Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy

Comparison of the effectiveness: Quadratus lumborum (QL) block by levobupivacaine with placebo.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Procedure: Quadratus lumborum block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evgenii Bespalov; Phone Number: +79854633843; Email: evgenbespalovv@yandex.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Recruiting
    • Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)
    • Contact: Evgenii Bespalov; Phone Number: +79854633843; Email: evgenbespalovv@yandex.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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. 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.	Procedure: Quadratus lumborum block; QL block will be used for perioperative anesthesia. The blockade will be performed bilaterally by levobupivacaine (20ml) at concentration 0.25%.
Placebo Comparator: 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. 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.	Procedure: Quadratus lumborum block; QL block will be used for perioperative anesthesia. The blockade will be performed bilaterally by levobupivacaine (20ml) at concentration 0.25%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS (Numeric rating scale)	NRS scale 0-10, "no pain"; 10, "worst pain imaginable"	two hours after surgery

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Petrovsky National Research Centre of Surgery

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: BEK25011994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: All patient data will be confidential

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No