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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06396455
Other study ID # RC 16-1-2024
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 26, 2023
Est. completion date April 4, 2024

Study information

Verified date April 2024
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Diaphragmatic dysfunction can be detected as a decrease in forced vital capacity (FVC) and forced expiratory volume at 1 s (FEV1) on spirometry or as lower diaphragmatic excursion (DE) on US, the latter having become the gold standard in thoracic assessment.


Description:

Severe intraoperative and postoperative pain associated with arthroscopic shoulder surgery has high incidence reaching up to 45%; it is often significant enough to interfere with initial recovery and rehabilitation. Shoulder arthroscopy is becoming more common, representing the second most common Orthopedic surgery after knee arthroscopy . Interscalene brachial plexus block (ISB) is the gold standard analgesic technique for shoulder surgeries with success rates of 87% to 100%, but it also blocks the phrenic nerve (C3-C5). Suprascapular nerve block via the anterior approach (SSB-A) is performed distally at the trunk/division level of the brachial plexus, thereby potentially sparing the phrenic nerve and minimising many adverse effects of ISB


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 4, 2024
Est. primary completion date March 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - aged (18-65 years) - American Society of Anesthesiologists (ASA) physical status I or II - scheduled for elective arthroscopic shoulder surgery Exclusion Criteria: - pre-existing respiratory, - cardiac, renal, neurological, or hepatic disease, neuropathy affecting brachial plexus - contraindication to peripheral nerve block (e.g., coagulopathy),

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
interscalene block group
The ISB group scanning was done by linear ultrasound probe just below the level of the cricoid cartilage medial to the sternocleidomastoid muscle; the skin was disinfected, and the transducer was positioned in the transverse plane to identify the carotid artery. Once the artery was identified, the transducer was moved slightly laterally across the neck to identify the scalene muscles and the brachial plexus that is present between the anterior and middle scalene muscles. 3 ml lidocaine 1% was injected at puncture site The needle was then inserted in-plane toward the brachial plexus, in a lateral-to-medial direction. After a careful aspiration, 20 ml of bupivacaine 0.25% was injected.
Suprascapular nerve block group
After cleaning the skin with an antiseptic solution, an ultrasound probe was put in sagittal orientation at the superior medial border of the scapula to identify the pleura and then moved laterally; when it was parallel to the spine of the scapula, the transducer was moved cephalad and the suprascapular fossa was identified, and then the transducer was moved lateral to locate the suprascapular notch. The suprascapular nerve was a round hyperechoic structure beneath the transverse scapular ligament in the scapular notch. 3 ml lidocaine 1% was injected at puncture site then the needle was inserted along the longitudinal axis of the ultrasound beam, and 10 ml of bupivacaine 0.25% was injected.

Locations

Country Name City State
Egypt Benha University Banha

Sponsors (1)

Lead Sponsor Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary visual analogue score The visual analogue score (VAS) was used (0 indicating no pain and 10 indicating worst unbearable pain) at rest and upon flexion for assessment of pain intensity upon arrival to the PACU Postoperative pain was assessed using VAS at Postoperative care unit, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24hours after block administration postoperatively
Secondary Patient satisfaction Patient satisfaction was evaluated using 5-point Likert scale) (1=extremely dissatisfied; 5=extremely satisfied) 24 hours postoperatively
See also
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