An observational study in Complex Regional Pain Syndromes, sponsored by Pamukkale University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by Pamukkale University · Observational
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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.
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.
206 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.
This study's planned enrollment of 15 is below the median of 58 across 44 observational studies indexed under Complex Regional Pain Syndromes.
Browse Complex Regional Pain Syndromes studies →Pamukkale University is the lead sponsor of 342 studies on the registry; 61 are open to participants now.
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The study will include 15 adult patients who are planned to receive T2-ESP block treatment.
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The study will include 15 adult patients who are planned to receive T2-ESP block treatment.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: thoracic erector spinae plane (ESP) block
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.
Optic nerve sheath diameter (ONSD)
To investigate the change in optic nerve sheath diameter (ONSD) following the thoracic erector spinae plane (ESP) block.
Time frame: Before the block and 30 minutes after the block.
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.
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)
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.
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.
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jun 2024; primary completion for Aug 2024, 2 months later.
Of 18 observational studies under Complex Regional Pain Syndromes, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 147. This study's planned 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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