Quadratus Lumborum Block Type 2 Versus Posterior Transversus Abdominus Plane Block

Regional Block Clinical Trial

— quadratus  

Official title:

A Comparative Study Between Quadratus Lumborum Block Type 2 and Posterior Transversus Abdominus Plane Block for Analgesia After Cesarean Delivery Under Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773730
• Other study ID #: regional block
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: June 3, 2023

Study information

• Verified date: June 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This patient population are at risk of adverse effects secondary to inadequate pain management such as inadequate maternal bonding and late ambulation. Regional analgesia is preferred due to their opioid sparing effects and reduction in related adverse effects but the analgesia from these blocks is not known which one is superior to the other in the context of cesarean section

Description:

The aim of this study is to compare the effect of posterior transversus abdominus plane block and quadratus lumborum type 2 for cesarean delivery. The transversus abdominus plane(TAP) block provides sensory block from T6 to L1 for lower abdominal surgeries. Quadratous lumborum type 2 block, the injection is posterior to the quadratus lumborum muscle. This method has the advantage of a more superficial point of injection with better ultrasonographic resolution. Only one RCT was done in this context by Kalpana Verma and his colleagues comparing quadratus lumborum type 2 and posterior transversus abdominus plane block. That shows marked discrepancy with time to first analgesic request from the quadratus lumborum block in other abdominal surgeries

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 3, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status II parturient.
• Singleton pregnancies with a gestation of at least 37 weeks.
• Patients undergoing spinal anesthesia for cesarean deliveryvia a Pfannenstiel incision with exteriorization of the uterus.

Exclusion Criteria:

• Age < 19 or > 40 years.
• Height<150 cm, weight < 60 kg, body mass index (BMI) =35 kg/m2.
• Inability to comprehend or participatein pain scoring system.
• Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
• Hypersensitivity to any drugused in the study.
• Hypertensive disorders of pregnancy.
• Renal impairment or other contraindication to non-steroidal anti-inflammatory drugs.
• Significant cardiovascular, renal or hepatic abnormalities.
• Patients with history of opoid intake, drug abusers, psychiatric patients.

Related Conditions & MeSH terms

• Regional Block

Intervention

Procedure:
• Posterior transversus abdominus plane block
Twenty mL of bupivacaine 0.25% will be injected in the plane between the transverses abdominus muscle and the fascia deep to the internal oblique muscle on each side
• Quadratus lumborum block type 2
Twenty mL of bupivacaine 0.25% will be injected on the posterior surface of quadrates lumborum muscle on each side

Locations

Country	Name	City	State
Egypt	El Mansoura	El Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The analgesic duration	the time measured from finishing the block till the first request of analgesia by the patient	within 24 hours after the surgery
Secondary	Postoperative pain at rest	100 centimetres visual analog scale (VAS) for pain, where zero is equal to no pain and hundred indicates the worst possible pain	immediately and 1,2,3,4hour at postanesthesia care unit, then in the surgical ward at 6,8,10,12,18 and 24 h
Secondary	Postoperative pain on movement (attempted hip flexion) or coughing	100 centimetres visual analog scale (VAS) for pain, where zero is equal to no pain and hundred indicates the worst possible pain	immediately and 1,2,3,4hour at postanesthesia care unit, then in the surgical ward at 6,8,10,12,18 and 24 h
Secondary	Patient satisfaction	poor= 1, fair = 2, good = 3, excellent = 4	24 hours after surgery
Secondary	Heart rate	beat per minute	at 1st, 2nd, 3rd, 4th, 10th, 16th and 22nd hours postoperatively
Secondary	Non-invasive blood pressure	mmHg	at 1st, 2nd, 3rd, 4th, 10th, 16th and 22nd hours postoperatively
Secondary	Total postoperative analgesic consumption of of ketolac, paracetamol and fentanyl	Patients with visual analog scale more than 30 will receive 30 mg of intravenous ketolac in addition to 1gm paracetamol which will be repeated every 8 hours intravenous infusion of every 8 hours. Intravenous administration of fentanyl bolus doses of 0.5 µg per kg per dose will be given if the visual analog scale remains more than 30	within the first 24 hours after surgery
Secondary	Postoperative nausea and vomiting	0= none, 1= mild, 2= moderate and 3= sever	within 24 hours after surgery
Secondary	Postoperative lower limb weakness	reported by the patient during her first walk after surgery	within 24 hours after surgery