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This clinical trial aims to evaluate the effectiveness of ultrasound-guided erector spinae plane (ESP) block as an adjunct to general anesthesia for managing postoperative pain in patients undergoing lumbar spondylolisthesis surgery. The study will compare two groups: one receiving general anesthesia with ESP block (intervention group) and the other receiving general anesthesia alone (control group). The primary objective is to assess postoperative pain relief, opioid consumption, and hemodynamic stability. Secondary outcomes include adverse events and recovery quality. This trial will provide valuable insights into the efficacy of ESP block in improving recovery outcomes and reducing opioid use in spine surgery patients.
This study is designed as a quasi-experimental trial to investigate the efficacy of the ultrasound-guided erector spinae plane (ESP) block in combination with general anesthesia for postoperative pain management in patients undergoing lumbar spondylolisthesis surgery. This clinical trial will recruit 50 adult patients scheduled for elective lumbar spine surgery, who are assigned to either the intervention or control group.
Intervention Group (Group B): Patients will receive ultrasound-guided ESP block as an adjunct to standard general anesthesia.
Control Group (Group A): Patients will receive general anesthesia without the erector spinae plane (ESP) block.
The trial will evaluate pain control (measured by Visual Analogue Scale [VAS] scores), opioid consumption, and hemodynamic parameters (such as heart rate, blood pressure, and oxygen saturation). Additionally, postoperative recovery quality, the incidence of adverse events, and any potential complications associated with the erector spinae plane (ESP) block will be monitored and compared between groups.
This trial also aims to assess whether the use of the erector spinae plane (ESP) block can reduce opioid consumption, improve hemodynamic stability, and enhance recovery quality in the postoperative period.
The study will be conducted at Bangladesh Medical University (BMU), Dhaka, with all ethical considerations adhered to, and informed consent will be obtained from all participants before enrollment. Participants will be followed for 24 hours post-surgery, with monitoring at several time points to assess the primary and secondary outcomes.
The results of this study are expected to provide valuable insights into the effectiveness of the erector spinae plane (ESP block) in improving surgical outcomes, reducing opioid use, and enhancing recovery after lumbar spine surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group: General Anesthesia Without Erector Spinae Plane Block | Active Comparator | Control Group: General Anesthesia Without Erector Spinae Plane Block In this group, patients will receive standard general anesthesia without the addition of an ultrasound-guided erector spinae plane (ESP) block. This arm will serve as the comparison group to assess the impact of the ESP block on postoperative pain and recovery outcomes. |
|
| Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block | Experimental | Intervention Group: General Anaesthesia With Ultrasound-Guided Erector Spinae Plane (ESP) Block In this group, patients will receive general anaesthesia in combination with an ultrasound-guided erector spinae plane block. The aim is to evaluate whether adding the ESP block improves postoperative pain control, reduces opioid consumption, and enhances hemodynamic stability during and after lumbar spondylolisthesis surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Group: General Anesthesia Without Erector Spinae Plane Block | Procedure | Intervention Type: Drug - General Anesthesia Description: Patients will receive general anesthesia using standard anesthetic agents (e.g., propofol, fentanyl, and isoflurane) without the addition of a regional block. No erector spinae plane (ESP) block will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Opioid Requirements (Fentanyl in micrograms) | The total amount of opioid (fentanyl in microgram) administered during surgery. The goal is to evaluate the opioid consumption required to maintain adequate analgesia during the procedure. | Throughout the duration of surgery. |
| Intraoperative Inhalational Anaesthetic (Isoflurane in ml/hour) Agent Requirements | Description: The total consumption of inhalational anesthetic agents (Isoflurane in ml/hour) during the surgical procedure. This measure will help assess the inhalational anaesthetic requirement between groups. | Throughout the duration of surgery |
| Intraoperative Muscle Relaxant (vecuronium in mg) Requirements | The total dose of muscle relaxant (vecuronium, in mg) is administered to maintain muscle relaxation during surgery. This will be compared between the two groups. | Throughout the duration of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative heart rate (HR) | Recorded at 15-minute intervals during the surgery | |
| Intraoperative Systolic Blood Pressure (mmHg) | Recorded at 15-minute intervals during the surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AKM Akhtaruzzaman, MD | Bangladesh Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangladesh Medical University | Dhaka | 1000 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34893026 | Background | Zhang S, Han X, Zhou D, Sun M, Cang J, Miao C, Liang C. The effects of erector spinae plane block on perioperative opioid consumption and rehabilitation in video assisted thoracic surgery. BMC Anesthesiol. 2021 Dec 10;21(1):313. doi: 10.1186/s12871-021-01536-x. | |
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| Related Info | View source |
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| Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block | Procedure | Description: Patients will receive general anesthesia in combination with an ultrasound-guided erector spinae plane (ESP) block. The ESP block will be performed at the L3-L5 vertebral level using a 22-gauge needle, with 20 mL of 0.25% bupivacaine and 5 mg dexamethasone administered bilaterally under sterile conditions. |
|
| Intraoperative diastolic blood pressure (mmHg) |
| Recorded at 15-minute intervals during the surgery |
| Intraoperative Mean Arterial Pressure (mmHg) | Recorded at 15-minute intervals during the surgery |
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| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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