ClinicalTrials.gg
RecruitingNCT07553611Updated May 11, 2026

The Effects of Regional Anaesthesia Techniques on Hemidiaphragm Paralysis, Postoperative Recovery Quality, Opioid Consumption, and Pain Scores

An observational study in Regional Anaesthesia, Arthroscopic Shoulder Surgery and Hemidiaphragmatic Paralysis, sponsored by Antalya Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Antalya Training and Research Hospital · Observational

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
88
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study aims to evaluate the effects of ultrasound-guided interscalene, erector spinae plane, costoclavicular, and supraclavicular blocks on hemidiaphragmatic paralysis, postoperative recovery quality, opioid consumption, and pain scores.

Read the detailed description

Arthroscopic shoulder surgery is a significant approach to diagnosing and treating rotator cuff tears, impingement syndrome, instability, SLAP and Bankart injuries, and other shoulder disorders. Applications of this technique have become increasingly popular in recent yeras. Howeveri although arthroscopic sholuder surgery is conderered minimally invasive, it has been reported to cause moderate to severe postoperative pain, which can hinder patient recovery and rehabilitation, and potentially even extend the hospital stay. Therefore, providing an effective postoperative analgesia strategy in these patients is critical for patient comfort, mobilization, and overall recovery. Various methods are employed to managepostoperative pain in patients undergoing arthroscopic shoulder surgery, with regional techniques being the most prevalent. These regional techniques provide both intraoperative and postoperative analgesia in shoulder surgeries. The aim of this study is to evaluate the effects of ultrasound-guided four block techniques on hemidiaphragmatic paralysis, postoperative recovery quality, opioid consumption, and pain scores.

02

Conditions studied

  • Regional Anaesthesia
  • Arthroscopic Shoulder Surgery
  • Hemidiaphragmatic Paralysis
  • Recovery Quality
  • Opioid Consumption
  • Postoperative Pain Score

Keywords

  • regional anaesthesia
  • arthroscopic shoulder surgery
  • hemidiaphragmatic paralysis
  • recovery quality
  • opioid consumption
  • postoperative pain score
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 88 is below the median of 102 across 683 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Antalya Training and Research Hospital is the lead sponsor of 104 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

It is planned to include ASA score I-III, aged 18-65 years, who are planned to undergo elective arthroscopic surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • aged 18-65 years
  • American Society of Anaesthesiology (ASA) score I-III
  • (BMI) \<30kg/m2
  • scheduled for elective arthroscopic surgery

Exclusion criteria

Exclusion Criteria:

  • ≥4
  • ≥30 kg/m2
  • declining to give written
  • controendications for block application
  • history of mental or neurological disease, severe liver and/or kidney disease
  • history of moderate or severe pulmonary disease
  • abnormal preoperative chest X-ray findings
  • scheduled for emergency surgery
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
88 participants (estimated)
Patient registry
No

Groups and cohorts

  • İnterscalene group

    Before the surgery, ultrasoud-guided interscalene block will be performed

    Other: İnterscalene block group

  • Erector spinae plane block group

    Before the surgery, ultrasoud-guided erector spinae plane block will be performed

    Other: Erector spinae plane block group

  • Costoclavicular block group

    Before the surgery, ultrasoud-guided costoclavicular block will be performed

    Other: Costoclavicular block group

  • Supraclavicular block group

    Before the surgery, ultrasoud-guided supraclavicular block will be performed

    Other: Supraclavivular block group

Interventions

  • Otherİnterscalene block group

    Before the surgery, ultrasoud-guided interscalene block will be performed before the surgery under standart anaesthesia monitoring

  • OtherErector spinae plane block group

    Before the surgery, ultrasoud-guided erector spinae plane block will be performed before the surgery under standart anaesthesia monitoring

  • OtherCostoclavicular block group

    Before the surgery, ultrasoud-guided costoclavicular block will be performed before the surgery under standart anaesthesia monitoring

  • OtherSupraclavivular block group

    Before the surgery, ultrasoud-guided supraclavivular block will be performed before the surgery under standart anaesthesia monitoring

06

What researchers measure

Primary outcomes

  1. Hemidiaphragmatic paralysis

    Diaghragmatic excursion will be assessed using a real-time M-mode ultrasound during quite breathing, deep breathing, and sniffing maneuvers (deep breathing through the nose)

    Time frame: 30 minutes

Secondary outcomes

  1. Recovery quality

    The postoperative recovery of patients will be assessed using the 15-item Quality of Recovery (QOR-15) score. The QOR-15 is an 15-item assessment scale that evaluates patients' pain, physical comfort, physical independence, psychological support and emotional state in early postoperative period.

    Time frame: 5 minutes

  2. Postoperative analgesic consumption

    All patients will receive a standard patient analgesia (PCA) protocol. The postoperative opioid consumption will only be recorded

    Time frame: 24 hours

  3. Postoperative pain intensity

    The postoperative pain intensity will be assessed with the Numerical Rating Scale (NRS) score (0=no pain; 10=most severe pain)

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
  • University of Health Sciences, Antalya Training and Research Hospital
    Antalya, Muratpaşa, Turkey (Türkiye)
    Recruiting
08

References and documents

Publications

  • Shagufta N, Nishant S, Rajnish K, Adil A. Hemidiaphragmatic paralysis following costoclavicular versus supraclavicular brachial plexus block: A systematic review and meta-analysis. J Anaesthesiol Clin Pharmacol. 2025 Oct-Dec;41(4):587-599. doi: 10.4103/joacp.joacp_415_24. Epub 2025 Jul 9. PubMed 41181256 ↗
  • Kim DH, Lin Y, Beathe JC, Liu J, Oxendine JA, Haskins SC, Ho MC, Wetmore DS, Allen AA, Wilson L, Garnett C, Memtsoudis SG. Superior Trunk Block: A Phrenic-sparing Alternative to the Interscalene Block: A Randomized Controlled Trial. Anesthesiology. 2019 Sep;131(3):521-533. doi: 10.1097/ALN.0000000000002841. PubMed 31283740 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Oct 2026, 6 months after the start.

Of 391 non-industry observational studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 6 months is below that.

Counting every sponsor, half of 395 studies reached it within 13 months; a quarter within 5 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2026
First posted
Apr 28, 2026
StartActual
Apr 21, 2026
Primary completionEst.
Oct 21, 2026
CompletionEst.
Nov 21, 2026
Last update
May 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07553611
Responsible party
Sponsor
First posted
Apr 28, 2026
Start date
Apr 21, 2026
Primary completion
Oct 21, 2026 (estimated)
Completion
Nov 21, 2026 (estimated)
Last update
May 11, 2026

Study contacts

Arzu Karaveli
Contact
arzukaraveli@hotmail.com
+905325611300
Bayram Akdag
Contact
bayramakdag6507@gmail.com
+905427688949
Arzu Karaveli
principal investigator · University of Health Sciences, Antalya Training and Research Hospital
Bayram Akdag
principal investigator · University of Health Sciences, Antalya Training and Research Hospital
Fatih Duygun
principal investigator · University of Health Sciences, Antalya Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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