Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-27 @ 2:12 AM
Study NCT ID:
NCT06336161
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection
Sponsor:
Al-Azhar University
Organization:
Study Overview
Official Title:
Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection in Lumbosacral Spine Surgeries for Postoperative Pain Management
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patient-controlled analgesia is typically used to relieve postoperative pain. Patient-controlled analgesia, on the other hand, is prone to opioid-related side effects. Furthermore, standard postoperative analgesia has a limited analgesic impact. If postoperative lumbosacral spine pain is not successfully treated, it can progress to chronic pain, compromising patients' quality of life.
The methods of access for epidural injections are characterized as transforaminal, interlaminar, or caudal. Caudal epidural injections (CEI) are often utilized as a diagnostic or therapeutic tool in a range of lumbosacral-originating spinal pain problems, and they are especially useful in patients with complicated lumbar epidural access diseases, such as post laminectomy syndrome. It is regarded as a very simple treatment in the realm of interventional pain management, and it is also recognized to have a reduced risk of inadvertent Dural puncture than other epidural techniques
The methods of access for epidural injections are characterized as transforaminal, interlaminar, or caudal. Caudal epidural injections (CEI) are often utilized as a diagnostic or therapeutic tool in a range of lumbosacral-originating spinal pain problems, and they are especially useful in patients with complicated lumbar epidural access diseases, such as post laminectomy syndrome. It is regarded as a very simple treatment in the realm of interventional pain management, and it is also recognized to have a reduced risk of inadvertent Dural puncture than other epidural techniques
Detailed Description:
Patient-controlled analgesia is typically used to relieve postoperative pain. Patient-controlled analgesia, on the other hand, is prone to opioid-related side effects. Furthermore, standard postoperative analgesia has a limited analgesic impact. If postoperative lumbosacral spine pain is not successfully treated, it can progress to chronic pain, compromising patients' quality of life.
Major lumbosacral surgery results in considerable postoperative discomfort that normally lasts at least three days. According to several research, the most discomfort occurs in the first four postoperative hours and gradually decreases by the third postoperative day. Efficient and safe postoperative analgesic treatments following lumbosacral surgery are useful for early recovery and hence required.
Traditional caudal epidural injections, on the other hand, pose a potential risk of epidural venous plexus or dura penetration, with the incidence of accidental intravascular injections, as confirmed by contrast enhanced fluoroscopy, ranging from 11 to 42% in patients who had received caudal epidural injections. Furthermore, there have been a few instances of unintended Dural puncture during the caudal approach because of an unusually low Dural sac termination in the sacral canal.
Such complications of intravascular and intrathecal drug injections might result in systemic toxicity of local anesthetics and complete spinal anesthesia. Thus, ultrasonography (US) can be utilized to guide caudal injections, increasing the efficacy of pain treatment while decreasing the risk of complications and incorrect injections. Previous investigations shown the feasibility of using ultrasound to locate the sacral hiatus and guide the needle into the caudal epidural area, with a reported success rate of 100%.
Another technique for postoperative pain relief is the Erector spinae plane block (ESPB), which was introduced in 2016. It is a relatively new regional anesthesia technique in which local anesthetic is injected into the fascial plane between the transverse process of the vertebra and the erector spinae muscles. It has acquired favor in perioperative analgesia for a variety of surgical procedures, including breast, thoracic, abdominal, and lumbar spine operations.
The addition of US to ESPB allows the needle to be guided to efficiently deposit the anesthetic agents deep to the erector spinae muscle, resulting in the blockage of the ventral and dorsal rami of many spinal neurons, boosting the efficiency of pain control.
Major lumbosacral surgery results in considerable postoperative discomfort that normally lasts at least three days. According to several research, the most discomfort occurs in the first four postoperative hours and gradually decreases by the third postoperative day. Efficient and safe postoperative analgesic treatments following lumbosacral surgery are useful for early recovery and hence required.
Traditional caudal epidural injections, on the other hand, pose a potential risk of epidural venous plexus or dura penetration, with the incidence of accidental intravascular injections, as confirmed by contrast enhanced fluoroscopy, ranging from 11 to 42% in patients who had received caudal epidural injections. Furthermore, there have been a few instances of unintended Dural puncture during the caudal approach because of an unusually low Dural sac termination in the sacral canal.
Such complications of intravascular and intrathecal drug injections might result in systemic toxicity of local anesthetics and complete spinal anesthesia. Thus, ultrasonography (US) can be utilized to guide caudal injections, increasing the efficacy of pain treatment while decreasing the risk of complications and incorrect injections. Previous investigations shown the feasibility of using ultrasound to locate the sacral hiatus and guide the needle into the caudal epidural area, with a reported success rate of 100%.
Another technique for postoperative pain relief is the Erector spinae plane block (ESPB), which was introduced in 2016. It is a relatively new regional anesthesia technique in which local anesthetic is injected into the fascial plane between the transverse process of the vertebra and the erector spinae muscles. It has acquired favor in perioperative analgesia for a variety of surgical procedures, including breast, thoracic, abdominal, and lumbar spine operations.
The addition of US to ESPB allows the needle to be guided to efficiently deposit the anesthetic agents deep to the erector spinae muscle, resulting in the blockage of the ventral and dorsal rami of many spinal neurons, boosting the efficiency of pain control.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: