Clinical trial NCT04848363: Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy
Official title: Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Petrovsky National Research Centre of Surgery
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: NRS (Numeric rating scale)
timeFrame: two hours after surgery
Secondary outcomes:
measure: The need for opioid analgesics during surgery
timeFrame: on operations
measure: The need for opioid analgesics for postoperative pain relief
timeFrame: 72 hours after surgery
measure: The need for antiemetic drugs to relieve postoperative nausea and vomiting
timeFrame: 12 hours after the surgery
measure: Occurrence of prolonged post-operative ileus
timeFrame: first two weeks after surgery
measure: Blood glucose level
timeFrame: after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery
measure: The level of blood lactate
timeFrame: after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery
measure: The level of cortisol in the blood
timeFrame: after induction into anesthesia and immediately after the end of the surgery
measure: The level of prolactin in the blood
timeFrame: after induction into anesthesia and immediately after the end of the surgery.
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)
Study officials:
References: