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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: ESPB | Experimental | Erector spinal plane block |
|
| Group 2: TPVB | Experimental | Thoracic paravertebral block |
|
| Group 3: IV | Experimental | intravenous analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESPB | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tramadol consumption | amount of postoperative 24-hour tramadol consumption | postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of fentanyl | Amount of fentanyl used intraoperatively | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Özlem Turhan | Istanbul Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University, Istanbul Faculty of Medicine | Istanbul | 34093 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| TPVB | Procedure | 10 mL of 0.375% bupivacaine is injected on each side between the superior costotransverse ligament and the pleura. |
|
| IV | Procedure | Tramadol is administered via intravenous patient-controlled analgesia. |
|
| postoperative 24 hours |
| First rescue analgesic time | The first time patient required rescue analgesic. | 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. | postoperative 24 hours |
| Nausea and vomiting | Number of patients experienced postoperative nausea and vomiting | postoperative 24 hours |
| Complications | Number of patients experienced complications postoperatively | 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). | postoperative 24 hours |
| Length of hospital stay | Length of hospital stay | up to 1 week |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |