Complex Regional Pain SyndromesNCT06468384
Sympatholytic Effects of High Thoracic Erector Spinae Plane Block: Changes in Optic Nerve Sheath Diameter
An observational study of Complex Regional Pain Syndromes, run by Pamukkale University.
Trial summary
The thoracic erector spinae plane (ESP) block is suggested to potentially affect the stellate ganglion, a key component of the sympathetic nervous system, thereby influencing autonomic functions. Changes in optic nerve sheath diameter (ONSD) are used as indicators of intracranial pressure changes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- thoracic erector spinae plane (ESP) block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2024to 20 Sep 2024
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Adults with neck, shoulder, and arm pain * Those with complex regional pain syndrome The study will include 15 adult patients who are planned to receive T2-ESP block treatment. * Age between 18-65 years * Both genders * ASA physical status I-II
Who may be able to join
- Adults with neck, shoulder, and arm pain
- Those with complex regional pain syndrome
- The study will include 15 adult patients who are planned to receive T2-ESP block treatment.
- Age between 18-65 years
- Both genders
- ASA physical status I-II
Who cannot join
- Those who refuse procedures and tests
- Individuals with conditions that can increase intracranial pressure
- Those with severe heart failure
- Individuals with second or third-degree atrioventricular block
- Those with a history of unstable angina
- Individuals with COPD or chronic asthma
Show all 15Show fewer
- Those who have experienced a myocardial infarction (MI) within the last 6 weeks
- Individuals with a heart rate below 50 beats per minute
- Those with systolic blood pressure below 90 mmHg
- Individuals with liver failure
- Those with kidney failure
- Individuals for whom a supraclavicular block is anatomically impossible
- Those with neurological or psychological conditions that complicate test evaluation
- Individuals allergic to any of the study medications
- Pregnant individuals
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sympatholytic Effects of High Thoracic Erector Spinae Plane Block: A Prospective Observational Study on Changes in Optic Nerve Sheath Diameter
The thoracic erector spinae plane (ESP) block is suggested to potentially affect the stellate ganglion, a key component of the sympathetic nervous system, thereby influencing autonomic functions. Changes in optic nerve sheath diameter (ONSD) are used as indicators of intracranial pressure changes. This study aims to investigate the effects of the ESP block on ONSD, providing insights into its impact on the stellate ganglion and enhancing the understanding of the ESP block's safety and efficacy.
Read the detailed description
The thoracic erector spinae plane (ESP) block is a regional anesthesia technique. This technique involves the injection of local anesthetics into the deep layers of the erector spinae muscles, blocking both somatic and visceral pain pathways. Although various studies have been conducted on the effectiveness of this technique in different clinical situations over the years, further research is needed to understand the precise mechanisms behind its neuroanatomical effects.
The stellate ganglion, an important component of the sympathetic nervous system, plays a crucial role in the regulation of several autonomic functions. It has been suggested that the ESP block may affect the stellate ganglion through its injection at the upper thoracic levels. Changes in the optic nerve sheath diameter (ONSD) have been used as an important indicator of intracranial pressure changes. Any potential changes in ONSD following stellate ganglion blockade could help elucidate the effects of the ESP block, thus aiding in the understanding of its safety and potential benefits for analgesia.
The aim of this study is to investigate the changes in optic nerve sheath diameter in patients undergoing the thoracic ESP block, which could provide more information on the impact of the ESP block on the stellate ganglion. By doing so, we aim to gain further insights into the potential analgesic effects and safety of the ESP block.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- thoracic erector spinae plane (ESP) block
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic erector spinae plane (ESP) blockProcedure or surgery
The thoracic erector spinae plane (ESP) block is a regional anesthesia technique used for pain management in complex regional pain syndrome. This procedure involves injecting 20 ml of 0.25% bupivacaine into the deep layers of the erector spinae muscles. The patient is positioned appropriately, and the injection site is identified using anatomical landmarks and ultrasound guidance, at the T2 level. A needle is then inserted perpendicularly until it contacts the transverse process, at which point the local anesthetic is administered. The primary objective is to provide significant pain relief.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Thoracic Erector Spinae Plane Block | The study focuses on a cohort of adult patients who are receiving the thoracic erector spinae plane (ESP) block for pain management. These patients include individuals experiencing pain in the shoulder, arm, or neck, as well as those with complex regional pain syndrome. The patients are generally healthy adults, categorized under ASA I-II (American Society of Anesthesiologists Physical Status Classification System). The primary aim of the study is to observe changes in optic nerve sheath diameter (ONSD) following the ESP block and to investigate the potential impact on the stellate ganglion. Data will be collected through clinical examinations and ultrasound performed before and after the ESP block procedure. The study aims to enhance understanding of the ESP block's safety and potential autonomic effects. Receives: Procedure: thoracic erector spinae plane (ESP) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter (ONSD)
To investigate the change in optic nerve sheath diameter (ONSD) following the thoracic erector spinae plane (ESP) block.
Measured: Before the block and 30 minutes after the block.
Secondary outcomes (2)
Pain relief Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a tool for measuring pain intensity, using a line marked with "no pain" (0) at one end and "worst pain imaginable" (10) at the other. Patients mark a point on the line that reflects their pain level, and the distance from the "no pain" end to the mark is recorded as the VAS score. This straightforward, subjective measure provides a quantitative assessment of pain, useful for tracking changes over time, evaluating treatment effectiveness, and enhancing communication between patients and healthcare providers.
Measured: Pain levels will be assessed using the VAS before the block, 30 minutes after the block, and 24 hours later to evaluate the effectiveness of the intervention.
Monitoring of Perfusion Index (PI)
The perfusion index (PI) is a numerical value that reflects the pulsatile blood flow in peripheral tissues, measured non-invasively using a pulse oximeter. It indicates the strength of the blood flow at the sensor site, providing valuable information about peripheral perfusion.
Measured: All perfusion index (PI) values will be measured at 3-minute intervals using 2 pulse oximeter sensors on both the blocked and contralateral unblocked upper extremities up to 30 minutes after local anesthetic injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start20 Jun 2024 (estimated)
- Primary completion20 Aug 2024 (estimated)
- Study completion20 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ismet çopur, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468384
- Sponsor's protocol ID
- PAU-ANEST-SI-IC-01
- Status last verified
- Jun 2024
- First submitted
- 15 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.
PubMed 33403545Shirodkar CG, Munta K, Rao SM, Mahesh MU. Correlation of measurement of optic nerve sheath diameter using ultrasound with magnetic resonance imaging. Indian J Crit Care Med. 2015 Aug;19(8):466-70. doi: 10.4103/0972-5229.162465.
PubMed 26321806Kim E, Lim JA, Choi CH, Lee SY, Kwak S, Kim J. Assessment of the changes in cardiac sympathetic nervous activity using the pupil size changes measured in seated patients whose stellate ganglion is blocked by interscalene brachial plexus block. Korean J Anesthesiol. 2023 Apr;76(2):116-127. doi: 10.4097/kja.22324. Epub 2022 Oct 24.
PubMed 36274253Maissan IM, Dirven PJ, Haitsma IK, Hoeks SE, Gommers D, Stolker RJ. Ultrasonographic measured optic nerve sheath diameter as an accurate and quick monitor for changes in intracranial pressure. J Neurosurg. 2015 Sep;123(3):743-7. doi: 10.3171/2014.10.JNS141197. Epub 2015 May 8.
PubMed 25955869Kim MS, Yoon KB, Yoon DM, Kim DH. Effect of cervical sympathetic block on optic nerve sheath diameter measured by ultrasonography. Ultrasound Med Biol. 2015 Jun;41(6):1599-604. doi: 10.1016/j.ultrasmedbio.2015.01.025. Epub 2015 Mar 5.
PubMed 25747936Dautzenberg KHW, Zegers MJ, Bleeker CP, Tan ECTH, Vissers KCP, van Geffen GJ, van der Wal SEI. Unpredictable Injectate Spread of the Erector Spinae Plane Block in Human Cadavers. Anesth Analg. 2019 Nov;129(5):e163-e166. doi: 10.1213/ANE.0000000000004187.
PubMed 31107261Forero M, Peng P, Chan P. Horner syndrome following high thoracic erector spinae plane block. Can J Anaesth. 2022 Mar;69(3):400-401. doi: 10.1007/s12630-021-02177-x. Epub 2021 Dec 13. No abstract available.
PubMed 34902105Elkoundi A, Eloukkal Z, Bensghir M, Belyamani L. Priapism following erector spinae plane block for the treatment of a complex regional pain syndrome. Am J Emerg Med. 2019 Apr;37(4):796.e3-796.e4. doi: 10.1016/j.ajem.2019.01.012. Epub 2019 Jan 11.
PubMed 30660341Hong JH, Park JH, Park KB, Lee JY. Sympatholytic Effect of the High Thoracic Erector Spinae Plane Block. Pain Physician. 2024 Jan;27(1):43-49.
PubMed 38285034
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympatholytic Effects of High Thoracic Erector Spinae Plane Block: A Prospective Observational Study on Changes in Optic Nerve Sheath Diameter
- ClinicalTrials.gov ID
- NCT06468384
- Acronym / sponsor ID
- PAU-ANEST-SI-IC-01
- Conditions
- Complex Regional Pain Syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 21 Jun 2024 (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 thoracic erector spinae plane (ESP) block is suggested to potentially affect the stellate ganglion, a key component of the sympathetic nervous system, thereby influencing autonomic functions. Changes in optic nerve sheath diameter (ONSD) are used as indicators of intracranial pressure changes. This study aims to investigate the effects of the ESP block on ONSD, providing insights into its impact on the stellate ganglion and enhancing the understanding of the ESP block's safety and efficacy.
Detailed description
The thoracic erector spinae plane (ESP) block is a regional anesthesia technique. This technique involves the injection of local anesthetics into the deep layers of the erector spinae muscles, blocking both somatic and visceral pain pathways. Although various studies have been conducted on the effectiveness of this technique in different clinical situations over the years, further research is needed to understand the precise mechanisms behind its neuroanatomical effects.
The stellate ganglion, an important component of the sympathetic nervous system, plays a crucial role in the regulation of several autonomic functions. It has been suggested that the ESP block may affect the stellate ganglion through its injection at the upper thoracic levels. Changes in the optic nerve sheath diameter (ONSD) have been used as an important indicator of intracranial pressure changes. Any potential changes in ONSD following stellate ganglion blockade could help elucidate the effects of the ESP block, thus aiding in the understanding of its safety and potential benefits for analgesia.
The aim of this study is to investigate the changes in optic nerve sheath diameter in patients undergoing the thoracic ESP block, which could provide more information on the impact of the ESP block on the stellate ganglion. By doing so, we aim to gain further insights into the potential analgesic effects and safety of the ESP block.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Thoracic Erector Spinae Plane Block | – | Procedure: thoracic erector spinae plane (ESP) blockThe study focuses on a cohort of adult patients who are receiving the thoracic erector spinae plane (ESP) block for pain management. These patients include individuals experiencing pain in the shoulder, arm, or neck, as well as those with complex regional pain syndrome. The patients are generally healthy adults, categorized under ASA I-II (American Society of Anesthesiologists Physical Status Classification System). The primary aim of the study is to observe changes in optic nerve sheath diameter (ONSD) following the ESP block and to investigate the potential impact on the stellate ganglion. Data will be collected through clinical examinations and ultrasound performed before and after the ESP block procedure. The study aims to enhance understanding of the ESP block's safety and potential autonomic effects. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Adults with neck, shoulder, and arm pain * Those with complex regional pain syndrome The study will include 15 adult patients who are planned to receive T2-ESP block treatment. * Age between 18-65 years * Both genders * ASA physical status I-II
Key inclusion criteria (6 listed)
- Adults with neck, shoulder, and arm pain
- Those with complex regional pain syndrome
- The study will include 15 adult patients who are planned to receive T2-ESP block treatment.
- Age between 18-65 years
- Both genders
Key exclusion criteria (15 listed)
- Those who refuse procedures and tests
- Individuals with conditions that can increase intracranial pressure
- Those with severe heart failure
- Individuals with second or third-degree atrioventricular block
- Those with a history of unstable angina
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 |
|---|---|---|
| thoracic erector spinae plane (ESP) blockThe thoracic erector spinae plane (ESP) block is a regional anesthesia technique used for pain management in complex regional pain syndrome. This procedure involves injecting 20 ml of 0.25% bupivacaine into the deep layers of the erector spinae muscles. The patient is positioned appropriately, and the injection site is identified using anatomical landmarks and ultrasound guidance, at the T2 level. A needle is then inserted perpendicularly until it contacts the transverse process, at which point the local anesthetic is administered. The primary objective is to provide significant pain relief. | Procedure or surgery | Patients Undergoing Thoracic Erector Spinae Plane Block |
Primary outcome
Optic nerve sheath diameter (ONSD)
Time frame: Before the block and 30 minutes after the block.
To investigate the change in optic nerve sheath diameter (ONSD) following the thoracic erector spinae plane (ESP) block.
2 secondary outcomes
Pain relief Visual Analog Scale (VAS)
Time frame: Pain levels will be assessed using the VAS before the block, 30 minutes after the block, and 24 hours later to evaluate the effectiveness of the intervention.
Monitoring of Perfusion Index (PI)
Time frame: All perfusion index (PI) values will be measured at 3-minute intervals using 2 pulse oximeter sensors on both the blocked and contralateral unblocked upper extremities up to 30 minutes after local anesthetic injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Results publication: PubMed 33403545Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.
- Results publication: PubMed 26321806Shirodkar CG, Munta K, Rao SM, Mahesh MU. Correlation of measurement of optic nerve sheath diameter using ultrasound with magnetic resonance imaging. Indian J Crit Care Med. 2015 Aug;19(8):466-70. doi: 10.4103/0972-5229.162465.
- Results publication: PubMed 36274253Kim E, Lim JA, Choi CH, Lee SY, Kwak S, Kim J. Assessment of the changes in cardiac sympathetic nervous activity using the pupil size changes measured in seated patients whose stellate ganglion is blocked by interscalene brachial plexus block. Korean J Anesthesiol. 2023 Apr;76(2):116-127. doi: 10.4097/kja.22324. Epub 2022 Oct 24.
- Results publication: PubMed 25955869Maissan IM, Dirven PJ, Haitsma IK, Hoeks SE, Gommers D, Stolker RJ. Ultrasonographic measured optic nerve sheath diameter as an accurate and quick monitor for changes in intracranial pressure. J Neurosurg. 2015 Sep;123(3):743-7. doi: 10.3171/2014.10.JNS141197. Epub 2015 May 8.
- Results publication: PubMed 25747936Kim MS, Yoon KB, Yoon DM, Kim DH. Effect of cervical sympathetic block on optic nerve sheath diameter measured by ultrasonography. Ultrasound Med Biol. 2015 Jun;41(6):1599-604. doi: 10.1016/j.ultrasmedbio.2015.01.025. Epub 2015 Mar 5.
- Results publication: PubMed 31107261Dautzenberg KHW, Zegers MJ, Bleeker CP, Tan ECTH, Vissers KCP, van Geffen GJ, van der Wal SEI. Unpredictable Injectate Spread of the Erector Spinae Plane Block in Human Cadavers. Anesth Analg. 2019 Nov;129(5):e163-e166. doi: 10.1213/ANE.0000000000004187.
- Results publication: PubMed 34902105Forero M, Peng P, Chan P. Horner syndrome following high thoracic erector spinae plane block. Can J Anaesth. 2022 Mar;69(3):400-401. doi: 10.1007/s12630-021-02177-x. Epub 2021 Dec 13. No abstract available.
- Results publication: PubMed 30660341Elkoundi A, Eloukkal Z, Bensghir M, Belyamani L. Priapism following erector spinae plane block for the treatment of a complex regional pain syndrome. Am J Emerg Med. 2019 Apr;37(4):796.e3-796.e4. doi: 10.1016/j.ajem.2019.01.012. Epub 2019 Jan 11.
- Results publication: PubMed 38285034Hong JH, Park JH, Park KB, Lee JY. Sympatholytic Effect of the High Thoracic Erector Spinae Plane Block. Pain Physician. 2024 Jan;27(1):43-49.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Regional Pain Syndromes, run by Pamukkale University.
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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ismet çopur, MD (05318469060 ext. 90, cpr.ismet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve sheath diameter (ONSD) (time frame: Before the block and 30 minutes after the block.). 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 NCT06468384, which also lists 9 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 21 Jun 2024.