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Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy

Primary Purpose

Post Operative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Quadratus lumborum block
Sponsored by
Petrovsky National Research Centre of Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

NRS (Numeric rating scale)
NRS scale 0-10, "no pain"; 10, "worst pain imaginable"

Secondary Outcome Measures

The need for opioid analgesics during surgery
The need for opioid analgesics for postoperative pain relief
The need for antiemetic drugs to relieve postoperative nausea and vomiting
Occurrence of prolonged post-operative ileus
Blood glucose level
The level of blood lactate
The level of cortisol in the blood
The level of prolactin in the blood

Full Information

First Posted
March 12, 2021
Last Updated
June 16, 2021
Sponsor
Petrovsky National Research Centre of Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT04848363
Brief Title
Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy
Official Title
Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Petrovsky National Research Centre of Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Quadratus lumborum block
Intervention Description
QL block will be used for perioperative anesthesia. The blockade will be performed bilaterally by levobupivacaine (20ml) at concentration 0.25%.
Primary Outcome Measure Information:
Title
NRS (Numeric rating scale)
Description
NRS scale 0-10, "no pain"; 10, "worst pain imaginable"
Time Frame
two hours after surgery
Secondary Outcome Measure Information:
Title
The need for opioid analgesics during surgery
Time Frame
on operations
Title
The need for opioid analgesics for postoperative pain relief
Time Frame
72 hours after surgery
Title
The need for antiemetic drugs to relieve postoperative nausea and vomiting
Time Frame
12 hours after the surgery
Title
Occurrence of prolonged post-operative ileus
Time Frame
first two weeks after surgery
Title
Blood glucose level
Time Frame
after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery
Title
The level of blood lactate
Time Frame
after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery
Title
The level of cortisol in the blood
Time Frame
after induction into anesthesia and immediately after the end of the surgery
Title
The level of prolactin in the blood
Time Frame
after induction into anesthesia and immediately after the end of the surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evgenii Bespalov
Phone
+79854633843
Email
evgenbespalovv@yandex.ru
Facility Information:
Facility Name
Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgenii Bespalov
Phone
+79854633843
Email
evgenbespalovv@yandex.ru

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All patient data will be confidential

Learn more about this trial

Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy

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