Evaluation of Adjuvant Use in Selective Trunk Block

NCT06540534 | Completed

• 1 other identifier: GaziosmanpasaTREHNA
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

"Evaluation of the Anesthetic and Analgesic Efficacy of Dexamethasone in Selective Trunk Blocks

Conditions

Analgesia; Nerve Blocks; Postoperative Pain, Acute

Keywords

postoperative pain; postoperative analgesia; selective trunks block

Outcome Measures

Primary Outcomes (1)

• 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.

  first 30 minutes after the block aplication

Secondary Outcomes (2)

• postoperative total motor block duration and analgesia duration.

  within 24 hours after the surgery

• first postoperative rescue analgesia

  within 24 hours after the surgery hours

Study Arms (2)

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8 ml of the local anesthetic mixture to the lateral aspect of the superior trunk, the needle will be slightly withdrawn and directed towards the middle trunk where another 8 ml of the local anesthetic mixture will be administered.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.

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)

Procedure: Dexamethasone

Interventions

Dexamethasone 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).

Also known as: adjuvant

Adjuvant with selective trunks block

kontrol group 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.

Also known as: salin group

Adjuvant-free selective trunks block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Research and Education Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 32909721 BACKGROUND

• 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.

  PMID: 35950709 RESULT

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Dexamethasone; Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: April 28, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 10, 2023
• Last Updated: September 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)