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Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Quadratus Lumborum Block II
Patient controlled intravenous analgesia
Quadratus Lumborum Block III
Patient controlled intravenous analgesia
Paravertebral Block
Patient controlled intravenous analgesia
Sponsored by
Gaziosmanpasa Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring paravertebral block, quadratus lumborum block, laparoscopic cholecystectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18-65 years, American Society of Anesthesiologists physical statusⅠ-II Exclusion Criteria: local anesthetic allergy Infection at the procedure site Body Mass Index >35 kg/m2 Anticoagulant use with bleeding disorder Chronic analgesia and opioid use with mental and psychiatric disorders

Sites / Locations

  • Gaziosmanpasa Resarch and Education HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Quadratus Lumborum Block II

Quadratus Lumborum Block III

Paravertebral Block

Arm Description

Quadratus Lumborum Block II

Quadratus Lumborum Block III

Paravertebral Block

Outcomes

Primary Outcome Measures

Total amount of tramadol use
The total tramadol use of the patients in 24 hours will be recorded.

Secondary Outcome Measures

Visual Analogue Scale values at 1st, 6th, 12th and 24th hours
Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.
Block onset time
In order to evaluate sensory block, dermatome involvement will be evaluated with ice between Thoracic 1 and Lumbar 5 levels. When the feeling of coldness disappears, dermatome involvement will be considered. The sensory block formation time with ice will be evaluated as the block onset time, the10th, 20th and 30th minute dermatome area involvement will be recorded.
intraoperative remifentanil consumption
The total remifentanil use to be used in the maintenance of 0.05-0.2 mcg/kg remifentanil will be recorded by titration according to the hemodynamic data of the intraoperative patients.
postoperative length of hospital stay
time to patient's discharge
side effects such as nausea, vomiting and shoulder pain
The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.

Full Information

First Posted
June 21, 2023
Last Updated
July 5, 2023
Sponsor
Gaziosmanpasa Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05943015
Brief Title
Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks
Official Title
Comparison of Postoperative Analgesic Efficacy of Quadratus Lumborum II, Quadratus Lumborum III and Paravertebral Blocks in Elective Laparoscopic Cholecystectomies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital

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
This trial is a prospective, randomized, single-center, single blinded-analysis trial, the objective of which is compare the postoperative analgesia efficacy of Quadratus lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective laparoscopic cholecystectomy.
Detailed Description
Laparoscopic approach in cholecystectomy surgery is frequently preferred because of its advantages in systemic complications, morbidity, mortality and hospital stay. Pain is one of the important causes of late discharge after surgery. Laparoscopic cholecystectomy surgery requires a multimodal analgesia approach because of its multiple pain components.Regional analgesia techniques are effective in reducing the side effects such as intraoperative opioid use, postoperative pain and nausea and vomiting. Quadratus lumborum block and paravertebral plane blocks are regional techniques performed for multimodal analgesia. The aim of this study is to determine an effective analgesia method by comparing the postoperative analgesic effectiveness of Quadratus Lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective laparoscopic cholecystectomy surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
paravertebral block, quadratus lumborum block, laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quadratus Lumborum Block II
Arm Type
Active Comparator
Arm Description
Quadratus Lumborum Block II
Arm Title
Quadratus Lumborum Block III
Arm Type
Active Comparator
Arm Description
Quadratus Lumborum Block III
Arm Title
Paravertebral Block
Arm Type
Active Comparator
Arm Description
Paravertebral Block
Intervention Type
Procedure
Intervention Name(s)
Quadratus Lumborum Block II
Intervention Description
Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the psoas major and the transverse process adjacent to the quadratus lumborum muscle, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle negative aspiration into the middle layer of the thoracolumbar fascia posterior to the quadratus lumborum muscle, then 0.5-1 ml of saline 20 ml of 0.25% bupivacaine will be injected after hydrodissection is observed. The same will be done to the other side.
Intervention Type
Drug
Intervention Name(s)
Patient controlled intravenous analgesia
Intervention Description
Afterward of the operation, patients will be treated with patient-controlled analgesia with intravenous tramadol, with 20 mg bolus 20 minutes lock time, 4-hour limit 100 mg and 24-hour limit 400 mg
Intervention Type
Procedure
Intervention Name(s)
Quadratus Lumborum Block III
Intervention Description
Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.
Intervention Type
Drug
Intervention Name(s)
Patient controlled intravenous analgesia
Intervention Description
Afterward of the operation, patients will be treated with patient-controlled analgesia with intravenous tramadol, with 20 mg bolus 20 minutes lock time, 4-hour limit 100 mg and 24-hour limit 400 mg
Intervention Type
Procedure
Intervention Name(s)
Paravertebral Block
Intervention Description
Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. The linear ultrasound probe is placed longitudinally at the T6 level, 2-2.5 cm lateral to the spinous processes. Transverse process, superior costotransverse ligament and pleura are visualized, 22 gauge 80 mm peripheral block needle is passed with in-plane technique, superior costotransverse ligament is passed, negative aspiration into the paravertebral space under the ligament, followed by 0.5-1 ml of saline and hydrodissection of the pleura, followed by 20 ml of 0.25% bupivacaine is injected.The same is done to the opposite side.
Intervention Type
Drug
Intervention Name(s)
Patient controlled intravenous analgesia
Intervention Description
Afterward of the operation, patients will be treated with patient-controlled analgesia with intravenous tramadol, with 20 mg bolus 20 minutes lock time, 4-hour limit 100 mg and 24-hour limit 400 mg
Primary Outcome Measure Information:
Title
Total amount of tramadol use
Description
The total tramadol use of the patients in 24 hours will be recorded.
Time Frame
within 24 hours after the surgery
Secondary Outcome Measure Information:
Title
Visual Analogue Scale values at 1st, 6th, 12th and 24th hours
Description
Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.
Time Frame
at 1st, 6th, 12th and 24th hours after the surgery
Title
Block onset time
Description
In order to evaluate sensory block, dermatome involvement will be evaluated with ice between Thoracic 1 and Lumbar 5 levels. When the feeling of coldness disappears, dermatome involvement will be considered. The sensory block formation time with ice will be evaluated as the block onset time, the10th, 20th and 30th minute dermatome area involvement will be recorded.
Time Frame
30 min after the block
Title
intraoperative remifentanil consumption
Description
The total remifentanil use to be used in the maintenance of 0.05-0.2 mcg/kg remifentanil will be recorded by titration according to the hemodynamic data of the intraoperative patients.
Time Frame
during operation procedure
Title
postoperative length of hospital stay
Description
time to patient's discharge
Time Frame
within 1 weeks after the surgery
Title
side effects such as nausea, vomiting and shoulder pain
Description
The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.
Time Frame
within 24 hours after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years, American Society of Anesthesiologists physical statusⅠ-II Exclusion Criteria: local anesthetic allergy Infection at the procedure site Body Mass Index >35 kg/m2 Anticoagulant use with bleeding disorder Chronic analgesia and opioid use with mental and psychiatric disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DONDU GENC MORALAR
Phone
+905053737913
Email
dondugencm@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
EMINE KOSE
Phone
+905422748184
Email
emine.kose.184@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMINE KOSE
Organizational Affiliation
Gaziosmanpasa Research and Education Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DONDU GENC MORALAR
Organizational Affiliation
Gaziosmanpasa Research and Education Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
SERPIL SAHIN SEHIRLIOGLU
Organizational Affiliation
Gaziosmanpasa Research and Education Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziosmanpasa Resarch and Education Hospital
City
Istanbul
ZIP/Postal Code
34255
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DONDU GENC MORALAR
Phone
+905053737913
Email
dondugencm@gmail.com
First Name & Middle Initial & Last Name & Degree
EMINE KOSE
First Name & Middle Initial & Last Name & Degree
DONDU GENC MORALAR
First Name & Middle Initial & Last Name & Degree
SERPIL SAHIN SEHIRLIOGLU

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36891030
Citation
Wang J, Cui X, Ren L, Li X, Zhang Y, Xie Y, Ji Z, Huang Y. Comparison of the Postoperative Analgesic Effects between Ultrasound-Guided Transmuscular Quadratus Lumborum Block and Thoracic Paravertebral Block in Laparoscopic Partial Nephrectomy Patients: A Randomized, Controlled, and Noninferiority Study. Pain Res Manag. 2023 Feb 20;2023:8652596. doi: 10.1155/2023/8652596. eCollection 2023.
Results Reference
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Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks

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