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Not yet recruiting NCT07338630

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

No phase Interventional Diaphragm Issues

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Regional anesthesia in shoulder surgery.
Who it may be relevant to
Registry conditions: Diaphragm Issues. Basic parameters: 20 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Phrenic Nerve Sparing of the Interscalene Block Alone Versus Combined With Superior Truncus Block During Shoulder Surgery , Prospective Comparative Randomized Study

Overview

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.

Detailed description

Regional anesthesia is central to modern shoulder surgery because it provides excellent perioperative analgesia, reduces opioid consumption, and facilitates early rehabilitation. The interscalene brachial plexus block (ISB) has long been considered the gold-standard single-shot regional technique for shoulder procedures due to its reliable analgesia and surgical anesthesia. However, ISB commonly causes ipsilateral hemidiaphragmatic paresis (HDP) from unintended phrenic nerve blockade, which can produce clinically important declines in pulmonary function and may be poorly tolerated in patients with limited respiratory reserve.

To minimize phrenic involvement while preserving analgesic effectiveness, more selective approaches have been proposed. The superior trunk block (STB) - performed at the level where C5-C6 fibers form the superior trunk - aims to anesthetize the shoulder innervation more distally and thus reduce spread to the phrenic nerve. A landmark randomized trial and subsequent studies reported that STB provides analgesia comparable to ISB while greatly lowering the incidence of HDP (for example, ISB 71% vs STB 5% in one trial). Systematic reviews and meta-analyses since then have reinforced STB as an effective phrenic-sparing alternative for many shoulder procedures.

Despite encouraging data for STB, the literature is not entirely uniform. Some randomized trials and observational reports have found either reduced anesthetic quality with STB or smaller-than-expected reductions in phrenic involvement, particularly when block technique, local anesthetic volume, or patient anatomy differ. Moreover, combining blocks (for example, ISB with selective superior-trunk targeting or other modifications) has been proposed as a strategy to balance surgical anesthesia and respiratory safety, but comparative prospective data examining the effect of ISB alone versus ISB combined with STB on diaphragmatic function are limited. This uncertainty is important because even partial diaphragmatic paresis can degrade postoperative pulmonary mechanics and increase complications in vulnerable patients.

Interventions

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

Primary outcome measures

  • Comparison between interscalene block alone versus combined with superior truncus block inproducing diaphragmatic paralysis [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 outcome measures (4)
  • Evaluation of the interscalene block alone versus combined with superior truncus block during shoulder surgery on the pulmonary function [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]
  • Duration of the sensory and motor block onset, duration of the interscalene block alone versus combined with superior truncus block during shoulder surgery [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]
  • Evaluation of postoperative analgesic consumption [Time frame: 12 hours]
  • Evaluation of any complications or side effects during shoulder surgery [Time frame: 24 hours]

Eligibility criteria

Inclusion criteria

  • 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.
  • Scheduled for shoulder surgery.

Exclusion criteria

  • Allergy to local anesthetics.
  • Infection at the injection site.
  • Coagulation disorders.
  • Respiratory diseases ( Acute or Chronic) or Chest trauma.
  • Multiple traumatized patients.
  • Phrenic nerve injury
  • Heart failure, Cardiomyopathy.
  • Severe organ dysfunction
  • Patient refusal

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07338630 · Soh-Med--25-11-5MD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗