Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy

NCT ID: NCT04848363

Last Updated: 2021-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-16

Study Completion Date

2022-05-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Quadratus lumborum block

Intervention Type PROCEDURE

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

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.

Group Type PLACEBO_COMPARATOR

Quadratus lumborum block

Intervention Type PROCEDURE

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

Interventions

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Quadratus lumborum block

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Petrovsky National Research Centre of Surgery

OTHER

Sponsor Role lead

Responsible Party

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Evgenii Bespalov,MD

Doctor of the department of anesthesiology and resuscitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Evgenii Bespalov

Role: CONTACT

+79854633843

Facility Contacts

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Evgenii Bespalov

Role: primary

+79854633843

Other Identifiers

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BEK25011994

Identifier Type: -

Identifier Source: org_study_id

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