Upper Trunk Block Feasibility by Anesthesia Residents

NCT05932186 | Unknown Phase 4

• 1 other identifier: 0306047
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study compares between the success rate of interscalene block and upper trunk block performed by anesthesia trainee for intra and postoperative analgesia during shoulder arthroscopy. The duration of performing the block, guidance intervention by the consultant and block failure will be recorded.

Conditions

Anesthesia, Local; Shoulder Pain

Keywords

Anesthesia, Local; Shoulder

Outcome Measures

Primary Outcomes (1)

• Success rate of upper trunk block and interscalene block

  Sensory and motor blockade will be assessed 30 minutes after block performance. Motor block will be evaluated by asking the patient to abduct his arm and will be graded on a three-points scale (2 = normal; 1 = weakness, and 0 = complete loss of power). Sensory block will be evaluated in the C4, C5, and C6 dermatomes and will be graded on a three-points scale (2 = normal; 1 = loss of sensation to pinprick; and 0 = loss of sensation to light touch). Block success will be defined as a sensory score of 0 within 30min

  30 minutes after block performance

Secondary Outcomes (6)

• Duration of performing the block

  During the procedure

• Guidance interventions

  During the procedure

• Visualization of anatomic structures

  During the procedure

• Postoperative pain

  24 hours postoperatively

• Opioid consumption

  24 hours postoperatively

Study Arms (2)

Interscalene block

ACTIVE COMPARATOR

Patients will receive inter scalene brachial plexus block combined with general anesthesia

Procedure: Interscalene brachial plexus block combined with general anesthesia

Upper trunk block

ACTIVE COMPARATOR

Patients will receive upper trunk brachial plexus block combined with general anesthesia

Procedure: Upper trunk brachial plexus block combined with general anesthesia

Interventions

Interscalene brachial plexus block combined with general anesthesia PROCEDURE

Baseline diaphragmatic assessment will be performed before the nerve block in the sitting position. Interscalene block will be done as follows. US probe will be placed slightly lower to the level of the cricoid cartilage, followed by scanning of the neck to search for C5 and C6 nerve roots enclosed between the anterior and middle scalene muscles. The needle will be introduced in-plane from lateral to medial through the middle scalene muscle until the tip enters the brachial plexus sheath between the C5 and C6 roots, where LA will be injected. Patients will be transported to the operation room where general anaesthesia will be induced with tracheal intubation Fentanyl (0.5 μg/kg) will be given to maintain the heart rate and mean blood pressure 20% lower than preinduction values. Intravenous 1 gram paracetamol and 8 mg dexamethasone will be given to all patients as part of multimodal analgesia

Interscalene block

Upper trunk brachial plexus block combined with general anesthesia PROCEDURE

Baseline diaphragmatic assessment will be performed before the nerve block in the sitting position like the the ISB group Upper trunk will be visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the departure of the suprascapular nerve (This nerve is a small hypoechoic circle that depart the lateral aspect of the upper trunk and courses posterolateral under the omohyoid muscle). The needle will be introduced in-plane from lateral to medial under the deep cervical fascia and through a very small portion of the middle scalene muscle, until the needle tip lies adjacent to the upper trunk, LA will be distributed below and above the upper trunk. Scanning for the upper trunk can be started from the supraclavicular fossa and moving proximal or opposite to cricoid cartilage and moving distal. The following steps will be done as in the ISB group

Upper trunk block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 75 years
• American Society of Anesthesiologists physical status I to III

You may not qualify if:

• Severe pulmonary disease
• Allergy to any of the study medications
• Local infection at any of the puncture sites
• Chronic gabapentin or pregabalin use
• Chronic opioid use
• Preexisting neuropathy of the operative limb, herniated cervical disc
• Body mass index more than 35 kg/m2.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, 21651, Egypt

Location

Related Publications (1)

• Abdallah FW, Halpern SH, Aoyama K, Brull R. Will the Real Benefits of Single-Shot Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. Anesth Analg. 2015 May;120(5):1114-1129. doi: 10.1213/ANE.0000000000000688.

  PMID: 25822923 RESULT

MeSH Terms

Conditions

Shoulder Pain

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Moustafa A Moustafa, MD

  Alexandria University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moustafa A Moustafa, MD

CONTACT

+201222373407; moustafa.abdelaziz@alexmed.edu.eg

Aly MM Ahmed, MD

CONTACT

+201224129850; a_ahmed00@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: July 6, 2023
• Study Start: July 15, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year
• Access Criteria: Email of principal investigator

Locations

EG (1)