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Comparison of QLB Block and TAP Block in Morbid Obese Patients

Primary Purpose

Pain, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TAP block
QLB block
Control Group
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Morbid Obesity, TAP Block, QLB block, Analgesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: BMI> 35 kg/m2 Laparoscopic sleeve gastrectomy operation ASA I-III General anesthesia will be applied and patients who agree to participate in the study will be included. Exclusion Criteria: Patients younger than 18 years of age Bleeding disorders (INR: 1.2, antithrombotic, antiaggregant drug use, hematological disorders, etc.) That are contraindications for regional anesthesia, and those with infection at the planned skin site Psychiatric or neurological disorders, and substance addictions

Sites / Locations

  • Suna KoçRecruiting
  • Suna KoçRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Control group

QLB group

TAP group

Arm Description

No intervention + Patient Control Analgesia (PCA)

QLB group Block will be applied + Patient Control Analgesia (PCA)

TAP Block group will be applied + Patient Control Analgesia (PCA)

Outcomes

Primary Outcome Measures

Pain management
VAS value (Visual Analogue Scale) : 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Pain management
Morphine consumption

Secondary Outcome Measures

Patient Satisfaction
WHOQOL-BREF Quality of Life Assessment

Full Information

First Posted
March 27, 2023
Last Updated
April 19, 2023
Sponsor
Biruni University
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1. Study Identification

Unique Protocol Identification Number
NCT05820620
Brief Title
Comparison of QLB Block and TAP Block in Morbid Obese Patients
Official Title
Comparison of QLB Block and TAP Block in Terms of Pain Management and Patient Satisfaction in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Quadratus lumborum block (QLB) and Transversus abdominis plane (TAP) blocks are regional anesthesia techniques that are frequently used to reduce postoperative pain and are an important part of the current analgesic regimen for many abdominal surgeries. In our clinic, researchers perform both blocks to provide postoperative analgesia. The primary aim of our study is to compare the effectiveness of TAP block and QLB block in postoperative pain control in laparoscopic sleeve gastrectomy. Secondary outcomes evaluated in this study were to assess postoperative nausea and vomiting (PONV), time to discharge, and patient satisfaction.
Detailed Description
As the number of obese patients increases, the number of surgeries performed for morbid-obese is also increasing. Pain following bariatric surgery is highly troubling and can lead to increased complication rate, decreased patient satisfaction rate, and prolonging the healing process, increasing the risk of pulmonary complications and the incidence of deep vein thrombosis. Since postoperative recovery is directly related to the severity and duration of pain, it is imperative to reduce postoperative pain as early as possible. Many post-operative methods have been suggested for patients undergoing laparoscopic surgery. Transversus abdominis plane (TAP) block is a regional anesthesia technique routinely used to reduce postoperative pain. Quadratus lumborum block (QLB) and Transversus abdominis plane (TAP) blocks are regional anesthesia techniques that are frequently used to reduce postoperative pain and are an important part of the current analgesic regimen for many abdominal surgeries. Researchers are doing these two blocks in our clinic to provide postoperative analgesia. The aim of our study is to compare the effectiveness of TAP block and QLB block in postoperative pain control in laparoscopic sleeve gastrectomy. Secondary outcomes evaluated in this study were to assess postoperative nausea and vomiting (PONV), time to discharge, and patient satisfaction. Many methods have been suggested to reduce postoperative abdominal wall pain, such as instillation of local anesthetics at the site of entry, patient-controlled analgesia (PCA), epidural catheterization, and the use of non-steroidal anti-inflammatory drugs (NSAIDS). It is known that opioid analgesics against acute postoperative pain cause postoperative nausea and vomiting (PONV) [3]. The mean incidence of PONV reported in the early postoperative period in patients undergoing bariatric surgery ranges from 30% to 50% [4]. Transversus abdominis plane (TAP) block is a routinely used regional anesthesia technique to reduce postoperative pain and is an important part of the current analgesic regimen for many abdominal surgeries [5]. A multimodal approach to pain management, with various combinations such as TAP blocks, local anesthetic infiltration and patient-controlled analgesia (PCA) has been suggested as the optimal combination for laparoscopic bariatric surgery [6]. Quadratus lumborum block (QLB) is one of the effective and routinely applied blocks in The primary aim of our study is to compare the effectiveness of TAP block and QLB block in postoperative pain control in laparoscopic sleeve gastrectomy. Secondary outcomes evaluated in this study were to assess postoperative nausea and vomiting (PONV), time to discharge, and patient satisfaction. Method Researchers planned to perform this study in a randomized controlled design in patients who will undergo laparoscopic sleeve gastrectomy in the operating room of Biruni University Hospital. After ethics committee approval, patients with BMI> 35 kg/m2, laparoscopic sleeve gastrectomy, ASA I-III, general anesthesia will be applied and patients who agree to participate in the study will be included. Patients younger than 18 years of age with bleeding disorders (INR: 1.2, antithrombotic, antiaggregant drug use, hematological disorders, etc.) that are contraindications for regional anesthesia, and those with infection at the planned skin site, psychiatric or neurological disorders, and substance addictions, will be excluded from the study. Randomization of patients will be provided through a computer program (software). After randomization, all patients will be brought to the operating room and then put to sleep with the general anesthesia method researchers apply daily. After the patients are routinely anesthesia administration TAP block will be applied to the 1st group, QLB block will be applied to the 2nd group, and no intervention will be performed to the 3rd group as it is the control group. Blocks will be performed with 0.25% bupivacaine under USG. PCA (patient controlled analgesia) will be administered to all patients in the postoperative period to provide analgesia. For rescue analgesia; If the VAS score of the patients reaches a level of >4 and above in the postoperative period, an additional 2mg IV bolus of morphine will be administered. In cases where it is not sufficient or it is needed again, it will be intervened again with 2 mg morphine until 4 <VAS VAS score (Preop -Post op 1., 6., 12 and 24 hours) and Patient Satisfaction (Preoperative and 48 hours) (World Health Organization) WHOQOL-BREF Quality of Life Assessment and analgesic consumption amount (Morphine consumption) as evaluation parameters of the patients : Post op 1st, 6th, 12th and 24th hours). It is planned to measure the effectiveness of the blocks by measuring the pain score and patient satisfaction in the preoperative and postoperative periods, and by measuring the amount of morphine consumed (in mg). In addition, it will be checked whether there is a change in discharge times between the groups in all patients. If complications such as postoperative nausea, vomiting, allergies, nerve damage and bleeding develop, they will be recorded. The required number of patients was determined by power analysis. In the calculation using the data of Emile et al., if 15% change is expected according to the 1st Hour VAS value of the TAP block [7]. Researchers plan a continuous study of response variables from matching study subject groups. Previous data show that the difference of matched pairs is normally distributed with a standard deviation of 1.3. If the true difference in the mean response of the matched pairs is 0.72, Researchers would need to study 28 subjects per group to reject the null hypothesis that this difference in response is zero with probability (power) 0.8. The probability of Type I error associated with this test of the 'null hypothesis' is 0.05. At least 84 patients for the three groups should be analyzed. Researchers plan to include 94 patients with a 10% probable dropout rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Morbid Obesity, TAP Block, QLB block, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After the patients are routinely put to sleep, TAP block will be applied to the 1st group, QLB block will be applied to the 2nd group, and no intervention will be performed to the 3rd group as it is the control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
No intervention + Patient Control Analgesia (PCA)
Arm Title
QLB group
Arm Type
Experimental
Arm Description
QLB group Block will be applied + Patient Control Analgesia (PCA)
Arm Title
TAP group
Arm Type
Experimental
Arm Description
TAP Block group will be applied + Patient Control Analgesia (PCA)
Intervention Type
Procedure
Intervention Name(s)
TAP block
Other Intervention Name(s)
Transversus abdominis plane (TAP)
Intervention Description
The transversus abdominis plane (TAP) block was introduced as a landmark-guided technique via the triangle of Petit to achieve a field block. It involves the injection of a local anesthetic solution into a plane between the internal oblique muscle and transversus abdominis muscle.
Intervention Type
Procedure
Intervention Name(s)
QLB block
Other Intervention Name(s)
Quadratus lumborum block (QLB)
Intervention Description
Quadratus lumborum block is a block of the posterior abdominal wall, "interfascial plane block," which is performed exclusively under ultrasound guidance. It was described as a variant of the TAP block.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Control Group + Patient Control Analgesia (PCA)
Primary Outcome Measure Information:
Title
Pain management
Description
VAS value (Visual Analogue Scale) : 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Time Frame
24th hours after surgery
Title
Pain management
Description
Morphine consumption
Time Frame
24th hours after surgery
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
WHOQOL-BREF Quality of Life Assessment
Time Frame
Preoperative and after 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI> 35 kg/m2 Laparoscopic sleeve gastrectomy operation ASA I-III General anesthesia will be applied and patients who agree to participate in the study will be included. Exclusion Criteria: Patients younger than 18 years of age Bleeding disorders (INR: 1.2, antithrombotic, antiaggregant drug use, hematological disorders, etc.) That are contraindications for regional anesthesia, and those with infection at the planned skin site Psychiatric or neurological disorders, and substance addictions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suna Koc
Phone
05055789802
Email
sunakoc@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet I Buget
Phone
05324133282
Email
mbuget@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet I Buget, Assoc Prof
Organizational Affiliation
Biruni Universty
Official's Role
Study Director
Facility Information:
Facility Name
Suna Koç
City
Istanbul
State/Province
Besyol
ZIP/Postal Code
34295
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suna Koc, MD
Email
sunakoc@yahoo.com
First Name & Middle Initial & Last Name & Degree
Suna Koc
Facility Name
Suna Koç
City
Istanbul
State/Province
Kucukcekmece
ZIP/Postal Code
34295
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suna Koç

12. IPD Sharing Statement

Citations:
Citation
1. Sarandan M, Balasa CG, Papurica M et al (2011) Anesthesia in laparoscopic bariatric surgery (gastric sleeve) preliminary experience. TMJ 61:1-2
Results Reference
result
Citation
2. Melzack R, Katz J (1994) Pain measurements in persons in pain. In Wall PD, Melzack R (Eds) Textbook of pain. Churchill Livingstone, Edinburgh, pp 409-426
Results Reference
result
PubMed Identifier
21823370
Citation
Macintyre PE, Loadsman JA, Scott DA. Opioids, ventilation and acute pain management. Anaesth Intensive Care. 2011 Jul;39(4):545-58. doi: 10.1177/0310057X1103900405.
Results Reference
result
PubMed Identifier
10422935
Citation
Sinclair DR, Chung F, Mezei G. Can postoperative nausea and vomiting be predicted? Anesthesiology. 1999 Jul;91(1):109-18. doi: 10.1097/00000542-199907000-00018.
Results Reference
result
PubMed Identifier
19561014
Citation
Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.
Results Reference
result
Citation
6. Bisgaard T (2006) Laparoskopik kolesistektomi sonrası analjezik tedavisi. Anesteziyoloji 104:835-846
Results Reference
result
PubMed Identifier
30706309
Citation
Emile SH, Abdel-Razik MA, Elbahrawy K, Elshobaky A, Shalaby M, Elbaz SA, Gado WA, Elbanna HG. Impact of Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Pain and Early Outcome After Laparoscopic Bariatric Surgery: a Randomized Double-Blinded Controlled Trial. Obes Surg. 2019 May;29(5):1534-1541. doi: 10.1007/s11695-019-03720-y.
Results Reference
result

Learn more about this trial

Comparison of QLB Block and TAP Block in Morbid Obese Patients

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