May 2024 (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.
Articaine has emerged as a local anesthetic (LA) that produces sensory and motor blockade shorter than bupivacaine and lower in neurotoxicity than lidocaine.
Studies have shown that adding dexmedetomidine to LA produces prolongation of sensory and motor bock duration.
Early regain of motor power with adequate analgesia is needed in ambulatory surgery, for early start of physiotherapy. This study was designed to test efficacy of adding dexmedetomidine to articaine on the duration of sensory and motor block.
Detailed description
Articaine is an amide LA produced in the 1960s and first used in clinical trials in 1974. Although it is an amide that is similar to prilocaine in chemical structure, it contains a thiophene ring rather than a benzene ring. Articaine is a rapid and short acting LA, which has low neurotoxicity and appears to diffuse through tissues more readily than other commonly used LA agents. It is metabolized by nonspecific plasma esterases both in blood and tissues, leading to its rapid clearance.
α2-adrenergic receptor agonists have been the focus of interest for their sedative, analgesic, perioperative sympatholytic, and cardiovascular stabilizing effects along with providing reduction in anesthetic requirements. Dexmedetomidine may act on supraspinal (locus coeruleus) or spinal level or peripheral α2-adrenoreceptor to reduce nociceptive transmission, leading to analgesia.
Previous trials focused on adding dexmedetomidine to either levobupivacaine and bupivacaine, found augmentation of both sensory and motor block along with prolonged duration of effective analgesia. However, there remains limited knowledge of the analgesic efficacy and clinical utility of adding dexmedetomidine to articaine during peripheral nerve block in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Articaine alone | Active comparator | Drug: Articainesupraclavicular brachial plexus block will be performed in this group guided by ultrasound. A 30 ml volume local anesthetic will be injected in the form of (29 cc articaine 2% + 1 cc isotonic saline) |
| Articaine and Dexmedetomidine | Experimental | Drug: Articaine, Drug: Dexmedetomidinesupraclavicular brachial plexus block will be performed in this group guided by ultrasound. A 30 ml volume local anesthetic will be injected in the form of (29 cc articaine 2% + 1 cc volume of Dexmedetomidine 1 ug/kg) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- aged 18-60 years planned for upper limb surgery below the midhumerus with an expected time of less than 90 min usually under tourniquet.
Key exclusion criteria (6 listed)
- allergies to local anesthetic,
- those with ASA III and IV,
- patients who refuse to participate,
- uncooperative patients,
- patients who have 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 |
|---|---|---|
| Articainesupraclavicular brachial plexus block with articaine 2% | Drug | Articaine alone, Articaine and Dexmedetomidine |
| Dexmedetomidinesupraclavicular brachial plexus block with articaine 2% in addition with Dexmedetomidine | Drug | Articaine and Dexmedetomidine |
Primary outcome
Sensory block duration
Time frame: 24 hours post block
the time between the onset of sensory block to the complete resolution of anesthesia on all nerves distribution.
4 secondary outcomes
onset time of sensory block
Time frame: 15 minutes after block
onset time for motor block
Time frame: 15 minutes after block
motor duration block
Time frame: 24 hours post block
Analgesia time
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Articaine and Dexmedetomidine in people with Post Operative Pain, Acute, run by Benha 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 1 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: status not confirmed, as of the sponsor's last update on 23 May 2024. 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. 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?
Contact Samar R Amin, MD (+201287793991, samar.rafik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory block duration (time frame: 24 hours post 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 23 May 2024.