Diaphragm Sparing Effect of Subomohyoid Block With Infraclavicular or Subscapularis Blocks in Comparison With Interscalen Block for Postoperative Analgesia in Shoulder Surgeries

NCT05920421 | Completed

• 1 other identifier: #6024/5-4-2022
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

The gold standard for shoulder analgesia is the interscalene block (ISB), but it has its own share of disadvantages such as phrenic nerve block, recurrent laryngeal nerve involvement and Horner's syndrome may lead to patient discomfort .Others, such as intrathecal spread and systemic toxicity of local anesthetic, can have serious consequences. Phrenic nerve injury is a common complication with regional anesthesia. Its either temporary with Transient Phrenic Nerve Palsy leading to hemidiaphragmatic paresis after interscalene block or other injections of local anesthetic in the neck . Although studies of ISB have shown a reduction in the incidence in hemidiaphragmatic paralysis with low-volume ISB, the risk of phrenic paralysis is not completely eliminated. To bypass this complication, distal block of the shoulder innervation is recommended such as subomohyoid infraclavicular and subomohyoid subscapularis blocks.

Conditions

Shoulder Surgeries Operations

Outcome Measures

Primary Outcomes (2)

• Change is being assessed (Diaphragm excursion)

  As shown before diaphragm excursion will be examined preoperative as basal measurement, immediately postoperative in the PACU and 6 hours postoperatively to detect diaghragm excursion.If ratio of post to pre-block is \< 25% this means that phrenic nerve block is included.

  basal preoperatively , immediately postoperatively in the pacu and 6 hours postoperatively

• Thickness fraction

  The percentage change in thickness between end expiration and peak inspiration. It was calculated as follows: (thickness at peak inspiration - thickness at end expiration/thickness at end expiration) ×100.

  basal preoperatively, immediately postoperatively in the PACU, and 6 hours postoperatively

Secondary Outcomes (3)

• Visual Analogue Scale (VAS) at different intervals within and between the studied groups

  immediately postoperative in the PACU , 6 hours postoperatively up to 24 hour postoperatively

• Total pethidine consumption in 24 hours of the studied groups

  24 hours

• postoperative complication of the studied groups

  24 hours

Study Arms (3)

interscalen group

PLACEBO COMPARATOR

(29) patients will receive an interscalene block before induction of general anaesthesia. Patients will receive 20 ml of bupivacaine 0.25 %+250 mg of magnesium sulphate.

Procedure: diaghragm affection by ultrasound before and after the blocks

subomohyoid infracavicular group

ACTIVE COMPARATOR

(29) patients will receive subomohyoid infraclavicular block before induction of general anesthesia. Patients will receive 20 ml of bupivacaine 0.25 %+250 mg of magnesium sulphate.

Procedure: diaghragm affection by ultrasound before and after the blocks

subomohyoid subscapularis group

ACTIVE COMPARATOR

(29) patients will receive subomohyoid subscapularis block before induction of general anesthesia. Patients will receive 20 mL of 0.25% bupivacaine + 250 mg of magnesium sulfate.

Procedure: diaghragm affection by ultrasound before and after the blocks

Interventions

diaghragm affection by ultrasound before and after the blocks PROCEDURE

the participant will assess diaphragm sparing in each block and evaluate effectiveness of infraclavicular subomohyoid blocks and subomohyoid subscapularis blocks according to intraoperative and postoperative analgesia and diaphragm affection and comparing them with interscalen and with each others

interscalen group; subomohyoid infracavicular group; subomohyoid subscapularis group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient acceptance.
• ASA I and ASA II.
• Age 21-60 years old.
• Both gender.
• BMI \< 35 Kg/m2.
• Accepted mental state of the patient.
• Elective Unilateral upper limb surgeries at the level of the shoulder.
• Time of surgery less than 2 hours

You may not qualify if:

• \- Patient refusal.
• Peripheral neuropathy.
• Pathological coagulopathy.
• Infection at the injection site.
• Untreated pneumothorax.
• Disturbed conscious level.
• An allergy to local anesthetics used in this study

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Emad Hamdy Mohamed Morsy

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Publications (8)

• Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Nerve Block for Analgesia in Arthroscopic Shoulder Surgery: An Equivalence Study. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):564-71. doi: 10.1097/AAP.0000000000000436.

  PMID: 27380105 BACKGROUND

• Battaglia PJ, Haun DW, Dooley K, Kettner NW. Sonographic measurement of the normal suprascapular nerve and omohyoid muscle. Man Ther. 2014 Apr;19(2):165-8. doi: 10.1016/j.math.2013.12.005. Epub 2013 Dec 27.

  PMID: 24412231 BACKGROUND

• Musso D, Flohr-Madsen S, Meknas K, Wilsgaard T, Ytrebo LM, Klaastad O. A novel combination of peripheral nerve blocks for arthroscopic shoulder surgery. Acta Anaesthesiol Scand. 2017 Oct;61(9):1192-1202. doi: 10.1111/aas.12948. Epub 2017 Aug 4.

  PMID: 28776638 BACKGROUND

• Bergmann L, Martini S, Kesselmeier M, Armbruster W, Notheisen T, Adamzik M, Eichholz R. Phrenic nerve block caused by interscalene brachial plexus block: breathing effects of different sites of injection. BMC Anesthesiol. 2016 Jul 29;16(1):45. doi: 10.1186/s12871-016-0218-x.

  PMID: 27473162 BACKGROUND

• Panero AJ, Hirahara AM. A Guide to Ultrasound of the Shoulder, Part 2: The Diagnostic Evaluation. Am J Orthop (Belle Mead NJ). 2016 May-Jun;45(4):233-8.

  PMID: 27327915 BACKGROUND

• Boon AJ, O'Gorman C. Ultrasound in the Assessment of Respiration. J Clin Neurophysiol. 2016 Apr;33(2):112-9. doi: 10.1097/WNP.0000000000000240.

  PMID: 27035251 BACKGROUND

• Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.

  PMID: 14622683 BACKGROUND

• Aszmann OC, Dellon AL, Birely BT, McFarland EG. Innervation of the human shoulder joint and its implications for surgery. Clin Orthop Relat Res. 1996 Sep;(330):202-7. doi: 10.1097/00003086-199609000-00027.

  PMID: 8804294 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of anethesia and surgical intensive care

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: June 27, 2023
• Study Start: July 20, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 30, 2024
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after puplication of the study
• Access Criteria: contact of principal investigator

Locations

EG (1)