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Pain, PostoperativeNCT05820620

Comparison of QLB Block and TAP Block in Morbid Obese Patients

A study testing TAP block and QLB block in people with Pain, Postoperative, run by Biruni University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Postoperative
What is being tested?
TAP block and QLB block
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
2 sitesTurkey (Türkiye)
Study dates
20 Apr 2023to 21 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Suna Koç

    Istanbul, Besyol, 34295

  • Suna Koç

    Istanbul, Kucukcekmece, 34295

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
TAP block, QLB block, Control Group
Keywords
Morbid Obesity, TAP Block, QLB block, Analgesia
Medical subject headings
Pain, Postoperative, Obesity, Morbid, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAP blockProcedure or surgery

    Also called Transversus abdominis plane (TAP)

    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 blockProcedure or surgery

    Also called Quadratus lumborum block (QLB)

    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.

  • Control GroupOther

    Control Group + Patient Control Analgesia (PCA)

Study groups in NCT05820620
Study groupRoleWhat they receive
Control groupPlacebo comparatorNo intervention + Patient Control Analgesia (PCA)
Receives: Other: Control Group
QLB groupExperimentalQLB group Block will be applied + Patient Control Analgesia (PCA)
Receives: Procedure: QLB block
TAP groupExperimentalTAP Block group will be applied + Patient Control Analgesia (PCA)
Receives: Procedure: TAP block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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')

    Measured: 24th hours after surgery

  2. Pain management

    Morphine consumption

    Measured: 24th hours after surgery

Secondary outcomes (1)
  1. Patient Satisfaction

    WHOQOL-BREF Quality of Life Assessment

    Measured: Preoperative and after 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2023
  2. Study start20 Apr 2023
  3. Primary completion20 Feb 2024
  4. Study completion21 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05820620
Sponsor's protocol ID
2015-KAEK-76-23-02
Status last verified
Feb 2024
First submitted
27 Mar 2023
Last updated
21 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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

  • 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.

    PubMed 21823370
  • 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.

    PubMed 10422935
  • 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.

    PubMed 19561014
  • 6. Bisgaard T (2006) Laparoskopik kolesistektomi sonrası 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-Blinded Controlled Trial. Obes Surg. 2019 May;29(5):1534-1541. doi: 10.1007/s11695-019-03720-y.

    PubMed 30706309

Questions about this trial

What is this clinical trial studying?

A study testing TAP block and QLB block in people with Pain, Postoperative, run by Biruni University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain management (time frame: 24th hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05820620, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.

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Clinical Trial NCT05820620 | AzTrials