Pain, Acute Postoperative
Conditions
Keywords
postoperative pain, erector spinal plane block, thoracic paravertebral block
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREESPB
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.
PROCEDURETPVB
10 mL of 0.375% bupivacaine is injected on each side between the superior costotransverse ligament and the pleura.
PROCEDUREIV
Tramadol is administered via intravenous patient-controlled analgesia.
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective cholecystectomy * Age \>18years * American Society of Anesthesiologists classification I-III
Exclusion criteria
* Presence of contraindications for using regional anesthesia ( not having patient approval, bleeding diathesis or use of anticoagulants, infection at the injection site, and allergy to local anesthetics) * Chronic analgesic use * Open cholecystectomy or conversion to open cholecystectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tramadol consumption | postoperative 24 hours | amount of postoperative 24-hour tramadol consumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of fentanyl | during surgery | Amount of fentanyl used intraoperatively |
| Static and dynamic pain score | postoperative 24 hours | Static and dynamic pain scores are assessed with numeric rating scale at 0., 1., 4., 6., 12., 18. and 24. hours. |
| First rescue analgesic time | postoperative 24 hours | The first time patient required rescue analgesic. |
| Number of patients required rescue analgesic. | postoperative 24 hours | If the NRS score is greater than 3, 0.5 mg/kg meperidine is administered as rescue analgesia. |
| Nausea and vomiting | postoperative 24 hours | Number of patients experienced postoperative nausea and vomiting |
| Complications | postoperative 24 hours | Number of patients experienced complications postoperatively |
| Length of hospital stay | up to 1 week | Length of hospital stay |
| Quality of recovery | postoperative 24 hours | 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). |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORÖzlem Turhan
Istanbul Faculty of Medicine
Outcome results
None listed