Evaluation of Adjuvant Use in Selective Trunk Block

NCT ID: NCT06540534

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-28
• Study Completion Date: 2023-12-10

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.

Conditions

Analgesia; Nerve Blocks; Postoperative Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Adjuvant-free selective trunks block

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.

Group Type: ACTIVE_COMPARATOR

kontrol group

Intervention Type: PROCEDURE

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

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)

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: PROCEDURE

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).

Interventions

Dexamethasone

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).

Intervention Type: PROCEDURE

kontrol 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.

Intervention Type: PROCEDURE

Other Intervention Names

adjuvant; salin group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gaziosmanpasa Research and Education Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 32909721 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35950709 (View on PubMed)

Other Identifiers

GaziosmanpasaTREHNA

Identifier Type: -

Identifier Source: org_study_id