The study is planned as a single-center prospective randomized study and includes patients undergoing laparoscopic cholecystectomy. The aim of this study is to compare postoperative analgesic efficacy of erector spinae plane block and thoracic paravertebral block. Primary outcome is 24-hour postoperative opioid consumption.
All patients in the operating room receive the same anesthetic management under standard monitoring modalities. Both erector spinae plane block (ESPB) and thoracic paravertebral block (TPVB) are performed under ultrasound guidance at the T8 level using a linear probe and a longitudinal out-of-plane technique before induction of anesthesia. For ESPB, 10 mL of 0.375% bupivacaine is injected bilaterally between the deep fascia of the erector spinae muscle and the transverse process. For TPVB, 10 mL of 0.375% bupivacaine is injected bilaterally into the paravertebral space. After standard anesthesia induction, anesthesia is maintained with inhalation agents. Four milligrams of dexamethasone and 8 mg of ondansetron are administered for postoperative nausea and vomiting prophylaxis. As part of multimodal analgesia, all patients receive 1 g of paracetamol and 20 mg of tenoxicam. All patients are followed according to a standardized postoperative analgesia protocol, which includes tramadol patient-controlled analgesia (10 mg bolus, 20-minute lockout). Postoperative static and dynamic pain scores are evaluated using the numeric rating scale (NRS) at 0, 1, 4, 6, 12, 18, and 24 hours. If the NRS score is greater than 3, 0.5 mg/kg meperidine is administered as rescue analgesia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
10 mL of 0.375% bupivacaine is injected on each side between the deep fascia of the erector spinae muscle and the transverse process. Additionally, tramadol is administered via intravenous patient-controlled analgesia.
10 mL of 0.375% bupivacaine is injected on each side between the superior costotransverse ligament and the pleura.
Tramadol is administered via intravenous patient-controlled analgesia.
Istanbul University, Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye)
Tramadol consumption
amount of postoperative 24-hour tramadol consumption
Time frame: postoperative 24 hours
Amount of fentanyl
Amount of fentanyl used intraoperatively
Time frame: during surgery
Static and dynamic pain score
Static and dynamic pain scores are assessed with numeric rating scale at 0., 1., 4., 6., 12., 18. and 24. hours.
Time frame: postoperative 24 hours
First rescue analgesic time
The first time patient required rescue analgesic.
Time frame: postoperative 24 hours
Number of patients required rescue analgesic.
If the NRS score is greater than 3, 0.5 mg/kg meperidine is administered as rescue analgesia.
Time frame: postoperative 24 hours
Nausea and vomiting
Number of patients experienced postoperative nausea and vomiting
Time frame: postoperative 24 hours
Complications
Number of patients experienced complications postoperatively
Time frame: postoperative 24 hours
Quality of recovery
Patient recovery quality is evaluated using the Quality of Recovery-15 (QoR-15) questionnaire. QoR-15 scores range from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery).
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Time frame: postoperative 24 hours
Length of hospital stay
Length of hospital stay
Time frame: up to 1 week