- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07688395
Erector Spinae Plane Block Versus Infraspinatus-Teres Minor Interfascial Plane Block for Analgesia After Shoulder Arthroscopy
Novel Analgesic Approaches in Shoulder Surgery: Erector Spinae Plane Block Versus Infraspinatus-Teres Minor Interfascial Plane Block
The shoulder, being an anatomical region innervated by different nerves, has a wide variety of analgesic approaches, which differ depending on the practitioner. New approaches are being developed based on the different innervation channels demonstrated in clinical and cadaver studies. Over time, the effectiveness of axillary block, suprascapular block, interscalene block, local infiltration, and various combinations, as well as non-regional methods, has been observed. The goal of these approaches is to achieve the highest possible level of patient comfort, high analgesic efficacy, and minimal complications. Studies have shown that the interscalene block has the highest analgesic efficacy and the most ideal postoperative results; therefore, it is frequently used as the gold standard in this field. Providing effective analgesia with a single intervention can also be cited as an aspect that increases patient comfort and simplifies the procedure. In interscalene block; unilateral transient diaphragmatic paralysis due to the spread of local anesthetics to the C7 nerve root, respiratory problems and potential spinal/epidural complications, new approaches are being followed and researched. Results from cervical/high thoracic erector spinae plane block (ESPB) and infraspinatus-teres minor interfascial plane block (ITMIPB) studies, which are the subject of new studies, strengthen the hypothesis that they provide effective analgesia. Neither of these blocks, performed with ultrasonography, carries the risks present in interscalene block. Although the usual risks of a peripheral nerve block are present for these procedures; the block sites are considered safer due to its distance from vascular structures and the reduced risk of additional complications. While small sample studies exist for each type of block, no studies comparing their effectiveness have been found. Besides reduced complications, another advantage of these two blocks is their ability to provide effective analgesia with a single-point injection. The aim of this study is to compare the analgesic efficacy of Cervical Erector Spine Plane Block (ESP) and Infraspinatus-Teres Minor Interfascial Plane Block (ITMIPB) applied for postoperative analgesia in ASA I-III patients undergoing shoulder surgery.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Canberk Çetinel, MD
- Telefonnummer: +905396996239
- E-mail: canberkc@gmail.com
Studiesteder
-
-
Beyoğlu
-
Istanbul, Beyoğlu, Tyrkiet (Türkiye), 34433
- Taksim Educational and Research Hospital
-
Kontakt:
- Canberk Çetinel, MD
- Telefonnummer: +905396996239
- E-mail: canberkc@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adults scheduled for elective shoulder arthroscopy
- ASA I-II-III patients
- Patients age between 18-80
Exclusion Criteria:
- Patients with previously known allergy to local anesthetics.
- Patients with insufficient pulmonary functions (Severe obstruction or restriction in Pulmonary Function Test)
- Patients with ASA IV or higher
- Patients who suffered from any complications related to anesthesia or surgery
- Patients with additional body part injury
- Pregnant or breastfeeding women
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Erector Spinae Plane Block Group
Patients receiving ultrasound-guided cervical erector spinae plane block for postoperative analgesia. |
Before shoulder surgery, Ultrasound-guided C8-T1 ESP block will be performed for postoperative analgesia In the both groups, peripheral nerve blocks are performed by using Bupivacaine %0,25. |
|
Aktiv komparator: Infraspinatus Teres Minor Interfascial Plane Block Group
Patients receiving ultrasound-guided Infraspinatus Teres Minor Interfascial Plane Block for postoperative analgesia. |
In the both groups, peripheral nerve blocks are performed by using Bupivacaine %0,25. Before surgery, Ultrasound-guided Infraspinatus Teres Minor Interfascial Plane Block will be performed for postoperative analgesia |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative pain intensity
Tidsramme: Postoperative 1., 6., 12. and 24. hour
|
Pain intensity assessed using the 11-point Numeric Rating Scale (NRS; 0=no pain, 10=worst imaginable pain). |
Postoperative 1., 6., 12. and 24. hour
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total postoperative analgesic consumption
Tidsramme: 24 hours after surgery
|
Total amount of rescue analgesics (NSAIDs, paracetamol, and opioids) administered during the first 24 hours after surgery. Opioid consumption will be converted to intravenous morphine equivalents for analysis, when applicable. |
24 hours after surgery
|
|
Incidence of postoperative nausea and vomiting (PONV)
Tidsramme: 24 hours after surgery
|
Occurrence of postoperative nausea and/or vomiting requiring treatment during the first 24 hours after surgery. Also, the need for rescue antiemetic medication will be recorded. |
24 hours after surgery
|
|
Block-related complications
Tidsramme: 24 hours after surgery
|
Incidence of block-related complications, including local anesthetic systemic toxicity, vascular puncture, hematoma, infection, pneumothorax, persistent sensory or motor deficits, and other procedure-related adverse events. |
24 hours after surgery
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Desai N. Postoperative analgesia for shoulder surgery. Br J Hosp Med (Lond). 2017 Sep 2;78(9):511-515. doi: 10.12968/hmed.2017.78.9.511.
- Eckmann MS, Bickelhaupt B, Fehl J, Benfield JA, Curley J, Rahimi O, Nagpal AS. Cadaveric Study of the Articular Branches of the Shoulder Joint. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):564-570. doi: 10.1097/AAP.0000000000000652.
- Kapukaya F, Ekinci M, Ciftci B, Atalay YO, Golboyu BE, Kuyucu E, Demiraran Y. Erector spinae plane block vs interscalene brachial plexus block for postoperative analgesia management in patients who underwent shoulder arthroscopy. BMC Anesthesiol. 2022 May 12;22(1):142. doi: 10.1186/s12871-022-01687-5.
- Ahiskalioglu A, Karapinar YE, Dagci Y, Yayik AM, Ciftci B, Tulgar S. An alternative sonographic approach to infraspinatus-teres minor interfascial plane block: make it easy. Minerva Anestesiol. 2025 Apr;91(4):359-361. doi: 10.23736/S0375-9393.24.18697-X. Epub 2025 Feb 6. No abstract available.
- Ma D, Wang R, Wen H, Li H, Jiang J. Cervical erector spinae plane block as a perioperative analgesia method for shoulder arthroscopy: a case series. J Anesth. 2021 Jun;35(3):446-450. doi: 10.1007/s00540-021-02907-x. Epub 2021 Mar 8.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2024-KAEK-12
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-delingstidsramme
Beginning 6 months following publication and ending 5 years after publication.
IPD-delingsadgangskriterier
Individual participant data will be available to qualified researchers upon reasonable request to the principal investigator. Requests will be evaluated based on scientific merit and ethical considerations.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
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