Evaluation of Adjuvant Use in Selective Trunk Block

September 21, 2024 updated by: Gaziosmanpasa Research and Education Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34000
        • Gaziosmanpasa Research and Education Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Other Names:
  • salin group
Active Comparator: 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)
Procedure: 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).
Other Names:
  • adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
first 30 minutes after the block aplication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 24 hours after the surgery
first postoperative rescue analgesia
Time Frame: within 24 hours after the surgery hours
To evaluate the time to the first postoperative rescue analgesia
within 24 hours after the surgery hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziosmanpasa Research and Education Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 10, 2023

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 21, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GaziosmanpasaTREHNA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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