Skip to main content
OpenTrials
Completed

NCT Number: NCT06540534

Evaluation of Adjuvant Use in Selective Trunk Block

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa Research and Education Hospital

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: adjuvant

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.

Other names: salin group

Primary outcomes

  1. 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.

Secondary outcomes

  1. postoperative total motor block duration and analgesia duration.

    Time frame: within 24 hours after the surgery

    To compare the effects of dexamethasone as an adjuvant on postoperative total motor block duration and analgesia duration

  2. first postoperative rescue analgesia

    Time frame: within 24 hours after the surgery hours

    To evaluate the time to the first postoperative rescue analgesia

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

Comparison of Anesthetic and Analgesic Efficacy of Dexamethasone as an Adjuvant in Selective Trunk Block

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 6, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.