Efficacy of Variable Volume Truncal Blocks in Upper Limb Orthopedic Surgery

NCT06664203 | Recruiting

• 1 other identifier: GaziosmanpasaTREH-SeTb
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

aim of this study is to compare the effect of selective truncal blocks, performed at different doses and volumes, on the onset times of motor and sensory blocks required for anesthesia in patients scheduled for hand, wrist, forearm, and elbow surgeries. Completing the operation under regional anesthesia will be considered a successful block.

Conditions

Pain Management; Anaesthesia Complication

Keywords

postoperative pain; selective turuncus block; arm anaesthesia

Outcome Measures

Primary Outcomes (1)

• on the onset times of motor and sensory blocks required for anesthesia

  The primary outcome of this study is to compare the effect of selective truncal blocks, performed at different doses and volumes, on the onset times of motor and sensory blocks required for anesthesia in patients scheduled for hand, wrist, forearm, and elbow surgeries. Completing the operation under regional anesthesia will be considered a successful block.

  24 hour

Secondary Outcomes (3)

• Total Opioid Consumption

  24 hour

• time to first rescue analgesic requirement.

  24 hour

• diaphragm paralysis

  24 hour

Study Arms (2)

with 15 ml SeTb group

ACTIVE COMPARATOR

This group will receive a SeTB (Selective Trunk Block) with a total of 15 ml of bupivacaine

Procedure: Selective turuncus block with 15 ml bupivacain

With 25 ml bupivacain SeTb

ACTIVE COMPARATOR

This group will receive a SeTB (Selective Trunk Block) with a total of 25 ml of bupivacaine

Procedure: Selective turuncus block with 25 ml bupivacain

Interventions

Selective turuncus block with 25 ml bupivacain PROCEDURE

A high-frequency linear ultrasound (USG) probe will be used to locate the C7 transverse process, which will serve as a sonoanatomic landmark. Once the C5 ventral ramus is identified at the C7 transverse process level, the linear probe will be slightly caudally angled to visualize the C6 ventral ramus. The area where the superior trunk is formed by C5 and C6 will be examined with the USG probe until the superior trunk is visualized. Below the superior trunk, the middle trunk and the C8 ventral ramus will be visible. In Group 1, a total of 23 ml of 0.5% bupivacaine plus 2 ml (8 mg dexamethasone) will be used as the local anesthetic mixture, totaling 25ml. 7ml of the local anesthetic mixture will be injected into the superior trunk, the middle trunk for an additional 8 ml. The probe will then be directed caudally to obtain an optimal view of the lower trunk, where 10 ml of the same mixture will be injected close to the lower trunk.

With 25 ml bupivacain SeTb

Selective turuncus block with 15 ml bupivacain PROCEDURE

In Group 2, 13 ml of 0.5% bupivacaine plus 2 ml (8 mg dexamethasone) will be used, totaling 15 ml. In Group 2, 5 ml of the local anesthetic mixture will be injected into the superior trunk, followed by 5 ml into the middle trunk and 5 ml into the lower trunk, as in Group II.

with 15 ml SeTb group

Eligibility Criteria

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

You may qualify if:

• ASA 1-2
• Body Mass Index (BMI) of 18-35 kg/m²
• Age: 18-65 years -Patients undergoing all upper extremity orthopedic surgeries, except shoulder surgeries (distal humerus, elbow, forearm, hand, and wrist), will be included. -

You may not qualify if:

• Patient refusal
• Pregnancy or breastfeeding
• Severe pulmonary disease
• Contralateral diaphragm paralysis
• Nerve injury secondary to trauma
• Neuromuscular disease
• Peripheral neuropathy
• Bleeding diathesis
• Allergy to local anesthetics and dexamethasone
• Uncontrolled diabetes mellitus
• Morbid obesity with BMI \>35
• Severe cardiovascular, renal, or hepatic disease
• Infection at the site of the nerve block

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Research and Training Hospital

Istanbul, 34255, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Sivashanmugam T, Sripriya R, John Paul S, Ravishankar M. Estimation of minimum effective local anaesthetic volume to block the lower trunk during selective truncal injection brachial plexus block. Indian J Anaesth. 2022 Aug;66(Suppl 5):S281-S283. doi: 10.4103/ija.ija_1087_21. Epub 2022 Aug 12. No abstract available.

  PMID: 36262721 RESULT

• Bao X, Huang J, Feng H, Qian Y, Wang Y, Zhang Q, Hu H, Wang X. Effect of local anesthetic volume (20 mL vs 30 mL ropivacaine) on electromyography of the diaphragm and pulmonary function after ultrasound-guided supraclavicular brachial plexus block: a randomized controlled trial. Reg Anesth Pain Med. 2019 Jan;44(1):69-75. doi: 10.1136/rapm-2018-000014.

  PMID: 30640655 RESULT

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

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

Study Officials

• Serpil Sehirlioglu, MD

  Gaziosmanpasa Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

serpil Sehirlioglu, MD

CONTACT

+905054431852; drserpilsahin@gmail.com

DONDU GENC MORALAR, MD

CONTACT

+905053737913; dondugencm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal invertigator

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 29, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: FİRST 5 YEARS
• Access Criteria: drserpilsahin@gmail.com

Locations

TU (1)