Clinical trial NCT05920421: Diaphragm Sparing Effect of Subomohyoid Block With Infraclavicular or Subscapularis Blocks in Comparison With Interscalen Block for Postoperative Analgesia in Shoulder Surgeries
Official title: Diaphragm Sparing Effect of Subomohyoid Block With Infraclavicular or Subscapularis Blocks in Comparison With Interscalen Block for Postoperative Analgesia in Shoulder Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Surgeries Operations
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-06-27
Enrollment: 69
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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 .

Eligibility criteria: 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

Primary outcomes:
measure: Change is being assessed (Diaphragm excursion)
timeFrame: basal preoperatively , immediately postoperatively in the pacu and 6 hours postoperatively
Secondary outcomes:
measure: Onset time of sensory block
timeFrame: 30 minutes after local anesthetic injection
measure: Visual Analogue Scale (VAS) at different intervals within and between the studied groups
timeFrame: immediately postoperative in the PACU , 6 hours postoperatively up to 24 hour postoperatively
measure: Duration of analgesia and total pethidine consumption in 24 hours of the studied groups
timeFrame: 24 hours
measure: postoperative complication of the studied groups
timeFrame: 24 hours
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Emad Hamdy Mohamed Morsy
state: Sharqia
Study officials:
References:
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