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

Sponsor

The General Authority for Teaching Hospitals and Institutes (Other)

Overall Status

Completed

CT.gov ID

NCT05950568

Collaborator

(none)

Enrollment

Location

Arms

3.1

Actual Duration (Months)

19.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 :

Mar 24, 2023

Actual Primary Completion Date :

Jun 25, 2023

Actual Study Completion Date :

Jun 25, 2023

Arms and Interventions

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

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

Primary Outcome Measures

Total postoperative consumed pethidine [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

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

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	The General Authority for Teaching Hospitals and Institutes	Cairo		Egypt	11511

Sponsors and Collaborators

The General Authority for Teaching Hospitals and Institutes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jul 18, 2023

Last Update Posted:

Jul 25, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 25, 2023