AnalgesiaNCT06540534
Evaluation of Adjuvant Use in Selective Trunk Block
A study testing Dexamethasone and kontrol group in people with Analgesia and Nerve Blocks, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
"Evaluation of the Anesthetic and Analgesic Efficacy of Dexamethasone in Selective Trunk Blocks Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Nerve Blocks, Postoperative Pain, Acute
- What is being tested?
- Dexamethasone and kontrol group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2023to 10 Dec 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
- Patients undergoing upper extremity surgery with ASA (American Society of Anesthesiologists) classification I-II
- aged 18-65 years, and with a body mass index (BMI) between 18-35 kg/m² were included in the study.
Who cannot join
- included ASA III-IV patients
- those who refuse the block
- pregnant and breastfeeding women
- individuals with severe lung disease
- contralateral diaphragm paralysis
- nerve injury secondary to trauma
Show all 14Show fewer
- neuromuscular diseases,
- peripheral neuropathy
- bleeding diathesis
- history of anticoagulant use
- allergies to local anesthetics or dexamethasone
- uncontrolled diabetes mellitus
- morbid obesity with BMI >35 kg/m²
- severe cardiovascular, renal, or liver disease, and infections at the site where the nerve block is to be applied.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Research and Education Hospital
Istanbul, 34000
About this study
Official title: Comparison of Anesthetic and Analgesic Efficacy of Dexamethasone as an Adjuvant in Selective Trunk Block
"Evaluation of the Anesthetic and Analgesic Efficacy of Dexamethasone in Selective Trunk Blocks
Read the detailed description
the investigators hypothesize that the perineural application of dexamethasone as an adjuvant in selective trunk block for upper extremity surgeries will accelerate the onset time of anesthesia and analgesia, provide significant anesthetic and analgesic effects, and prolong the duration of anesthesia and analgesia.
In recent years, the brachial plexus block, performed with various approaches, has been preferred over general anesthesia for upper extremity orthopedic surgeries due to its numerous advantages. It maintains the patient's consciousness and spontaneous respiration, reduces airway interventions, provides effective postoperative pain control, minimizes opioid-related side effects, limits surgery-related metabolic and endocrine changes, enables early discharge, and reduces treatment costs.
Selective trunk block offers rapid block onset and high success rates. The use of ultrasound in peripheral blocks has also reduced the risk of various complications (e.g., vascular injury). The selective trunk approach, as described by Manoj Kumar Karmakar in 2020, involves blocking the upper, middle, and lower trunks at the C7 transverse process level, resulting in sensory/motor block in all ipsilateral upper extremity dermatomes except T2. This study aims to compare the anesthetic and analgesic efficacy of dexamethasone as an adjuvant to bupivacaine in the selective trunk block approach.
Dexamethasone is a widely used glucocorticoid with anti-inflammatory, anti-toxic, and other effects. It has strong lipophilic properties, is soluble in fat, increases pH, facilitates the penetration of local anesthetics into nerve sheaths, and extends the duration of local anesthetic effects, as supported by various studies. Additionally, dexamethasone is commonly used in pain management for its neuromodulatory effects.
- Conditions
- Analgesia, Nerve Blocks, Postoperative Pain, Acute
- Being tested
- Dexamethasone, kontrol group
- Keywords
- postoperative pain, postoperative analgesia, selective trunks block
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneProcedure or surgery
Also called adjuvant
In the adjuvan group (dexamethasone)group, a total of 25 ml of local anesthetic mixture will be applied, consisting of 23 ml of 0.5% bupivacaine and 2 ml of dexamethasone(8mg).
kontrol groupProcedure or surgery
Also called salin group
In the control group, a total of 25 ml of local anesthetic mixture will be applied, consisting of 23 ml of 0.5% bupivacaine and 2 ml of 0.9% saline.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant-free selective trunks block | Active comparator | In the selective trunk approach,Once the C6 and C5 ventral rami are identified at the level of the C7 transverse process, the probe will be slightly directed caudally to visualize the C6 ventral ramus. Caudal to the superior trunk, the middle trunk and the C8 ventral ramus will be visualized. The T1 ventral ramus can be seen on the 1st rib with the probe directed caudally. After administering 8 ml of the local anesthetic mixture to the lateral aspect of the superior trunk, the needle will be slightly withdrawn and directed towards the middle trunk where another 8 ml of the local anesthetic mixture will be administered. The probe will then be directed caudally to obtain an optimal view of the inferior trunk, and 9 ml of local anesthetic will be administered near the inferior trunk.
In the control group, a total of 25 ml of local anesthetic mixture will be applied, consisting of 23 ml of 0.5% bupivacaine and 2 ml of 0.9% saline. Receives: Procedure: kontrol group |
| Adjuvant with selective trunks block | Active comparator | In the selective trunk approach, Once the C6 and C5 ventral rami are identified at the level of the C7 transverse process, the probe will be slightly directed caudally to visualize the C6 ventral ramus. The probe will be used to scan until the area where the upper trunks of C5 and C6 are formed is observed. Caudal to the superior trunk, the middle trunk and the C8 ventral ramus will be visualized. After administering 8 ml of the local anesthetic mixture to the lateral aspect of the superior trunk, the needle will be slightly withdrawn and directed towards the middle trunk where another 8 ml of the local anesthetic mixture will be administered. The probe will then be directed caudally to obtain an optimal view of the inferior trunk, and 9 ml of local anesthetic will be administered near the inferior trunk.
In the dexamethasone group, a total of 25 ml of local anesthetic mixture will be applied, consisting of 23 ml of 0.5% bupivacaine and 8 mg (2 ml of deksamethasone) Receives: Procedure: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
onset times of motor and sensory blocks
primary aim is to compare the effects of adding dexamethasone as an adjuvant to bupivacaine in selective trunk blocks on the onset times of motor and sensory blocks required for anesthesia.
Measured: first 30 minutes after the block aplication
Secondary outcomes (2)
postoperative total motor block duration and analgesia duration.
To compare the effects of dexamethasone as an adjuvant on postoperative total motor block duration and analgesia duration
Measured: within 24 hours after the surgery
first postoperative rescue analgesia
To evaluate the time to the first postoperative rescue analgesia
Measured: within 24 hours after the surgery hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start28 Apr 2023
- Primary completion1 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540534
- Sponsor's protocol ID
- GaziosmanpasaTREHNA
- Status last verified
- Jul 2024
- First submitted
- 2 Aug 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karmakar MK, Areeruk P, Mok LYH, Sivakumar RK. Ultrasound-Guided Selective Trunk Block to Produce Surgical Anesthesia of the Whole Upper Extremity: A Case Report. A A Pract. 2020 Jul;14(9):e01274. doi: 10.1213/XAA.0000000000001274.
PubMed 32909721Sivakumar RK, Samy W, Pakpirom J, Songthamwat B, Karmakar MK. Ultrasound-guided selective trunk block: Evaluation of ipsilateral sensorimotor block dynamics, hemidiaphragmatic function and efficacy for upper extremity surgery. A single-centre cohort study. Eur J Anaesthesiol. 2022 Oct 1;39(10):801-809. doi: 10.1097/EJA.0000000000001736. Epub 2022 Aug 11.
PubMed 35950709
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anesthetic and Analgesic Efficacy of Dexamethasone as an Adjuvant in Selective Trunk Block
- ClinicalTrials.gov ID
- NCT06540534
- Acronym / sponsor ID
- GaziosmanpasaTREHNA
- Conditions
- Analgesia, Nerve Blocks, Postoperative Pain, Acute
- Keywords
- postoperative pain, postoperative analgesia, selective trunks block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 6 Aug 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.
"Evaluation of the Anesthetic and Analgesic Efficacy of Dexamethasone in Selective Trunk Blocks
Detailed description
the investigators hypothesize that the perineural application of dexamethasone as an adjuvant in selective trunk block for upper extremity surgeries will accelerate the onset time of anesthesia and analgesia, provide significant anesthetic and analgesic effects, and prolong the duration of anesthesia and analgesia.
In recent years, the brachial plexus block, performed with various approaches, has been preferred over general anesthesia for upper extremity orthopedic surgeries due to its numerous advantages. It maintains the patient's consciousness and spontaneous respiration, reduces airway interventions, provides effective postoperative pain control, minimizes opioid-related side effects, limits surgery-related metabolic and endocrine changes, enables early discharge, and reduces treatment costs.
Selective trunk block offers rapid block onset and high success rates. The use of ultrasound in peripheral blocks has also reduced the risk of various complications (e.g., vascular injury). The selective trunk approach, as described by Manoj Kumar Karmakar in 2020, involves blocking the upper, middle, and lower trunks at the C7 transverse process level, resulting in sensory/motor block in all ipsilateral upper extremity dermatomes except T2. This study aims to compare the anesthetic and analgesic efficacy of dexamethasone as an adjuvant to bupivacaine in the selective trunk block approach.
Dexamethasone is a widely used glucocorticoid with anti-inflammatory, anti-toxic, and other effects. It has strong lipophilic properties, is soluble in fat, increases pH, facilitates the penetration of local anesthetics into nerve sheaths, and extends the duration of local anesthetic effects, as supported by various studies. Additionally, dexamethasone is commonly used in pain management for its neuromodulatory effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant-free selective trunks block | Active comparator | Procedure: kontrol groupIn the selective trunk approach,Once the C6 and C5 ventral rami are identified at the level of the C7 transverse process, the probe will be slightly directed caudally to visualize the C6 ventral ramus. Caudal to the superior trunk, the middle trunk and the C8 ventral ramus will be visualized. The T1 ventral ramus can be seen on the 1st rib with the probe directed caudally. After administering 8 ml of the local anesthetic mixture to the lateral aspect of the superior trunk, the needle will be slightly withdrawn and directed towards the middle trunk where another 8 ml of the local anesthetic mixture will be administered. The probe will then be directed caudally to obtain an optimal view of the inferior trunk, and 9 ml of local anesthetic will be administered near the inferior trunk. In the control group, a total of 25 ml of local anesthetic mixture will be applied, consisting of 23 ml of 0.5% bupivacaine and 2 ml of 0.9% saline. |
| Adjuvant with selective trunks block | Active comparator | Procedure: DexamethasoneIn the selective trunk approach, Once the C6 and C5 ventral rami are identified at the level of the C7 transverse process, the probe will be slightly directed caudally to visualize the C6 ventral ramus. The probe will be used to scan until the area where the upper trunks of C5 and C6 are formed is observed. Caudal to the superior trunk, the middle trunk and the C8 ventral ramus will be visualized. After administering 8 ml of the local anesthetic mixture to the lateral aspect of the superior trunk, the needle will be slightly withdrawn and directed towards the middle trunk where another 8 ml of the local anesthetic mixture will be administered. The probe will then be directed caudally to obtain an optimal view of the inferior trunk, and 9 ml of local anesthetic will be administered near the inferior trunk. In the dexamethasone group, a total of 25 ml of local anesthetic mixture will be applied, consisting of 23 ml of 0.5% bupivacaine and 8 mg (2 ml of deksamethasone) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing upper extremity surgery with ASA (American Society of Anesthesiologists) classification I-II
- aged 18-65 years, and with a body mass index (BMI) between 18-35 kg/m² were included in the study.
Key exclusion criteria (14 listed)
- included ASA III-IV patients
- those who refuse the block
- pregnant and breastfeeding women
- individuals with severe lung disease
- contralateral diaphragm paralysis
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 |
|---|---|---|
| DexamethasoneAlso: adjuvantIn the adjuvan group (dexamethasone)group, a total of 25 ml of local anesthetic mixture will be applied, consisting of 23 ml of 0.5% bupivacaine and 2 ml of dexamethasone(8mg). | Procedure or surgery | Adjuvant with selective trunks block |
| kontrol groupAlso: salin groupIn the control group, a total of 25 ml of local anesthetic mixture will be applied, consisting of 23 ml of 0.5% bupivacaine and 2 ml of 0.9% saline. | Procedure or surgery | Adjuvant-free selective trunks block |
Primary outcome
onset times of motor and sensory blocks
Time frame: first 30 minutes after the block aplication
primary aim is to compare the effects of adding dexamethasone as an adjuvant to bupivacaine in selective trunk blocks on the onset times of motor and sensory blocks required for anesthesia.
2 secondary outcomes
postoperative total motor block duration and analgesia duration.
Time frame: within 24 hours after the surgery
first postoperative rescue analgesia
Time frame: within 24 hours after the surgery 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 24 Sep 2024.
- Background: PubMed 32909721Karmakar MK, Areeruk P, Mok LYH, Sivakumar RK. Ultrasound-Guided Selective Trunk Block to Produce Surgical Anesthesia of the Whole Upper Extremity: A Case Report. A A Pract. 2020 Jul;14(9):e01274. doi: 10.1213/XAA.0000000000001274.
- Results publication: PubMed 35950709Sivakumar RK, Samy W, Pakpirom J, Songthamwat B, Karmakar MK. Ultrasound-guided selective trunk block: Evaluation of ipsilateral sensorimotor block dynamics, hemidiaphragmatic function and efficacy for upper extremity surgery. A single-centre cohort study. Eur J Anaesthesiol. 2022 Oct 1;39(10):801-809. doi: 10.1097/EJA.0000000000001736. Epub 2022 Aug 11.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and kontrol group in people with Analgesia and Nerve Blocks, run by Gaziosmanpasa Research and Education 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 14 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 24 Sep 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 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?
onset times of motor and sensory blocks (time frame: first 30 minutes after the block aplication). 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 NCT06540534, which also lists 2 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 24 Sep 2024.