NCT05950568

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 24, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 10, 2023

Last Update Submit

July 22, 2023

Conditions

Cesarean SectionQuadratus Lumborum BlockTransversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Time of the first analgesic request

    24 hour postoperatively

  • Patient satisfaction

    24 hour postoperatively

  • The degree of postoperative pain

    24 hour postoperatively

Study Arms (3)

Quadratus lumborum block type II

ACTIVE COMPARATOR

A 22 gauge needle was positioned between the erector spinae muscle in the thoracolumbar fascia's middle layer

Procedure: Quadratus lumborum block typen II

Quadratus lumborum block type III

ACTIVE COMPARATOR

A 22 gauge needle was positioned between the psoas and quadratus lumborum muscles at the anterior fascia lumbosacral

Procedure: Quadratus lumborum block III

Transversus abdominis plane block

ACTIVE COMPARATOR

A 22 gauge needle was positioned between the internal oblique and transversus abdominis muscles

Procedure: Transversus abdominis plane block

Interventions

Quadratus lumborum block typen IIPROCEDURE

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

Quadratus lumborum block type II
Quadratus lumborum block IIIPROCEDURE

A 22 gauge needle was positioned between the psoas and quadratus lumborum muscles at the anterior fascia lumbosacral

Quadratus lumborum block type III
Transversus abdominis plane blockPROCEDURE

A 22 gauge needle was positioned between the internal oblique and transversus abdominis muscles

Transversus abdominis plane block

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The General Authority for Teaching Hospitals and Institutes

Cairo, 11511, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of obstetrics and gynecology

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 18, 2023

Study Start

March 24, 2023

Primary Completion

June 25, 2023

Study Completion

June 25, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
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

Locations

EG(1)