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

Efficacy of Quadratus Lumborum Block Type III Versus Type II Versus Transversus Abdominis Plane Block in Cesarean Section: A Randomized Controlled Multicenter Trial

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Quadratus Lumborum Block; Transversus Abdominis Plane Block
• Intervention / Treatment: Procedure: Quadratus lumborum block typen II; Procedure: Quadratus lumborum block III; Procedure: Transversus abdominis plane block

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • The General Authority for Teaching Hospitals and Institutes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total postoperative consumed pethidine	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.	24 hour postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of the first analgesic request	If the Numerical rating scales (NRS) score remained ≥ 4, we provided a bolus pethidine (0.5 mg/kg intravenous).	24 hour postoperatively
Patient satisfaction	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	24 hour postoperatively
The degree of postoperative pain	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.	24 hour postoperatively

Collaborators and Investigators

• Sponsor: The General Authority for Teaching Hospitals and Institutes

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2023
• Primary Completion (Actual): June 25, 2023
• Study Completion (Actual): June 25, 2023

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 22, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HB000132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: after the end of study for one year
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No