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Quadratus Lumborum Block vs Erector Spinal Block for Post Abdomen Surgery Analgesia

Primary Purpose

Pain, Acute, Postoperative Pain, Anesthetics, Local

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Ropivacaine injection
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring Anesthetics, Local Anesthetics

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients requiring abdomen surgery
  • Patients of age 18 and over
  • BMI < 40
  • Patients who are expected to stay in-hospital overnight after surgery

Exclusion Criteria:

  • Patient refusal
  • Contraindications to paravertebral blocks: Infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, and tumor occupying the thoracic paravertebral space, coagulopathy, bleeding disorder or therapeutic anticoagulation
  • Known allergy to local anesthetics
  • Inability to provide informed consent
  • Inability to use a PCA due to languate or comprehension barriers
  • BMI >= 40
  • Any patient on opioids for greater than or equal to 3 months duration prior to surgery
  • Patients with chronic pain syndromes

Sites / Locations

  • Jagiellonian UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

QLB

ESP

Arm Description

Experimental: Quadratus Lumborum block group Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Ropivacaine 0.375%

Ultrasound-guided continuous ESP block with opioid PCA A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T7/T8 spinous process. A Contiplex Echo ultra 360 18G needle with 20G × 55 cm Contiplex Echo catheter will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.375% ropivacaine

Outcomes

Primary Outcome Measures

Total long acting opioid consumption in oxycodone equivalents
the total dosage of given drug

Secondary Outcome Measures

Pain scores will be recorded at intervals. The Numerical Rating Scale (NRS) is an 11-point scale where 0 is no pain and 10 is the worst pain imaginable.
The patients will be asked about level of pain every 2 hours
Incidence of postoperative nausea-vomiting; respiratory depression; itching; local anesthetic toxicity; catheter leakage and catheter migration; infection at catheter site
The patients will be asked about Incidence of postoperative nausea-vomiting; respiratory depression; itching; local anesthetic toxicity; catheter leakage and catheter migration; infection at catheter site.

Full Information

First Posted
June 2, 2022
Last Updated
June 5, 2023
Sponsor
Jagiellonian University
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1. Study Identification

Unique Protocol Identification Number
NCT05446727
Brief Title
Quadratus Lumborum Block vs Erector Spinal Block for Post Abdomen Surgery Analgesia
Official Title
Quadratus Lumborum Block Versus Erector Spinal Block - Comparison of the Effectiveness of the Analgesic Effect in Patients After Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 6, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Erector Spinal Block (ESP) is based on the deposition of the local anesthetic in the inter-fascial space between the dorsal extensor muscle and the intercostal muscles at the height of the transverse processes. The scope of the blockade covers the dorsal and ventral branches of the thoracic spinal nerves, but also in most cases the investigetors are able to obtain a wide distribution of the drug into the paravertebral space by "permeating" the local anesthetic through the fascial compartments. The clinical effect of the blockade is due to blocking the nerve structures of the paravertebral space (spinal nerve branches and the sympathetic trunk). The scope of the blockade, after its execution at the level of Th5, most often includes the segments from Th1 to L1. Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic prostatectomy has not been investigated before and it is the variant that will be discussed in our study.
Detailed Description
In abdomen surgery, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain), visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after labdomen surgery may predict development of chronic pain. Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Postoperative Pain, Anesthetics, Local
Keywords
Anesthetics, Local Anesthetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QLB
Arm Type
Experimental
Arm Description
Experimental: Quadratus Lumborum block group Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Ropivacaine 0.375%
Arm Title
ESP
Arm Type
Experimental
Arm Description
Ultrasound-guided continuous ESP block with opioid PCA A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T7/T8 spinous process. A Contiplex Echo ultra 360 18G needle with 20G × 55 cm Contiplex Echo catheter will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.375% ropivacaine
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Intervention Description
30ml of 0.375% ropivacaine
Primary Outcome Measure Information:
Title
Total long acting opioid consumption in oxycodone equivalents
Description
the total dosage of given drug
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Pain scores will be recorded at intervals. The Numerical Rating Scale (NRS) is an 11-point scale where 0 is no pain and 10 is the worst pain imaginable.
Description
The patients will be asked about level of pain every 2 hours
Time Frame
2 days
Title
Incidence of postoperative nausea-vomiting; respiratory depression; itching; local anesthetic toxicity; catheter leakage and catheter migration; infection at catheter site
Description
The patients will be asked about Incidence of postoperative nausea-vomiting; respiratory depression; itching; local anesthetic toxicity; catheter leakage and catheter migration; infection at catheter site.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients requiring abdomen surgery Patients of age 18 and over BMI < 40 Patients who are expected to stay in-hospital overnight after surgery Exclusion Criteria: Patient refusal Contraindications to paravertebral blocks: Infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, and tumor occupying the thoracic paravertebral space, coagulopathy, bleeding disorder or therapeutic anticoagulation Known allergy to local anesthetics Inability to provide informed consent Inability to use a PCA due to languate or comprehension barriers BMI >= 40 Any patient on opioids for greater than or equal to 3 months duration prior to surgery Patients with chronic pain syndromes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomasz Składzień, phd md
Phone
506602250
Ext
+48
Email
t.skladzien@interia.pl
Facility Information:
Facility Name
Jagiellonian University
City
Cracovia
State/Province
Maloposkie
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomasz Skladzien, phd md
Phone
506602250
Ext
+48
Email
t.skladzien@interia.pl

12. IPD Sharing Statement

Plan to Share IPD
No

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Quadratus Lumborum Block vs Erector Spinal Block for Post Abdomen Surgery Analgesia

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