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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05950568
Other study ID # HB000132
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 24, 2023
Est. completion date June 25, 2023

Study information

Verified date July 2023
Source The General Authority for Teaching Hospitals and Institutes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 25, 2023
Est. primary completion date June 25, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
Quadratus lumborum block III
A 22 gauge needle was positioned between the psoas and quadratus lumborum muscles at the anterior fascia lumbosacral
Transversus abdominis plane block
A 22 gauge needle was positioned between the internal oblique and transversus abdominis muscles

Locations

Country Name City State
Egypt The General Authority for Teaching Hospitals and Institutes Cairo

Sponsors (1)

Lead Sponsor Collaborator
The General Authority for Teaching Hospitals and Institutes

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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