Erector Spinae Plane Block, Laparoscopic Cholecystectomy, Plane Block
Conditions
Keywords
Erector Spinae Plane Block, exora block, laparoscopic cholecystectomy, patient-controlled analgesia, plane block
Brief summary
Patients undergoing laparoscopic cholecystectomy may experience moderate to severe postoperative pain. Effective postoperative analgesia enhances patient comfort and accelerates recovery. This study aims to compare the effects of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) blocks on postoperative pain management and analgesic consumption. The study is designed as a prospective, randomized, double-blind trial. Patients will be randomly assigned to groups, and both practitioners and evaluators will be blinded to group assignments. Our hypothesis is that the EXORA block will provide superior analgesia and require less analgesic consumption compared to the ESP block. The results will be assessed in terms of postoperative pain management, patient comfort, and additional analgesic requirements.
Interventions
PROCEDUREGroup ESP
Experienced anesthesiologists with at least five years of expertise in regional anesthesia will perform the blocks under ultrasound guidance. A 4.0-12.0 MHz linear ultrasound probe (Affiniti 50; Philips) will be used. The ESP block will be applied at the T8 level on the right side, using an in-plane approach, while the patient is in a sitting position. The probe will be placed 2-3 cm lateral to the vertebra in a sagittal position to visualize the erector spinae muscle and transverse processes. A 22G, 100 mm block needle (Stimuplex® Ultra, Braun, Germany) will be advanced in a craniocaudal direction. The correct needle position will be confirmed by injecting 0.5-1 mL of isotonic NaCl and observing the spread via hydrodissection. Finally, 0.3 mL/kg of 0.25% bupivacaine will be administered, ensuring cranial and caudal spread of the local anesthetic.
PROCEDUREGroup EXORA
Experienced anesthesiologists with at least five years of expertise in regional anesthesia will administer the blocks under ultrasound guidance. A 4.0-12.0 MHz linear ultrasound probe will be placed laterally to the xiphoid process on the parasternal line in a sagittal position. The probe will be moved craniocaudally to identify the 6th rib and further advanced caudally to locate the 8th rib. Once the rectus abdominis muscle and 8th costal cartilage are identified, a 22G, 100 mm block needle will be used to administer 0.3 mL/kg of 0.25% bupivacaine. The correct spread of the local anesthetic will be confirmed via ultrasound.
Sponsors
Kutahya City Hospital
Aycan KURTARANGİL DOĞAN
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Age between 18 and 65 years Undergoing elective laparoscopic cholecystectomy Classified as American Society of Anesthesiologists (ASA) physical status I to III Providing written informed consent
Exclusion criteria
Known allergy or hypersensitivity to local anesthetics Infection or skin lesions at the site of block application Emergency surgical procedures Refusal to participate in the study Uncontrolled arterial hypertension Uncontrolled diabetes mellitus Mental retardation Current use of antidepressant medications Presence of metabolic disorders Known bleeding diathesis Morbid obesity (Body Mass Index \> 40 kg/m²)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tramadol consumption | 12 and 24 hours | Total tramadol used in the first 12 and 24 hours postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Pain Assessment | 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery | Postoperative pain will be assessed using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate a worse outcome (more pain). Units on a scale (0-10) |
| Pinprick Sensory Block Test Results | 10 minutes, 20 minutes, and 30 minutes after the block, and 30 minutes after surgery | Sensory block efficacy will be evaluated using the pinprick test at specified time intervals. The presence or absence of sensory block will be recorded. Binary (Block present / Block absent) |
| Ramsay Sedation Scale (RSS) | Within 24 hours after surgery | Postoperative sedation will be assessed using the Ramsay Sedation Scale (RSS), which includes: 1. = Anxious, agitated, or restless 2. = Cooperative, oriented, and tranquil 3. = Responds to commands only 4. = Brisk response to auditory stimulus 5. = Sluggish response to auditory stimulus 6. = No response Higher scores indicate a deeper level of sedation. Units on a scale (1-6) |
| Additional Analgesic Consumption | Within 24 hours after surgery | The total amount of additional analgesics administered postoperatively will be recorded. Milligrams (mg) |
| Nausea and Vomiting Score (NVS) | Within 24 hours after surgery | Postoperative nausea and vomiting will be evaluated using the Nausea and Vomiting Scale (NVS), which includes: 1. = No nausea, 2. = Mild nausea, 3. = Severe nausea, 4. = Vomiting present. Higher scores indicate a worse outcome. Units on a scale (1-4) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total Antiemetic Consumption | Within 24 hours after surgery | The total amount of antiemetic medication administered within 24 hours postoperatively will be recorded. Milligrams (mg) |
Contacts
Primary ContactAycan Kurtarangil Doğan
Backup ContactAli Kaynak
Outcome results
None listed