Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy

Not Applicable

• Conditions: Post Operative Pain

• Registration Number: NCT04848363
• Lead Sponsor: Petrovsky National Research Centre of Surgery

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.

Study Timeline

• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-19
• Status Verified: 2021-06
• Study Start: 2021-06-16
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-18
• Primary Completion: 2022-04-30
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
NRS (Numeric rating scale)	two hours after surgery	NRS scale 0-10, "no pain"; 10, "worst pain imaginable"

Secondary Outcome Measures

Name	Time	Method
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 for postoperative pain relief	72 hours after surgery
Blood glucose level	after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery
The need for opioid analgesics during surgery	on operations
The level of prolactin in the blood	after induction into anesthesia and immediately after the end of 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

Trial Locations

Locations (1)

Petrovsky Research National Centre of Surgery ( Petrovsky NRCS); 🇷🇺 Moscow, Russian Federation