Comparison of QLB Block and TAP Block in Morbid Obese Patients

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05820620
• Other study ID #: 2015-KAEK-76-23-02
• Status: Completed
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: February 21, 2024

Study information

• Verified date: February 2024
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 21, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• TAP block
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.
• QLB block
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.

Other:
• Control Group
Control Group + Patient Control Analgesia (PCA)

Locations

Country	Name	City	State
Turkey	Suna Koç	Istanbul	Besyol
Turkey	Suna Koç	Istanbul	Kucukcekmece

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

1. Sarandan M, Balasa CG, Papurica M et al (2011) Anesthesia in laparoscopic bariatric surgery (gastric sleeve) preliminary experience. TMJ 61:1-2

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

6. Bisgaard T (2006) Laparoskopik kolesistektomi sonrasi analjezik tedavisi. Anesteziyoloji 104:835-846

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-B — View 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. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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')	24th hours after surgery
Primary	Pain management	Morphine consumption	24th hours after surgery
Secondary	Patient Satisfaction	WHOQOL-BREF Quality of Life Assessment	Preoperative and after 7 days