NCT05820620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

March 27, 2023

Last Update Submit

February 20, 2024

Conditions

Keywords

Morbid ObesityTAP BlockQLB blockAnalgesia

Outcome Measures

Primary Outcomes (2)

  • 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

  • Pain management

    Morphine consumption

    24th hours after surgery

Secondary Outcomes (1)

  • Patient Satisfaction

    Preoperative and after 7 days

Study Arms (3)

Control group

PLACEBO COMPARATOR

No intervention + Patient Control Analgesia (PCA)

Other: Control Group

QLB group

EXPERIMENTAL

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

Procedure: QLB block

TAP group

EXPERIMENTAL

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

Procedure: TAP block

Interventions

TAP blockPROCEDURE

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.

Also known as: Transversus abdominis plane (TAP)
TAP group
QLB blockPROCEDURE

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.

Also known as: Quadratus lumborum block (QLB)
QLB group

Control Group + Patient Control Analgesia (PCA)

Control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Suna Koç

Istanbul, Besyol, 34295, Turkey (Türkiye)

Location

Suna Koç

Istanbul, Kucukcekmece, 34295, Turkey (Türkiye)

Location

Related 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

    RESULT
  • 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

    RESULT
  • 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.

  • 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.

  • 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.

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

    RESULT
  • 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.

MeSH Terms

Conditions

Pain, PostoperativeObesity, MorbidAgnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Mehmet I Buget, Assoc Prof

    Biruni Universty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor Dr

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 19, 2023

Study Start

April 20, 2023

Primary Completion

February 20, 2024

Study Completion

February 21, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations