NCT07823920

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Jun 2027

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2027

Expected
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2029

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

2.6 years

First QC Date

September 11, 2026

Last Update Submit

September 11, 2026

Conditions

Keywords

tube thoracostomypain controlpain managment

Outcome Measures

Primary Outcomes (1)

  • Intraprocedural pain score (NRS 0-10) recorded immediately after tube insertion and pleural fixation.

    24 HR

Secondary Outcomes (3)

  • Total rescue opioid/sedative dose.

    24 HR

  • Time required to perform the block (needle-in to needle-out).

    first 24 HR

  • procedure-related complications (pneumothorax, hematoma, local anesthetic systemic toxicity, block failure).

    first 24 HR

Study Arms (2)

SAPB

EXPERIMENTAL
Procedure: serratus anterior plane blocks

ESPB

EXPERIMENTAL
Procedure: Erector Spinae Plane Block

Interventions

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%

SAPB

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%.

ESPB

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University hospital

Asyut, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 39903631BACKGROUND
  • 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.

    PMID: 41936304BACKGROUND
  • 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.

    PMID: 35636044BACKGROUND
  • 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.

    PMID: 35080596BACKGROUND
  • 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.

    PMID: 35953218BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
arwa salah abdelaziz

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 17, 2026

Study Start (Estimated)

June 1, 2027

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 30, 2029

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

all collected IPD

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations