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Comparison of the effectiveness: Quadratus lumborum (QL) block by levobupivacaine with placebo.
All patients will receive standard anaesthesia using fentanyl, protocol, cisatracurium and sevoflurane. Prevention of nausea and vomiting is performing using Apfel score.
All patients will receive post operative multimodal analgesia using paracetamol, ketoprofen, tramadol, and trimeperidine if numerical rating scale > 3 The study assumes use of QL block by levobupivacaine.in comparison with placebo in order to demonstrate the effectiveness of QL block during the operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | patients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. In this group, after induction of anesthesia before the operation, bilateral blockade of the square dorsi muscle is performed under ultrasound guidance using 20 ml of a solution of levobupivacaine 2.5 mg / ml. |
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| Control group | Placebo Comparator | patients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. In this group, after induction of anesthesia before surgery, bilateral blockade of the square dorsi muscle is performed under ultrasound guidance using 20 ml of saline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadratus lumborum block | Procedure | QL block will be used for perioperative anesthesia. The blockade will be performed bilaterally by levobupivacaine (20ml) at concentration 0.25%. |
| Measure | Description | Time Frame |
|---|---|---|
| NRS (Numeric rating scale) | NRS scale 0-10, "no pain"; 10, "worst pain imaginable" | two hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The need for opioid analgesics during surgery | on operations | |
| The need for opioid analgesics for postoperative pain relief | 72 hours after surgery | |
| The need for antiemetic drugs to relieve postoperative nausea and vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evgenii Bespalov | Contact | +79854633843 | evgenbespalovv@yandex.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Petrovsky Research National Centre of Surgery ( Petrovsky NRCS) | Recruiting | Moscow | 119991 | Russia |
All patient data will be confidential
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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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Distribution: randomized Intervention model: parallel distribution 2 groups
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Triple blindness. The Principal Investigator performing the blockade knows the randomization group. The anesthesiologist, postoperative pain assessor, and study participant do not know the randomization group.
| 12 hours after the surgery |
| Occurrence of prolonged post-operative ileus | first two weeks after surgery |
| Blood glucose level | after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery |
| The level of blood lactate | after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery |
| The level of cortisol in the blood | after induction into anesthesia and immediately after the end of the surgery |
| The level of prolactin in the blood | after induction into anesthesia and immediately after the end of the surgery. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |