Clinical trial NCT04773730: Quadratus Lumborum Block Type 2 Versus Posterior Transversus Abdominus Plane Block
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Block
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients will be randomly allocated via sealed opaque envelop into 2 groups of 50 patients each; Posterior transversus abdominus block (TAP) group and Quadratus lumborum block type 2 is the second group (QLB)group
Primary purpose: PREVENTION

Brief 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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: The analgesic duration
timeFrame: within 24 hours after the surgery
Secondary outcomes:
measure: Postoperative pain at rest
timeFrame: immediately and 1,2,3,4hour at postanesthesia care unit, then in the surgical ward at 6,8,10,12,18 and 24 h
measure: Postoperative pain on movement (attempted hip flexion) or coughing
timeFrame: immediately and 1,2,3,4hour at postanesthesia care unit, then in the surgical ward at 6,8,10,12,18 and 24 h
measure: Patient satisfaction
timeFrame: 24 hours after surgery
measure: Heart rate
timeFrame: at 1st, 2nd, 3rd, 4th, 10th, 16th and 22nd hours postoperatively
measure: Non-invasive blood pressure
timeFrame: at 1st, 2nd, 3rd, 4th, 10th, 16th and 22nd hours postoperatively
measure: Total postoperative analgesic consumption of of ketolac, paracetamol and fentanyl
timeFrame: within the first 24 hours after surgery
measure: Postoperative nausea and vomiting
timeFrame: within 24 hours after surgery
measure: Postoperative lower limb weakness
timeFrame: within 24 hours after surgery
Other outcomes:
Locations:
city: El Mansoura
country: Egypt
facility: El Mansoura
Study officials:
affiliation: Faculty of Medicine - Mansoura University
name: Maha Ahmed Abozeid, MD
role: STUDY_DIRECTOR
References: