Analgesia, Postoperative, ESPB, Spondylolisthesis
Conditions
Keywords
anaesthetic drug requirement, lumber spondylolisthesis surgery, Erector Spinae Plane Block
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREControl Group: General Anesthesia Without Erector Spinae Plane Block
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.
PROCEDUREIntervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block
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.
Sponsors
Bangladesh Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Patient undergoing lumbar spondylolisthesis surgery. 2. Elective procedures. 3. Age between 18 to 64 years. 4. American Society of Anaesthesiologists (ASA) physical status 1 and 2.
Exclusion criteria
1. Patient refusal. 2. Body Mass Index (BMI) \>35 kg/m2 3. Coagulopathy or bleeding disorders. 4. Allergy to any of the study drugs. 5. Substance abuse or dependence or previous history of opioid addiction. 6. Patients with central nervous system disease, severe cardiovascular system disease, hepatic disease or renal disease. 7. Local infection or inflammation at the site of block placement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Opioid Requirements (Fentanyl in micrograms) | Throughout the duration of surgery. | 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. |
| Intraoperative Inhalational Anaesthetic (Isoflurane in ml/hour) Agent Requirements | Throughout the duration of surgery | 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. |
| Intraoperative Muscle Relaxant (vecuronium in mg) Requirements | Throughout the duration of surgery | 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. |
Secondary
| Measure | 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 |
| 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 |
Countries
Bangladesh
Contacts
STUDY_DIRECTORAKM Akhtaruzzaman, MD
Bangladesh Medical University
Outcome results
None listed