Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy

NCT04848363 | Unknown

• 1 other identifier: BEK25011994
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• NRS (Numeric rating scale)

  NRS scale 0-10, "no pain"; 10, "worst pain imaginable"

  two hours after surgery

Secondary Outcomes (8)

• 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

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Quadratus lumborum block PROCEDURE

QL block will be used for perioperative anesthesia. The blockade will be performed bilaterally by levobupivacaine (20ml) at concentration 0.25%.

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have undergone left-sided or right-sided laparoscopic hemicolectomy.
• Patient's willingness and ability to sign an informed consent document

You may not qualify if:

• 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

Sponsors & Collaborators

• Petrovsky National Research Centre of Surgery: lead

Study Sites (1)

Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Evgenii Bespalov

CONTACT

+79854633843; evgenbespalovv@yandex.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of the department of anesthesiology and resuscitation

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: April 19, 2021
• Study Start: June 16, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 30, 2022
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)