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Completed

NCT Number: NCT05920421

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

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.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emad Hamdy Mohamed Morsy

Zagazig, Sharqia Province, 44519, Egypt

About this study

Ultrasound has a significant role in recent anesthesia. It plays a significant role in detecting diaphragmatic mobility and detecting phrenic nerve palsy after regional anesthesia . the common and standard technique for shoulder analgesia is interscalen block. but it has its own complications like phrenic nerve palsy.

to bypass this complications ,several ways had been tried to overcome this complications.

in this study, the investigator compare between the standard interscalen block with distal blocks like infraclavicular subomohyoid block and subomohyoid subscapularis blocks according to diaghragm affection , duration of analgesia , side effects occured with blocks.

For infraclavicular subomohyoid block, the infraclavicular approach targets the posterior and lateral cords, thus anesthetizing the axillary nerve (which supplies the anterior and posterior shoulder joint), whereas the suprascapular nerve block done by blocking subomohyoid muscle anesthetizes the posterior shoulder.

For subscapularis subomohyoid block, subscapularis is done before subomohyoid block. Subscapularis block target subscapular nerve which arise from posterior cord and present on ventral surface of subscapularis muscle .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • - 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

Treatment and study plan

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

Primary outcomes

  1. Change is being assessed (Diaphragm excursion)

    Time frame: basal preoperatively , immediately postoperatively in the pacu and 6 hours postoperatively

    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.

  2. Thickness fraction

    Time frame: basal preoperatively, immediately postoperatively in the PACU, and 6 hours postoperatively

    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.

Secondary outcomes

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

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

    The investigators ask the patient to estimate the degree of pain on a scale from 1 to 10 and ask the patient to report the degree of pain from 0 to 10, with 0 no pain to 10 worst pain.

  2. Total pethidine consumption in 24 hours of the studied groups

    Time frame: 24 hours

    The investigator will calculate the total amount of pethidine consumed over a 24-hour period.

  3. postoperative complication of the studied groups

    Time frame: 24 hours

    the investigator will record patients with complications from the blocks like hypoxemia with saturation <90% , bradycardia with heart rate <50, nausea and vomiting

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jun 27, 2023
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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