Thoracostomy Pain ManagementNCT07823920
The Clinical Impact of Serratus Anterior VS. Erector Spinae Plane Block on Pain Management of Tube Thoracostomy in Emergency Department Patients.
A study testing serratus anterior plane blocks and Erector Spinae Plane Block in people with Thoracostomy Pain Management and Pain Management, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thoracostomy Pain Management, Pain Management, Chest Tube Insertion
- What is being tested?
- serratus anterior plane blocks and Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2027to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University hospital
Asyut
Assuit university hospital, 00201156748809, arwaabdelaziz.54@gmail.com
About this study
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.
- Being tested
- serratus anterior plane blocks, Erector Spinae Plane Block
- Keywords
- tube thoracostomy, pain control, pain managment
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serratus anterior plane blocksProcedure or surgery
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%
Erector Spinae Plane BlockProcedure or surgery
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%.
| Study group | Role | What they receive |
|---|---|---|
| SAPB | Experimental | Not described Receives: Procedure: serratus anterior plane blocks |
| ESPB | Experimental | Not described Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraprocedural pain score (NRS 0-10) recorded immediately after tube insertion and pleural fixation.
Measured: 24 HR
Secondary outcomes (3)
Total rescue opioid/sedative dose.
Measured: 24 HR
Time required to perform the block (needle-in to needle-out).
Measured: first 24 HR
procedure-related complications (pneumothorax, hematoma, local anesthetic systemic toxicity, block failure).
Measured: first 24 HR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Jun 2027 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Thoracostomy Pain ManagementStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arwa Salah Abdelaziz Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823920
- Sponsor's protocol ID
- Tube thoracostomy pain control
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
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.
PubMed 39903631Reeves 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.
PubMed 41936304Rech 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.
PubMed 35636044Anderson 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.
PubMed 35080596Park 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.
PubMed 35953218
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Impact of Serratus Anterior VS. Erector Spinae Plane Block on Pain Management of Tube Thoracostomy in Emergency Department Patients.
- ClinicalTrials.gov ID
- NCT07823920
- Acronym / sponsor ID
- Tube thoracostomy pain control
- Keywords
- tube thoracostomy, pain control, pain managment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAPB | Experimental | Procedure: serratus anterior plane blocks |
| ESPB | Experimental | Procedure: Erector Spinae Plane Block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serratus anterior plane blocksUltrasound-guided fascial plane block,serratus plane blocks for reliable and extended pain control of tube thoracostomy using 20-30 mL of bupivacaine 0.25% | Procedure or surgery | SAPB |
| Erector Spinae Plane BlockUltrasound-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%. | Procedure or surgery | ESPB |
Primary outcome
Intraprocedural pain score (NRS 0-10) recorded immediately after tube insertion and pleural fixation.
Time frame: 24 HR
3 secondary outcomes
Total rescue opioid/sedative dose.
Time frame: 24 HR
Time required to perform the block (needle-in to needle-out).
Time frame: first 24 HR
procedure-related complications (pneumothorax, hematoma, local anesthetic systemic toxicity, block failure).
Time frame: first 24 HR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 39903631Lopez 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.
- Background: PubMed 41936304Reeves 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.
- Background: PubMed 35636044Rech 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.
- Background: PubMed 35080596Anderson 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.
- Background: PubMed 35953218Park 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.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serratus anterior plane blocks and Erector Spinae Plane Block in people with Thoracostomy Pain Management and Pain Management, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arwa Salah Arwa (00201156748809, arwasalah.ed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraprocedural pain score (NRS 0-10) recorded immediately after tube insertion and pleural fixation. (time frame: 24 HR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07823920, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.