Clinical trial NCT06540534: Evaluation of Adjuvant Use in Selective Trunk Block
Official title: Comparison of Anesthetic and Analgesic Efficacy of Dexamethasone as an Adjuvant in Selective Trunk Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Nerve Blocks
Postoperative Pain, Acute
Keywords: postoperative pain
postoperative analgesia
selective trunks block
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-06
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: "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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion criteria:

* 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
* 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.

Primary outcomes:
measure: onset times of motor and sensory blocks
timeFrame: first 30 minutes after the block aplication
Secondary outcomes:
measure: postoperative total motor block duration and analgesia duration.
timeFrame: within 24 hours after the surgery
measure: first postoperative rescue analgesia
timeFrame: within 24 hours after the surgery hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Research and Education Hospital
Study officials:
References:
citation: 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.
citation: Sivakumar 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.