Post Operative PainNCT06779604
Dexmedetomidine and Dexamethasone Added as Adjuvant Infraclavicular Brachial Plexus Block in Upper Limb Surgery
An observational study of Post Operative Pain and Anesthesia, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of dexmedetomidine and dexamethasone added during USG-guided infraclavicular block on block onset time, total block time and time to first analgesic need in patients undergoing upper extremity surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Operative Pain, Anesthesia, Acute Pain
- What is being tested?
- Infraclavicular Block with Dexmedetomidine and Dexamethasone
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 30 Jul 2026
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 44 adult patients 18 to 70 years, American Society of Anesthesiologists (ASA) I-II who underwent upper extremity surgery were included in Orthopedics and Traumatology Clinic.
Who may be able to join
- 18-70 years
- ASA I-II
Who cannot join
- Under 18 years of age and older than 70 years of age,
- presence of brachial plexus injury,
- patients with bleeding diathesis,
- presence of allergy, -contralateral diaphragmatic paralysis, -
- presence of nerve injury secondary to trauma,
- pre-existing neuropathy of the surgical extremity,
Show all 20Show fewer
- presence of severe pulmonary,
- renal and hepatic disease,
- congestive heart failure (NYHA stage 3-4),
- uncontrolled diabetes mellitus,
- history of neuromuscular disease,
- patients with extreme obesity or malnutrition (BMI > 30 kg-1m2 or BMI <20 kg-1m2),
- presence of epilepsy,
- history of peripheral vascular disease,
- history of chronic pain or fibromyalgia,
- pregnant and lactating patients,
- patients with local infection at the injection site,
- patients undergoing general anesthesia due to inadequacy of the block,
- patients refusing to give informed consent,
- history of recreational substance use, and chronic narcotic-based painkillers
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Umraniye Education and Research Hospital
Istanbul, Umraniye, 34034
About this study
Official title: Comparison of the Anesthetic Effects of Dexmedetomidine and Dexamethasone Added as Adjuvant to Ultrasonography-Guided Infraclavicular Brachial Plexus Block in Upper Limb Surgery
The aim of this study was to investigate the effect of dexmedetomidine and dexamethasone added during USG-guided infraclavicular block on block onset time, total block time and time to first analgesic need in patients undergoing upper extremity surgery.
Read the detailed description
Brachial plexus blocks are successfully applied for perioperative/postoperative analgesia in upper extremity surgical procedures. These blocks include infraclavicular, supraclavicular, interscalene, and axillary blocks. The reason why infraclavicular block is preferred is that it provides comprehensive anesthesia/analgesia of the upper extremity. While the axillary approach may fail to block the musculocutaneous nerve that causes tourniquet pain, the interscalene and supraclavicular approaches generally fail to provide anesthesia in the distribution of the ulnar nerve. Other advantages include the lower risk of lung and pleural puncture compared to interscalene and supraclavicular blocks and the lower probability of injury to neurovascular structures due to the location of the block, unlike the interscalene approach.
Local anesthetics are used to block conduction in nerve fibers during brachial plexus blocks. Studies have shown that the commonly used bupivacaine and ropivacaine 0.25% concentrations are not recommended for anesthesia. Bupivacaine 0.5% and ropivacaine 0.5% have been shown to be similar in terms of sensory and motor block onset time, total sensory and motor block duration, analgesia duration, anesthesia duration, paresis and paralysis incidence. The minimum dose of bupivacaine 0.5% required for complete sensory block was determined as 14mL, but the onset time of the block performed at this low dose was recorded as a late onset of 40 minutes (30-45 minutes). It was observed that the onset time decreased to as short as 15 minutes (min) after the application of 30mL bupivacaine 0.5%. In order to reduce the amount of local anesthetic used, to avoid local anesthetic toxicity, to shorten the block onset time and to extend the postoperative analgesia period, a different local anesthetic or adjuvants were used together with bupivacaine. Bupivacaine used with lidocaine has been observed to have a faster onset of action. Other adjuvants added to accelerate the onset of block and improve the quality of the block include alpha-2 agonists (clonidine and dexmedetomidine), opioids (fentanyl and tramadol), and steroids (dexamethasone). Dexmedetomidine is an adjuvant that is an alpha-2 adrenergic agonist and has been observed to have a synergistic effect with local anesthetics and to prolong their duration of activity. The addition of dexmedetomidine 50 µg and 75 µg has been associated with a decrease in the time to onset of sensory and motor block, a decrease in postoperative morphine consumption, and an increase in the duration of sensory block, motor block, and the time to first morphine request. Dexmedetomidine 75 µg has been associated with an increased incidence of preoperative and intraoperative hypotension episodes. Dexamethasone, a perineural adjuvant, has been shown in many studies to significantly shorten the onset of sensory and motor block and prolong the duration of analgesia. Perineural dexamethasone is more commonly used intravenously for block. Currently, many studies have compared the effects of various perineural dexamethasone doses, such as 1 mg, 2 mg, 4 mg, 5 mg and 8 mg, on block, but the results remain controversial. Studies have shown that there is no difference in safety and efficacy between 4 and 8 mg perineural dexamethasone. Another study reported that 4 mg perineural dexamethasone constitutes a ceiling dose for prolonging the duration of analgesia when used with local anesthetics for block.
- Conditions
- Post Operative Pain, Anesthesia, Acute Pain
- Being tested
- Infraclavicular Block with Dexmedetomidine and Dexamethasone
- Keywords
- infraclavicular nerve block, dexmetomidine, dexamethosone
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraclavicular Block with Dexmedetomidine and DexamethasoneProcedure or surgery
Infraclavicular block with Dexmedetomidine and Dexamethasone was performed at least 30 min before the start of the operation. The patient was positioned in a supine position arms at the sides or in 90 degree abduction, head turned to the other side. Infraclavicular block was performed with the lateral sagittal technique, while the USG probe was placed under the clavicle and medial to the coracoid process, providing a brachial plexus image in the form of a hyperechoic outer ring and hypoechoic circles, like a classic honeycomb image. A local anesthetic mixture was injected with a 100 mm block needle with negative aspiration and its spread in tissue planes was observed.
If the VAS score was 3 or above, tramadol 1 mg kg-1 was administered as an analgesic drug.
| Study group | Role | What they receive |
|---|---|---|
| Group Dexmedetomidine: (n:22) | A total volume of 30 mL of 0.5% bupivacaine, 14 mL of 2% lidocaine and 50 μgr of dexmedetomidine in 1 mL of normal saline is administered to the patients. Receives: Procedure: Infraclavicular Block with Dexmedetomidine and Dexamethasone | |
| GroupDexamethasone: (n:22) | Patients are administered 0.5% bupivacaine 15 mL, 2% lidocaine 14 mL and 4 mg dexamethasone in 1 ml normal saline with a total volume of 30 mL Receives: Procedure: Infraclavicular Block with Dexmedetomidine and Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
infraclavicular block onset time
Sensory block / motor block onset time
Measured: 24 -48 hours
postoperative analgesic drug requirement
opioid total amount micrograms
Measured: 24 -48 hours
infraclavicular total block time
block time hours
Measured: 24 -48 hours
Secondary outcomes (2)
investigate the effects on VAS score and sedation level in the first 24 hours postoperatively
VAS score
Measured: 24 -48 hours
advers event Perioperative and postoperative period
Nausea,Vomiting,Hypotension,Bradycardia, Nerve damage
Measured: 24 -48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Feb 2026
- Primary completion30 Jun 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeliha Alicikus, Umraniye Education and Research Hospital
- Investigators
- ZELİHA TUNCEL, ASC PROF, Study director, Umraniye ERH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779604
- Sponsor's protocol ID
- UERH-AR-ZT-11
- Status last verified
- Oct 2026
- First submitted
- 22 Dec 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Anesthetic Effects of Dexmedetomidine and Dexamethasone Added as Adjuvant to Ultrasonography-Guided Infraclavicular Brachial Plexus Block in Upper Limb Surgery
- ClinicalTrials.gov ID
- NCT06779604
- Acronym / sponsor ID
- UERH-AR-ZT-11
- Conditions
- Post Operative Pain, Anesthesia, Acute Pain
- Keywords
- infraclavicular nerve block, dexmetomidine, dexamethosone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 16 Jan 2025 (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 study was to investigate the effect of dexmedetomidine and dexamethasone added during USG-guided infraclavicular block on block onset time, total block time and time to first analgesic need in patients undergoing upper extremity surgery.
Detailed description
Brachial plexus blocks are successfully applied for perioperative/postoperative analgesia in upper extremity surgical procedures. These blocks include infraclavicular, supraclavicular, interscalene, and axillary blocks. The reason why infraclavicular block is preferred is that it provides comprehensive anesthesia/analgesia of the upper extremity. While the axillary approach may fail to block the musculocutaneous nerve that causes tourniquet pain, the interscalene and supraclavicular approaches generally fail to provide anesthesia in the distribution of the ulnar nerve. Other advantages include the lower risk of lung and pleural puncture compared to interscalene and supraclavicular blocks and the lower probability of injury to neurovascular structures due to the location of the block, unlike the interscalene approach.
Local anesthetics are used to block conduction in nerve fibers during brachial plexus blocks. Studies have shown that the commonly used bupivacaine and ropivacaine 0.25% concentrations are not recommended for anesthesia. Bupivacaine 0.5% and ropivacaine 0.5% have been shown to be similar in terms of sensory and motor block onset time, total sensory and motor block duration, analgesia duration, anesthesia duration, paresis and paralysis incidence. The minimum dose of bupivacaine 0.5% required for complete sensory block was determined as 14mL, but the onset time of the block performed at this low dose was recorded as a late onset of 40 minutes (30-45 minutes). It was observed that the onset time decreased to as short as 15 minutes (min) after the application of 30mL bupivacaine 0.5%. In order to reduce the amount of local anesthetic used, to avoid local anesthetic toxicity, to shorten the block onset time and to extend the postoperative analgesia period, a different local anesthetic or adjuvants were used together with bupivacaine. Bupivacaine used with lidocaine has been observed to have a faster onset of action. Other adjuvants added to accelerate the onset of block and improve the quality of the block include alpha-2 agonists (clonidine and dexmedetomidine), opioids (fentanyl and tramadol), and steroids (dexamethasone). Dexmedetomidine is an adjuvant that is an alpha-2 adrenergic agonist and has been observed to have a synergistic effect with local anesthetics and to prolong their duration of activity. The addition of dexmedetomidine 50 µg and 75 µg has been associated with a decrease in the time to onset of sensory and motor block, a decrease in postoperative morphine consumption, and an increase in the duration of sensory block, motor block, and the time to first morphine request. Dexmedetomidine 75 µg has been associated with an increased incidence of preoperative and intraoperative hypotension episodes. Dexamethasone, a perineural adjuvant, has been shown in many studies to significantly shorten the onset of sensory and motor block and prolong the duration of analgesia. Perineural dexamethasone is more commonly used intravenously for block. Currently, many studies have compared the effects of various perineural dexamethasone doses, such as 1 mg, 2 mg, 4 mg, 5 mg and 8 mg, on block, but the results remain controversial. Studies have shown that there is no difference in safety and efficacy between 4 and 8 mg perineural dexamethasone. Another study reported that 4 mg perineural dexamethasone constitutes a ceiling dose for prolonging the duration of analgesia when used with local anesthetics for block.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Dexmedetomidine: (n:22) | – | Procedure: Infraclavicular Block with Dexmedetomidine and DexamethasoneA total volume of 30 mL of 0.5% bupivacaine, 14 mL of 2% lidocaine and 50 μgr of dexmedetomidine in 1 mL of normal saline is administered to the patients. |
| GroupDexamethasone: (n:22) | – | Procedure: Infraclavicular Block with Dexmedetomidine and DexamethasonePatients are administered 0.5% bupivacaine 15 mL, 2% lidocaine 14 mL and 4 mg dexamethasone in 1 ml normal saline with a total volume of 30 mL |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 44 adult patients 18 to 70 years, American Society of Anesthesiologists (ASA) I-II who underwent upper extremity surgery were included in Orthopedics and Traumatology Clinic.
Key inclusion criteria (2 listed)
- 18-70 years
- ASA I-II
Key exclusion criteria (20 listed)
- Under 18 years of age and older than 70 years of age,
- presence of brachial plexus injury,
- patients with bleeding diathesis,
- presence of allergy, -contralateral diaphragmatic paralysis, -
- presence of nerve injury secondary to trauma,
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 |
|---|---|---|
| Infraclavicular Block with Dexmedetomidine and DexamethasoneInfraclavicular block with Dexmedetomidine and Dexamethasone was performed at least 30 min before the start of the operation. The patient was positioned in a supine position arms at the sides or in 90 degree abduction, head turned to the other side. Infraclavicular block was performed with the lateral sagittal technique, while the USG probe was placed under the clavicle and medial to the coracoid process, providing a brachial plexus image in the form of a hyperechoic outer ring and hypoechoic circles, like a classic honeycomb image. A local anesthetic mixture was injected with a 100 mm block needle with negative aspiration and its spread in tissue planes was observed. If the VAS score was 3 or above, tramadol 1 mg kg-1 was administered as an analgesic drug. | Procedure or surgery | Group Dexmedetomidine: (n:22), GroupDexamethasone: (n:22) |
Primary outcome
infraclavicular block onset time
Time frame: 24 -48 hours
Sensory block / motor block onset time
postoperative analgesic drug requirement
Time frame: 24 -48 hours
opioid total amount micrograms
infraclavicular total block time
Time frame: 24 -48 hours
block time hours
2 secondary outcomes
investigate the effects on VAS score and sedation level in the first 24 hours postoperatively
Time frame: 24 -48 hours
advers event Perioperative and postoperative period
Time frame: 24 -48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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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.
ZELİHA TUNCEL, ASC PROF study director
Umraniye ERH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Pain and Anesthesia, run by Umraniye Education and Research Hospital 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 2 inclusion and 20 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infraclavicular block onset time (time frame: 24 -48 hours). The study lists 3 primary outcomes in all. 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 6 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.