Interscalene Versus Combined Infraclavicular-suprascapular Nerve Blocks

NCT03628950 | Completed

• 1 other identifier: D165
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to compare the analgesic efficiency and hemi-diaphragmatic paralysis of the standard ultrasound-guided interscalene (ISB) brachial plexus block with the combined use of costoclavicular approach of infraclavicular brachial plexus block and suprascapular nerve block (ICB-SSB) for patients undergoing arthroscopic rotator cuff repair. Authors hypothesize that the combined use of ICB-SSB could lead to equivalent postoperative analgesic effect to the standard ISB with less hemi-diaphragmatic paralysis.

Conditions

Postoperative Pain

Keywords

Interscalene block; Postoperative analgesia; Suprascapular nerve block; Infraclavicular nerve block; Arthroscopic rotator cuff repair; Hemi-diaphragmatic paralysis

Outcome Measures

Primary Outcomes (1)

• The cumulative morphine consumption at first 24 hours postoperatively.

  in milligram

  24 hours after recovery from general anesthesia

Secondary Outcomes (38)

• Assessment of hemidiaphragmatic paralysis

  5 minutes before intervention

• Assessment of hemidiaphragmatic paralysis

  5 minutes after intervention

• Assessment of hemidiaphragmatic paralysis by abdominal ultrasound examination

  10 minutes after recovery from general anesthesia

• Assessment of postoperative pain

  1 hour after recovery from general anesthesia

• Assessment of postoperative pain

  4 hours after recovery from general anesthesia

Study Arms (2)

ICSSB group

ACTIVE COMPARATOR

infraclavicular suprascapular nerve block administered group

Procedure: ICSSB group

ISB group

ACTIVE COMPARATOR

interscalene nerve block administered group

Procedure: ISB group

Interventions

ICSSB group PROCEDURE

At supine position with abducted limb, the probe of ultrasound will be translocated in costoclavicular space; the subclavian artery will be identified. The three cords of the brachial plexus will be visualized lateral to the artery. By using an in-plane technique and a cephalad-to-caudate direction, the block needle will be advanced until its tip will be in the middle of three cords and 10 mL of 0.25 % bupivacaine Hydrochloride will be injected. Then at lateral decubitus position, by using in-plane technique the probe will be translocated in suprascapular fossa, lateral-to-medial direction, the block needle will be advanced until its tip in the floor of the suprascapular fossa ventral to the fascia of the supraspinatus muscle and 10 mL of 0.25 % bupivacaine Hydrochloride will be injected .

Also known as: Infraclavicular suprascapular block group

ICSSB group

ISB group PROCEDURE

The probe of ultrasound will be applied in lateral side of the neck at the level of the cricoid cartilage to obtain a view of the three hypoechoic structures which represent the roots of the brachial plexus. Using an in-plane technique and a lateral to-medial direction, the block needle will be advanced until its tip will be positioned under the prevertebral fascia between the two most superficial hypoechoic structures and 10 mL of 0.25 % bupivacaine Hydrochloride will be injected at level of C5-6 and another 10 ml of 0.25 % bupivacaine Hydrochloride will be injected at level of C7-8.

Also known as: Interscalene group

ISB group

Eligibility Criteria

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

You may qualify if:

• American Society association (ASA) physical status I to III patients who will be scheduled for an elective arthroscopic rotator cuff repair.

You may not qualify if:

• Patient refusal
• preexisting (obstructive or restrictive) pulmonary disease or low baseline oxygen saturation
• contraindication to regional anesthesia (coagulopathy, allergy to local anesthetic, sever thrombocytopenia, pre-existing neuropathy in operative limb, infection at puncture site).
• sepsis
• hepatic or renal dysfunction.
• Advanced cardiovascular diseases
• chronic pain condition requiring the intake of opioids at home.
• prior surgery in the neck or infraclavicular/suprascapular fossa.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

Related Publications (5)

• Ullah H, Samad K, Khan FA. Continuous interscalene brachial plexus block versus parenteral analgesia for postoperative pain relief after major shoulder surgery. Cochrane Database Syst Rev. 2014 Feb 4;2014(2):CD007080. doi: 10.1002/14651858.CD007080.pub2.

  PMID: 24492959 BACKGROUND

• Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.

  PMID: 2006740 BACKGROUND

• Aliste J, Bravo D, Finlayson RJ, Tran DQ. A randomized comparison between interscalene and combined infraclavicular-suprascapular blocks for arthroscopic shoulder surgery. Can J Anaesth. 2018 Mar;65(3):280-287. doi: 10.1007/s12630-017-1048-0. Epub 2017 Dec 19.

  PMID: 29270914 BACKGROUND

• Tran DQ, Elgueta MF, Aliste J, Finlayson RJ. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):32-38. doi: 10.1097/AAP.0000000000000529.

  PMID: 27941477 BACKGROUND

• Karmakar MK, Sala-Blanch X, Songthamwat B, Tsui BC. Benefits of the costoclavicular space for ultrasound-guided infraclavicular brachial plexus block: description of a costoclavicular approach. Reg Anesth Pain Med. 2015 May-Jun;40(3):287-8. doi: 10.1097/AAP.0000000000000232. No abstract available.

  PMID: 25899958 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Safaa G Ragab, MD

  Faculty of medicine, Fayoum university

  STUDY DIRECTOR

• Mohamed M Arafa, MD

  Faculty of medicine, Fayoum university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: July 21, 2018
• First Posted: August 14, 2018
• Study Start: September 1, 2018
• Primary Completion: August 31, 2020
• Study Completion: September 30, 2020
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)