Comparison of the Interscalene Block Alone Versus Combined With Superior Truncus Block During Shoulder Surgery in Diaphragmatic Function

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorSohag University

About this trial

Primarily, This study aims to compare between interscalene block alone versus combined with superior truncus block in producing diaphragmatic paralysis and Secondarily aims to evaluate

1. Effect on the pulmonary function. 2. Duration of the sensory and motor block. 3. Postoperative analgesic consumption. 4. Any complications or side effects during shoulder surgery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

ASA (American Society of Anesthesiologists) I, II physical status.

Aged between 20 and 65 years.

Male or female.

Body Mass index (BMI): 18-30 kg/m3.

Disqualifiers

Allergy to local anesthetics.

Infection at the injection site.

Coagulation disorders.

Respiratory diseases ( Acute or Chronic) or Chest trauma.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Regional anesthesia in shoulder surgery

    Other intervention

    Comparison of the interscalene block alone versus combined with superior truncus block during shoulder surgery in diaphragmatic function

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Interscalene block aloneActive comparator 1 intervention
Group B: Interscalene block plus Superior truncus blockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Comparison between interscalene block alone versus combined with superior truncus block inproducing diaphragmatic paralysis

Assessment of diaphragmatic function by diaphragm excursion (DE) and diaphragm thickening fraction (TF) will be measured both before and 30 minutes post-block. To measure DE, patients will be placed in a supine position, a convex transducer (3.5 \~ 5 MHz) will be used to scan while the right diaphragm through the hepatic window and the left diaphragm through the splenic window, which located near the anterior-axillary line. The craniocaudal movement of the diaphragm will be documented during deep inspiration using M-mode. * Complete diaphragmatic paralysis was defined as a 75% \~ 100% reduction in DE, including the occurrence of paradoxical movement. * Partial diaphragmatic paralysis was defined as a 25% \~ 75% reduction in DE. * No diaphragmatic paralysis was indicated by a DE reduction of less than 25%. To measure TF, patients will be placed in the same position with the head of the bed at 45°degree

Time frame
Assessment of diaphragmatic function by diaphragm excursion (DE) and diaphragm thickening fraction (TF) will be measured both before and 30 minutes post-block.

Secondary outcomes

1

Evaluation of the interscalene block alone versus combined with superior truncus block during shoulder surgery on the pulmonary function

Assessment of pulmonary function by a handheld spirometer to measure forced vital capacity (FVC), forced expiratory volume ( FEV1, FEV2) with patients in an upright-seated position pre-block and 30 minutes post-block as well as 2-hours post-surgery. Spirometry will be performed three times, with the best effort recorded.

Time frame
Assessment of pulmonary function by a handheld spirometer to measure forced vital capacity (FVC), forced expiratory volume ( FEV1, FEV2) with patients in an upright-seated position pre-block and 30 minutes post-block as well as 2-hours post-surgery
2

Duration of the sensory and motor block onset, duration of the interscalene block alone versus combined with superior truncus block during shoulder surgery

Sensory block onset time will be assessed at the time from local anesthetics injection by pinprick test which will be preformed with 22-gauge short beveled needle every minute. Sensory block recovery time will be noted every hour in 1st 6 hours, every 2 hours in 2nd 6 hours till recovery of all pain sensation in all dermatomes performed by pinprick test. Motor block onset time will be assessed at the time from local anesthetics injection until complete motor block which will be assessed by absence of voluntary movement on asking the patient to elevate his arm every minute. Motor block recovery time will be noted as the time of return of voluntary movement in the arm every hour in 1st 6 hours, every 2 hours in 2nd 6 hours.

Time frame
Sensory, motor block onset time every minute. Sensory, Motor block duration every hour in 1st 6 hours , every 2 hours in 2nd 6 hours
3

Evaluation of postoperative analgesic consumption

Pain will be evaluated Postoperative immediately every hour in 1st 6 hours, every 2 hours in 2nd 6 hours by Visual Analogue Scale ( VAS) by instructing the patient to point to the position on the line to indicate how much pain they are currently feeling(10). * VAS (zero) indicates no pain. * VAS ( 1, 2, 3) indicates mild pain. * VAS ( 4, 5, 6) indicates moderate pain. * VAS ( 7, 8, 9, 10) : indicates severe pain.

Time frame
12 hours
4

Evaluation of any complications or side effects during shoulder surgery

Any local or systemic complications or side effects will be recorded every 2 hours post operative for 24 hours such as local anesthetic systemic toxicity (LAST), Horner's syndrome, hypoxia, dyspnea, pneumothorax and post-operative nausea and vomiting (PONV).

Time frame
24 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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