Onset and Recovery of Ultrasound Guided Out-of-plane Versus In-plane Interscalene Block in Arthroscopic Shoulder Surgery

NCT05381389 | Completed

• 1 other identifier: FMASU R59/2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to assess the out-of-plane versus the in-plane approaches for the interscalene brachial plexus block; as regards the performance time, the onset, the progression and the recovery of sensory block, the onset and progression of the motor block as well as, the postoperative pain score and the duration of analgesia for arthroscopic shoulder surgery. A total of 60 patients of American Society of Anesthesiologists (ASA) physical status I-II were randomly divided to receive either the in-plane approach (Group I), or the out-of-plane approach (Group O).

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• The onset of sensory block (time to C5 block)

  defined as the period between the completion of the LA administration and the loss of sensation to pin prick in C5 dermatome performed every 1 minute

  30 minutes

Secondary Outcomes (7)

• The procedure time

  20 minutes

• Progression of sensory block

  over the first 20 minutes of LA injection

• The onset of motor block

  30 minutes

• The progression of motor block

  over the first 20 minutes of LA injection

• The duration of motor block

  24 hours

Study Arms (2)

Group In-plane approach:

ACTIVE COMPARATOR

An in-plane approach was used for the interscalene block. The needle was brought in the same plane as the probe at a shallow angle to the skin, some distance away from the edge of the probe in a lateral to medial direction so that the whole length of the needle can be visualized. After negative aspiration and assurance that high resistance to injection was absent, the LA was injected in a 5 ml increment below the lower root, between the 3 roots and above the upper root.

Drug: Bupivacaine Hydrochloride in-plane approach for the interscalene block

Group Out-of-plane approach

ACTIVE COMPARATOR

An out-of-plane approach was used for the interscalene block. The needle was inserted cranial to the probe and after negative aspiration and assurance that high resistance to injection was absent, the LA was injected in a 10 ml increment; lateral and medial to the nerve roots. The needle appeared as a bright dot on the screen and by tilting the probe, the tip was identified as the point where further tilting leads to no longer visualization of the bright dot on the screen.

Drug: Bupivacaine Hydrochloride out of-plane approach for the interscalene block

Interventions

Bupivacaine Hydrochloride in-plane approach for the interscalene block DRUG

20 ml of 0.5% bupivacaine added to them 50 μg adrenaline in a concentration of 1:400,000, were prepared by an assistant immediately before administration and injected in an in-plane approach to the brachial plexues

Group In-plane approach:

Bupivacaine Hydrochloride out of-plane approach for the interscalene block DRUG

20 ml of 0.5% bupivacaine added to them 50 μg adrenaline in a concentration of 1:400,000, were prepared by an assistant immediately before administration and injected in an out of-plane approach to the brachial plexues

Group Out-of-plane approach

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I - II
• scheduled to undergo arthroscopic shoulder surgery in the lateral position

You may not qualify if:

• body mass index ≥ 35 kg/m2 body surface area
• anticipated difficult airway
• infection at the injection site
• known LA allergy,
• contralateral phrenic nerve dysfunction
• history of cardiac disease
• history of hepatic disease
• history of renal disease
• coagulopathy
• chronic obstructive pulmonary disease
• neuropathy involving the brachial plexus.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 19, 2022
• Study Start: December 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)