Multiple Rib FracturesNCT04575272
Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures
A study testing Ultrasound-guided continuous serratus anterior plane block in people with Multiple Rib Fractures and Pain, Acute, run by Assiut University at 1 site in Egypt.
Trial summary
The present clinical study will be undertaken to evaluate the effect of Ultrasound-guided Deep versus Superficial continuous Serratus Anterior Plane Block for pain management in patients with multiple rib fractures. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Rib Fractures, Pain, Acute, Serratus Anterior Plane Block
- What is being tested?
- Ultrasound-guided continuous serratus anterior plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2021to 10 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult patients of either sex, having three or more unilateral fracture ribs and admitted to the trauma ICU, Rib fractures were confirmed by X-ray and CT scan reads.
Who cannot join
- significant head injury and unconsciousness (GCS less than 14)
- Patients with significant pain from other injuries
- pathological obesity (body mass index ≥35)
- history of drug allergy local anesthetics
- local infection at the injection site
- inability to obtain consent from patient or surrogate, and patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures: Randomized Double-blind Clinical Trial
The present clinical study will be undertaken to evaluate the effect of Ultrasound-guided Deep versus Superficial continuous Serratus Anterior Plane Block for pain management in patients with multiple rib fractures.
Read the detailed description
Thoracic blunt trauma, especially when multiple rib fractures are associated, is challenging to manage and causes significant morbidity due to the severe pain implied.
Patients can present with respiratory compromise as their capacity to expand the thorax is limited by pain. As a result, they are at high risk to develop atelectasis and pneumonia.
the key goal of management is adequate analgesia and pulmonary volume expansion Various strategies to treat such pain have been utilized, including regional analgesia (intrapleural, intercostal paravertebral nerve blockade), and neuraxial analgesia (thoracic epidural analgesia (TEA), intrathecal opioids).
The use of neuraxial analgesia in polytrauma is frequently limited by the need for aggressive venous thromboembolic (VTE) prophylaxis, and positioning of the patient for a neuraxial approach may be impossible.
There is a growing interest in exploring treatments that are less invasive than EA and can be performed on patients who have contraindications to neuraxial analgesia. Ultrasound-guided Serratus Anterior Plane (SAP) block is a recent technique, first described by Blanco et al. in 2013, that provides analgesia for the thoracic wall by blocking the lateral branches of the intercostal nerves from T2 to L2. It is a safe, simple to perform block with no significant contraindications or side effects. he described 2 potential spaces, one superficial and another deep to serratus. The SAPB has been used effectively for the management of pain in the context of rib fractures, thoracoscopic surgery, thoracotomy, breast surgery, and post-mastectomy pain syndrome, few studies compared the two approaches, and the difference between them has not yet been studied in patients with multiple rib fractures.
- Being tested
- Ultrasound-guided continuous serratus anterior plane block
- Keywords
- serratus anterior plane block, multiple rib fractures
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided continuous serratus anterior plane blockProcedure or surgery
Local anesthetic infusion though a peripheral nerve catheter placed related to the serratus anterior muscle at the level of the 5th rib
| Study group | Role | What they receive |
|---|---|---|
| Continuous Deep Serratus Anterior Plane Block group | Experimental | at the level of the fifth rib in the mid-axillary line. After anaesthetizing the skin with 2 mL of lidocaine 2%, an 18-gauge Touhy needle was introduced in-plane, under direct visualization, to the plane immediately deep to the serratus anterior muscle. After negative aspiration, 35 mL of bupivacaine 0.25% will be injected. Afterwards, a 20-gauge peripheral nerve catheter will be threaded into the space. then bupivacaine 0.125% infusion at a rate of 5 ml/h by an Infusion Syringe Pump will be started. Receives: Procedure: Ultrasound-guided continuous serratus anterior plane block |
| Continuous Superficial Serratus Anterior Plane Block group | Active comparator | at the level of the fifth rib in the mid-axillary line. After anaesthetizing the skin with 2 mL of lidocaine 2%, an 18-gauge Touhy needle was introduced in-plane, under direct visualization, to the plane immediately superficial to the serratus anterior muscle. After negative aspiration, 35 mL of bupivacaine 0.25% will be injected. Afterwards, a 20-gauge peripheral nerve catheter will be threaded into the space. then bupivacaine 0.125% infusion at a rate of 5 ml/h by an Infusion Syringe Pump will be started. Receives: Procedure: Ultrasound-guided continuous serratus anterior plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain score
patient report numerical rating scale (NRS) 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable"
Measured: before and after the block at "30 minutes", "2hours", "4hours", "6hours", "12hours", "24hours", "36hours", "48 hours" & "72hours"
Secondary outcomes (6)
Change in inspiratory volumes (mL)
Maximum inspiratory respiratory volume (measured in ml) recorded on single use of incentive spirometer device
Measured: before and after block at "90 minutes" then every "12hours" for 3 days
change in Serum beta-endorphin level
We will use radioimmunoassays to measure plasma beta-endorphin level
Measured: before procedure and at 24 hours post procedure
Lung Ultrasound Score (LUSS)
We will use a techniques based on the international evidence-based recommendations for point-of-care lung ultrasound that recommended using a complete eight-zone lung ultrasound ,The worst ultrasound pattern observed in each zone was recorded and used to calculate the sum of the scores (total score = 24).
Measured: before and after block at "90 minutes" then every "24 hours" for 3 days
mean arterial blood pressure
mean arterial blood pressure by non invaisive blood pressure monitoring
Measured: before and after the block every "2hours" for 3 days
heart rate
heart rate by EKG monitor
Measured: before and after the block every "2hours" for 3 days
peripheral arterial oxygen saturation (SpO2)
measured by Pulse oximetry
Measured: before and after the block every "2hours" for 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start3 Aug 2021
- Primary completion10 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Multiple Rib FracturesStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed mamdouh mohammed mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575272
- Sponsor's protocol ID
- Serratus Plane Block and MFRs
- Status last verified
- Apr 2024
- First submitted
- 20 Sep 2020
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
May L, Hillermann C, Patil S. Rib fracture management. BJA Educ. 2016 Jan 1;16(1):26-32.
Chien CY, Chen YH, Han ST, Blaney GN, Huang TS, Chen KF. The number of displaced rib fractures is more predictive for complications in chest trauma patients. Scand J Trauma Resusc Emerg Med. 2017 Feb 28;25(1):19. doi: 10.1186/s13049-017-0368-y.
PubMed 28241883Lotfipour S, Kaku SK, Vaca FE, Patel C, Anderson CL, Ahmed SS, Menchine MD. Factors associated with complications in older adults with isolated blunt chest trauma. West J Emerg Med. 2009 May;10(2):79-84.
PubMed 19561823Vasigh A, Jaafarpour M, Khajavikhan J, Khani A. The Effect of Gabapentin Plus Celecoxib on Pain and Associated Complications After Laminectomy. J Clin Diagn Res. 2016 Mar;10(3):UC04-8. doi: 10.7860/JCDR/2016/17923.7346. Epub 2016 Mar 1.
PubMed 27134973Khalil AE, Abdallah NM, Bashandy GM, Kaddah TA. Ultrasound-Guided Serratus Anterior Plane Block Versus Thoracic Epidural Analgesia for Thoracotomy Pain. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):152-158. doi: 10.1053/j.jvca.2016.08.023. Epub 2016 Aug 21.
PubMed 27939192Hernandez N, de Haan J, Clendeninn D, Meyer DE, Ghebremichael S, Artime C, Williams G, Eltzschig H, Sen S. Impact of serratus plane block on pain scores and incentive spirometry volumes after chest trauma. Local Reg Anesth. 2019 Aug 2;12:59-66. doi: 10.2147/LRA.S207791. eCollection 2019.
PubMed 31447581Okmen K, Okmen BM. The efficacy of serratus anterior plane block in analgesia for thoracotomy: a retrospective study. J Anesth. 2017 Aug;31(4):579-585. doi: 10.1007/s00540-017-2364-9. Epub 2017 Apr 26.
PubMed 28447227Beard L, Hillermann C, Beard E, Millerchip S, Sachdeva R, Gao Smith F, Veenith T. Multicenter longitudinal cross-sectional study comparing effectiveness of serratus anterior plane, paravertebral and thoracic epidural for the analgesia of multiple rib fractures. Reg Anesth Pain Med. 2020 May;45(5):351-356. doi: 10.1136/rapm-2019-101119. Epub 2020 Mar 11.
PubMed 32165553Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
PubMed 23923989Durant E, Dixon B, Luftig J, Mantuani D, Herring A. Ultrasound-guided serratus plane block for ED rib fracture pain control. Am J Emerg Med. 2017 Jan;35(1):197.e3-197.e6. doi: 10.1016/j.ajem.2016.07.021. Epub 2016 Jul 19. No abstract available.
PubMed 27595172Piracha MM, Thorp SL, Puttanniah V, Gulati A. "A Tale of Two Planes": Deep Versus Superficial Serratus Plane Block for Postmastectomy Pain Syndrome. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):259-262. doi: 10.1097/AAP.0000000000000555.
PubMed 28079733Zocca JA, Chen GH, Puttanniah VG, Hung JC, Gulati A. Ultrasound-Guided Serratus Plane Block for Treatment of Postmastectomy Pain Syndromes in Breast Cancer Patients: A Case Series. Pain Pract. 2017 Jan;17(1):141-146. doi: 10.1111/papr.12482. Epub 2016 Sep 2.
PubMed 27587333Bhoi D, Selvam V, Yadav P, Talawar P. Comparison of two different techniques of serratus anterior plane block: A clinical experience. J Anaesthesiol Clin Pharmacol. 2018 Apr-Jun;34(2):251-253. doi: 10.4103/joacp.JOACP_294_16. No abstract available.
PubMed 30104841Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.
PubMed 16984837
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures: Randomized Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04575272
- Acronym / sponsor ID
- Serratus Plane Block and MFRs
- Keywords
- serratus anterior plane block, multiple rib fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 5 Oct 2020 (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.
The present clinical study will be undertaken to evaluate the effect of Ultrasound-guided Deep versus Superficial continuous Serratus Anterior Plane Block for pain management in patients with multiple rib fractures.
Detailed description
Thoracic blunt trauma, especially when multiple rib fractures are associated, is challenging to manage and causes significant morbidity due to the severe pain implied.
Patients can present with respiratory compromise as their capacity to expand the thorax is limited by pain. As a result, they are at high risk to develop atelectasis and pneumonia.
the key goal of management is adequate analgesia and pulmonary volume expansion Various strategies to treat such pain have been utilized, including regional analgesia (intrapleural, intercostal paravertebral nerve blockade), and neuraxial analgesia (thoracic epidural analgesia (TEA), intrathecal opioids).
The use of neuraxial analgesia in polytrauma is frequently limited by the need for aggressive venous thromboembolic (VTE) prophylaxis, and positioning of the patient for a neuraxial approach may be impossible.
There is a growing interest in exploring treatments that are less invasive than EA and can be performed on patients who have contraindications to neuraxial analgesia. Ultrasound-guided Serratus Anterior Plane (SAP) block is a recent technique, first described by Blanco et al. in 2013, that provides analgesia for the thoracic wall by blocking the lateral branches of the intercostal nerves from T2 to L2. It is a safe, simple to perform block with no significant contraindications or side effects. he described 2 potential spaces, one superficial and another deep to serratus. The SAPB has been used effectively for the management of pain in the context of rib fractures, thoracoscopic surgery, thoracotomy, breast surgery, and post-mastectomy pain syndrome, few studies compared the two approaches, and the difference between them has not yet been studied in patients with multiple rib fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Deep Serratus Anterior Plane Block group | Experimental | Procedure: Ultrasound-guided continuous serratus anterior plane blockat the level of the fifth rib in the mid-axillary line. After anaesthetizing the skin with 2 mL of lidocaine 2%, an 18-gauge Touhy needle was introduced in-plane, under direct visualization, to the plane immediately deep to the serratus anterior muscle. After negative aspiration, 35 mL of bupivacaine 0.25% will be injected. Afterwards, a 20-gauge peripheral nerve catheter will be threaded into the space. then bupivacaine 0.125% infusion at a rate of 5 ml/h by an Infusion Syringe Pump will be started. |
| Continuous Superficial Serratus Anterior Plane Block group | Active comparator | Procedure: Ultrasound-guided continuous serratus anterior plane blockat the level of the fifth rib in the mid-axillary line. After anaesthetizing the skin with 2 mL of lidocaine 2%, an 18-gauge Touhy needle was introduced in-plane, under direct visualization, to the plane immediately superficial to the serratus anterior muscle. After negative aspiration, 35 mL of bupivacaine 0.25% will be injected. Afterwards, a 20-gauge peripheral nerve catheter will be threaded into the space. then bupivacaine 0.125% infusion at a rate of 5 ml/h by an Infusion Syringe Pump will be started. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients of either sex, having three or more unilateral fracture ribs and admitted to the trauma ICU, Rib fractures were confirmed by X-ray and CT scan reads.
Key exclusion criteria (6 listed)
- significant head injury and unconsciousness (GCS less than 14)
- Patients with significant pain from other injuries
- pathological obesity (body mass index ≥35)
- history of drug allergy local anesthetics
- local infection at the injection site
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 |
|---|---|---|
| Ultrasound-guided continuous serratus anterior plane blockLocal anesthetic infusion though a peripheral nerve catheter placed related to the serratus anterior muscle at the level of the 5th rib | Procedure or surgery | Continuous Deep Serratus Anterior Plane Block group, Continuous Superficial Serratus Anterior Plane Block group |
Primary outcome
Change in pain score
Time frame: before and after the block at "30 minutes", "2hours", "4hours", "6hours", "12hours", "24hours", "36hours", "48 hours" & "72hours"
patient report numerical rating scale (NRS) 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable"
6 secondary outcomes
Change in inspiratory volumes (mL)
Time frame: before and after block at "90 minutes" then every "12hours" for 3 days
change in Serum beta-endorphin level
Time frame: before procedure and at 24 hours post procedure
Lung Ultrasound Score (LUSS)
Time frame: before and after block at "90 minutes" then every "24 hours" for 3 days
mean arterial blood pressure
Time frame: before and after the block every "2hours" for 3 days
heart rate
Time frame: before and after the block every "2hours" for 3 days
peripheral arterial oxygen saturation (SpO2)
Time frame: before and after the block every "2hours" for 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- BackgroundMay L, Hillermann C, Patil S. Rib fracture management. BJA Educ. 2016 Jan 1;16(1):26-32.
- Background: PubMed 28241883Chien CY, Chen YH, Han ST, Blaney GN, Huang TS, Chen KF. The number of displaced rib fractures is more predictive for complications in chest trauma patients. Scand J Trauma Resusc Emerg Med. 2017 Feb 28;25(1):19. doi: 10.1186/s13049-017-0368-y.
- Background: PubMed 19561823Lotfipour S, Kaku SK, Vaca FE, Patel C, Anderson CL, Ahmed SS, Menchine MD. Factors associated with complications in older adults with isolated blunt chest trauma. West J Emerg Med. 2009 May;10(2):79-84.
- Background: PubMed 27134973Vasigh A, Jaafarpour M, Khajavikhan J, Khani A. The Effect of Gabapentin Plus Celecoxib on Pain and Associated Complications After Laminectomy. J Clin Diagn Res. 2016 Mar;10(3):UC04-8. doi: 10.7860/JCDR/2016/17923.7346. Epub 2016 Mar 1.
- Background: PubMed 27939192Khalil AE, Abdallah NM, Bashandy GM, Kaddah TA. Ultrasound-Guided Serratus Anterior Plane Block Versus Thoracic Epidural Analgesia for Thoracotomy Pain. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):152-158. doi: 10.1053/j.jvca.2016.08.023. Epub 2016 Aug 21.
- Background: PubMed 31447581Hernandez N, de Haan J, Clendeninn D, Meyer DE, Ghebremichael S, Artime C, Williams G, Eltzschig H, Sen S. Impact of serratus plane block on pain scores and incentive spirometry volumes after chest trauma. Local Reg Anesth. 2019 Aug 2;12:59-66. doi: 10.2147/LRA.S207791. eCollection 2019.
- Background: PubMed 28447227Okmen K, Okmen BM. The efficacy of serratus anterior plane block in analgesia for thoracotomy: a retrospective study. J Anesth. 2017 Aug;31(4):579-585. doi: 10.1007/s00540-017-2364-9. Epub 2017 Apr 26.
- Background: PubMed 32165553Beard L, Hillermann C, Beard E, Millerchip S, Sachdeva R, Gao Smith F, Veenith T. Multicenter longitudinal cross-sectional study comparing effectiveness of serratus anterior plane, paravertebral and thoracic epidural for the analgesia of multiple rib fractures. Reg Anesth Pain Med. 2020 May;45(5):351-356. doi: 10.1136/rapm-2019-101119. Epub 2020 Mar 11.
- Background: PubMed 23923989Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
- Background: PubMed 27595172Durant E, Dixon B, Luftig J, Mantuani D, Herring A. Ultrasound-guided serratus plane block for ED rib fracture pain control. Am J Emerg Med. 2017 Jan;35(1):197.e3-197.e6. doi: 10.1016/j.ajem.2016.07.021. Epub 2016 Jul 19. No abstract available.
- Background: PubMed 28079733Piracha MM, Thorp SL, Puttanniah V, Gulati A. "A Tale of Two Planes": Deep Versus Superficial Serratus Plane Block for Postmastectomy Pain Syndrome. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):259-262. doi: 10.1097/AAP.0000000000000555.
- Background: PubMed 27587333Zocca JA, Chen GH, Puttanniah VG, Hung JC, Gulati A. Ultrasound-Guided Serratus Plane Block for Treatment of Postmastectomy Pain Syndromes in Breast Cancer Patients: A Case Series. Pain Pract. 2017 Jan;17(1):141-146. doi: 10.1111/papr.12482. Epub 2016 Sep 2.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided continuous serratus anterior plane block in people with Multiple Rib Fractures and Pain, Acute, 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 24 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score (time frame: before and after the block at "30 minutes", "2hours", "4hours", "6hours", "12hours", "24hours", "36hours", "48 hours" & "72hours"). 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 NCT04575272, which also lists 16 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 24 Apr 2024.