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Quadratus Lumborum Block Type III Versus Type II Versus Transversus Abdominis Plane Block in Cesarean Section

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ClinicalTrials.gov Identifier: NCT05950568
Recruitment Status : Completed
First Posted : July 18, 2023
Last Update Posted : July 25, 2023
Sponsor:
Information provided by (Responsible Party):
Abeer Ali Elshabacy, The General Authority for Teaching Hospitals and Institutes

Study Description
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Brief Summary:
Compare the type III and type II quadratus lumborum block (QLB) to transversus abdominis plane block (TAPB) regarding efficacy in CS

Condition or disease Intervention/treatment Phase
Cesarean Section Quadratus Lumborum Block Transversus Abdominis Plane Block Procedure: Quadratus lumborum block typen II Procedure: Quadratus lumborum block III Procedure: Transversus abdominis plane block Not Applicable

Detailed Description:

The transversus abdominis plane block (TAPB) is administered between the internal oblique muscle and the transversus abdominis muscle in the fascial plane, directly pointing to the somatic nerves T6-L1 that run in this plane. In addition, meta-analyses demonstrate that it is an effective analgesic for somatic pain and diminishes opiate intake. It has been reported that TAPB is an efficient analgesic approach following cesarean section .

The quadratus lumborum (QL) muscle block (QLB) is a fascial plane block as local anesthetic (LA) is introduced nearby to the QL muscle to numb the thoracolumbar nerves. QLB is categorized into four types according to drug administration location, I (lateral), II (posterior), III (anterior/transmuscular), and Intravenous, (intramuscular). QLB can effectively decrease both visceral and somatic pain by LA distribution to the thoracic paravertebral space (TPVS), as this block ensures effective pain control from the T7 to L1 dermatomes. QLB is one of the regional techniques that provides the greatest benefit in post-CS pain control, as it is progressively applied in obstetric anesthetic precise to improve analgesic results.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Quadratus Lumborum Block Type III Versus Type II Versus Transversus Abdominis Plane Block in Cesarean Section: A Randomized Controlled Multicenter Trial
Actual Study Start Date : March 24, 2023
Actual Primary Completion Date : June 25, 2023
Actual Study Completion Date : June 25, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Quadratus lumborum block type II
A 22 gauge needle was positioned between the erector spinae muscle in the thoracolumbar fascia's middle layer
 Procedure: Quadratus lumborum block typen II
A 22 gauge needle was positioned between the quadratus lumborum muscle posterior border and the erector spinae muscle in the thoracolumbar fascia's middle layer
Active Comparator: Quadratus lumborum block type III
A 22 gauge needle was positioned between the psoas and quadratus lumborum muscles at the anterior fascia lumbosacral
 Procedure: Quadratus lumborum block III
A 22 gauge needle was positioned between the psoas and quadratus lumborum muscles at the anterior fascia lumbosacral
Active Comparator: Transversus abdominis plane block
A 22 gauge needle was positioned between the internal oblique and transversus abdominis muscles
 Procedure: Transversus abdominis plane block
A 22 gauge needle was positioned between the internal oblique and transversus abdominis muscles


Outcome Measures
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Primary Outcome Measures :
  1. Total postoperative consumed pethidine [ Time Frame: 24 hour postoperatively ]
    Numerical rating scales (NRS) score was evaluated at Post Anesthesia Care Unit (PACU), 2, 4, 6, 8, 12, 18, and 24 hours as as 0 is no pain and 10 is the worst pain imaginable. If the NRS score remained ≥ 4, we provided a bolus pethidine (0.5 mg/kg intravenous) and repeatable after 30 minutes if NRS remains≥ 4.


Secondary Outcome Measures :
  1. Time of the first analgesic request [ Time Frame: 24 hour postoperatively ]
    If the Numerical rating scales (NRS) score remained ≥ 4, we provided a bolus pethidine (0.5 mg/kg intravenous).

  2. Patient satisfaction [ Time Frame: 24 hour postoperatively ]
    The level of patient satisfaction was graded on a 5-point Likert scale as 0= extremely dissatisfied, 1= dissatisfied, 2= neither satisfied nor dissatisfied, 3= satisfied, 4= extremely satisfied

  3. The degree of postoperative pain [ Time Frame: 24 hour postoperatively ]
    Numerical rating scales (NRS ) score was evaluated at Post Anesthesia Care Unit (PACU), 2, 4, 6, 8, 12, 18, and 24 hours as as 0 is no pain and 10 is the worst pain imaginable.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status II
  • aged 18 to 40 years old
  • presenting for elective Cesarean section

Exclusion Criteria:

  • body mass index (BMI) ≥40 kg/m2
  • weight < 50kg
  • height < 150 cm
  • contraindications for the use of active labor, spinal anesthesia
  • recent opiate intake
  • hypersensitivity to any used medication
  • substantial cardiovascular diseases
  • renal diseases
  • hepatic, diseases.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05950568


Locations
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Egypt
The General Authority for Teaching Hospitals and Institutes
Cairo, Egypt, 11511
Sponsors and Collaborators
The General Authority for Teaching Hospitals and Institutes
More Information
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Responsible Party: Abeer Ali Elshabacy, Consultant of obstetrics and gynecology, The General Authority for Teaching Hospitals and Institutes
ClinicalTrials.gov Identifier: NCT05950568    
Other Study ID Numbers: HB000132
First Posted: July 18, 2023    Key Record Dates
Last Update Posted: July 25, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting Materials: Study Protocol
Time Frame: after the end of study for one year
Access Criteria: The data will be available upon a reasonable request from the corresponding author

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No