- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07823920
The Clinical Impact of Serratus Anterior VS. Erector Spinae Plane Block on Pain Management of Tube Thoracostomy in Emergency Department Patients.
11. september 2026 opdateret af: Arwa Salah Abdelaziz Ali, Assiut University
In the emergency department, tube thoracostomy is a common critical procedure to manage symptomatic pleural issues such as pneumothorax and pleural effusion.[1]
This technique employed to remove air or fluid from the pleural cavity, restore negative intrapleural pressure and let the lungs expand again to help normal cardiopulmonary function to be restored again.
[2] However, the procedure is often associated with significant pain, with approximately 50% of patients reporting pain levels between 9-10 out of 10 during the intervention, and for pain management emergency physicians have traditionally combined local anesthetics with opioids or anxiolytics.
Yet, these methods have notable drawbacks: opioids carry risks of addiction and adverse side effects (e.g., nausea/vomiting, respiratory depression, delirium), while procedural sedation is time-intensive, requires monitoring, and carries risks of complications such as apnea and hypotension.[3]
Local anesthetic infiltration for pain management can also fail to effectively and evenly target the intercostal nerves responsible for chest wall sensation.[4]
Ultrasound-guided fascial plane blocks (erector spinae plane and serratus plane blocks) have recently been proposed as targeted alternatives for reliable and extended pain control of tube thoracostomy as each block produces a unique distribution of anesthesia.
[5] Despite establishing of these techniques for pain control during thoracic surgeries, its application in emergency settings for tube thoracostomy is underexplored enough yet [6], a gap explicitly identified in the recent literature.[4]
Therefore, in this study we evaluate the impact of ESP and SAP block for pain management and overall quality of recovery which practically performed by emergency physicians.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Arwa Salah Arwa
- Telefonnummer: 00201156748809
- E-mail: arwasalah.ed@gmail.com
Studiesteder
-
-
-
Asyut, Egypten
- Assiut University hospital
-
Kontakt:
- Assuit university hospital
- Telefonnummer: 00201156748809
- E-mail: arwaabdelaziz.54@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Adults aged ≥18 to =<60 years presenting to the ED requiring tube thoracostomy.
- hemodynamically stable (systolic blood pressure ≥90 mmHg).
- Able to provide informed consent.
Exclusion Criteria:
- Tension pneumothorax or hemodynamic instability requiring immediate tube insertion without time for block performance.
- Known allergy or hypersensitivity to local anesthetics.
- Infection or cellulitis overlying the intended needle insertion site.
- Chronic opioid use/dependence, or substance use disorder that would confound pain and opioid-consumption outcomes.
- Psychiatric illness, cognitive impairment, intoxication, or severe traumatic brain injury (GCS < 13) precluding reliable pain-score reporting or informed consent.
- Body mass index ≥ 30 kg/m² (sonoanatomic landmarks less reliable).
- Patients with spinal injury.
- Patinets with fracture rib.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ESPB
|
Ultrasound-guided fascial plane block,Erector spinae plane block for reliable and extended pain control of tube thoracostomy using 20-30 mL of bupivacaine 0.25%.
|
|
Eksperimentel: SAPB
|
Ultrasound-guided fascial plane block,serratus plane blocks for reliable and extended pain control of tube thoracostomy using 20-30 mL of bupivacaine 0.25%
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Intraprocedural pain score (NRS 0-10) recorded immediately after tube insertion and pleural fixation.
Tidsramme: 24 HR
|
24 HR
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Total rescue opioid/sedative dose.
Tidsramme: 24 HR
|
24 HR
|
|
Time required to perform the block (needle-in to needle-out).
Tidsramme: first 24 HR
|
first 24 HR
|
|
procedure-related complications (pneumothorax, hematoma, local anesthetic systemic toxicity, block failure).
Tidsramme: first 24 HR
|
first 24 HR
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Anderson D, Chen SA, Godoy LA, Brown LM, Cooke DT. Comprehensive Review of Chest Tube Management: A Review. JAMA Surg. 2022 Mar 1;157(3):269-274. doi: 10.1001/jamasurg.2021.7050.
- Lopez E, Sahni R, Cooper M, Shalaby M. Serratus Anterior Plane Block for Procedural Anesthesia for Pigtail Tube Thoracostomy: A Case Series. Clin Pract Cases Emerg Med. 2025 Jan;9(1):5-9. doi: 10.5811/cpcem.21251.
- Reeves MT, Lee Y, Shalaby M. Ultrasound-Guided Truncal Blocks for Tube Thoracostomy Analgesia in the Emergency Department. J Emerg Med. 2026 May;84:92-101. doi: 10.1016/j.jemermed.2025.12.026. Epub 2026 Jan 2.
- Rech MA, Griggs C, Lovett S, Motov S. Acute pain management in the Emergency Department: Use of multimodal and non-opioid analgesic treatment strategies. Am J Emerg Med. 2022 Aug;58:57-65. doi: 10.1016/j.ajem.2022.05.022. Epub 2022 May 22.
- Park BC, Mallemat H. Special Procedures for Pulmonary Disease in the Emergency Department. Emerg Med Clin North Am. 2022 Aug;40(3):583-602. doi: 10.1016/j.emc.2022.05.009.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2027
Primær færdiggørelse (Anslået)
30. december 2029
Studieafslutning (Anslået)
30. december 2029
Datoer for studieregistrering
Først indsendt
11. september 2026
Først indsendt, der opfyldte QC-kriterier
11. september 2026
Først opslået (Faktiske)
17. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Tube thoracostomy pain control
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
all collected IPD
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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