Post Operative Pain
Conditions
Brief summary
Comparison of the effectiveness: Quadratus lumborum (QL) block by levobupivacaine with placebo.
Detailed description
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.
Interventions
PROCEDUREQuadratus lumborum block
QL block will be used for perioperative anesthesia. The blockade will be performed bilaterally by levobupivacaine (20ml) at concentration 0.25%.
Sponsors
Petrovsky National Research Centre of Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
Distribution: randomized Intervention model: parallel distribution 2 groups * Control group: 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. Before surgery will be performde bilateral blockade of the QL muscle with normal saline. * Study group: 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. The QL blockade will be performed under ultrasound guidance using 20 ml of a solution of levobupivacaine 2.5 mg / ml.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have undergone left-sided or right-sided laparoscopic hemicolectomy. * Patient's willingness and ability to sign an informed consent document
Exclusion criteria
* Allergy to local anesthetics * Chronic pain syndrome and associated opioid use. * Coagulopathy * Uncontrolled diabetes mellitus * Physical Status Classification System scale above 3 * Diseases associated with the pathology of the hypothalamus * Diseases associated with the pathology of the pituitary gland * Diseases associated with the pathology of the adrenal glands
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS (Numeric rating scale) | two hours after surgery | NRS scale 0-10, no pain; 10, worst pain imaginable |
Secondary
| Measure | Time frame |
|---|---|
| The need for opioid analgesics for postoperative pain relief | 72 hours after surgery |
| The need for antiemetic drugs to relieve postoperative nausea and vomiting | 12 hours after the surgery |
| Occurrence of prolonged post-operative ileus | first two weeks after surgery |
| The need for opioid analgesics during surgery | on operations |
| 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. |
| Blood glucose level | after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery |
Countries
Russia
Contacts
Primary ContactEvgenii Bespalov
Outcome results
None listed