Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy

Post Operative Pain Clinical Trial

Official title:

Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04848363
• Other study ID #: BEK25011994
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: June 2021
• Source: Petrovsky National Research Centre of Surgery
• Contact: Evgenii Bespalov
• Phone: +79854633843
• Email: evgenbespalovv[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

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%.

Locations

Country	Name	City	State
Russian Federation	Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Petrovsky National Research Centre of Surgery

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS (Numeric rating scale)	NRS scale 0-10, "no pain"; 10, "worst pain imaginable"	two hours after surgery
Secondary	The need for opioid analgesics during surgery		on operations
Secondary	The need for opioid analgesics for postoperative pain relief		72 hours after surgery
Secondary	The need for antiemetic drugs to relieve postoperative nausea and vomiting		12 hours after the surgery
Secondary	Occurrence of prolonged post-operative ileus		first two weeks after surgery
Secondary	Blood glucose level		after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery
Secondary	The level of blood lactate		after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery
Secondary	The level of cortisol in the blood		after induction into anesthesia and immediately after the end of the surgery
Secondary	The level of prolactin in the blood		after induction into anesthesia and immediately after the end of the surgery.