Clinical trial NCT02489851: Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Cesarean Section
Official title: Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Post Cesarean Section Analgesia. A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Corniche Hospital
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread of the local anesthetic agents may produce extensive analgesia and prolonged action of the injected local anesthetic solution.

Previous studies showed that both TAP block and QLB may reduce morphine requirements in the postoperative period in patients who had cesarean section under spinal anaesthesia. However there are no published reports comparing the 2 techniques.

The aim of this randomised controlled, double blinded study is to compare the analgesic efficacy of QLB compared to TAP block in patients who had cesarean section under spinal anesthesia.

Detailed description: After ethical committee approval, informed written consent will be obtained from all patients. A Sample size of 72 patients (36 per group) was calculated based on 15% reduction in morphine consumption with 0.05% significance and a power of 0.8.

Consenting patients scheduled to have elective cesarean section under spinal anesthesia will be randomised to receive bilateral QLB or TAP at the end of surgery.The dose of local anaesthetic in both groups will be 0.2 ml/kg 0.125% Bupivacaine. Allocation to either group will be done using closed envelope technique.

All the blocks will be performed in operation theatre after the end of cesarean section with intravenous access, ECG, BP, oxygen saturation by pulse oximetry monitoring and full resuscitation equipment and medication ready.

All patients will be in the supine position . Under ultrasound guidance a 22 Gauge, two inch Pajunk Sonoplex needle will be used for both techniques. The calculated dose of local anaeshetic will be injected bilateraly with intermittent aspiration. The spread of injectate will be seed on ultrasound.

All patients will receive the routine postoperative analgesia, comprising patient-controlled IV morphine analgesia and regular diclofenac and paracetamol.

All patients will be assessed postoperatively by a blinded investigator: in the postanesthesia care unit and at 2, 4, 6, 12, 24, 36, and 48 h postoperatively.

Eligibility criteria: Inclusion Criteria:

Elective caesarean sections ASA 1 to 3 Written informed consent.

Exclusion Criteria:

Patient refusal Local infection at the site of injection Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy Inability to comprehend or participate in pain scoring system Inability to use intravenous patient controlled analgesia

Primary outcomes:
measure: Total morphine used in the first 48 hours after surgery
timeFrame: 48 hours
Secondary outcomes:
measure: Severity of postoperative pain via visual analogue pain scale (VAS)
timeFrame: 48 hours
measure: Nausea or vomiting
timeFrame: 48 hours
measure: Sedation score
timeFrame: 48 hours
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Corniche Hospital
Study officials:
affiliation: Corniche Hospital
name: Rafa Blanco, FRCA
role: PRINCIPAL_INVESTIGATOR
affiliation: Corniche Hospital
name: Tarek Ansari, FFARCSI
role: PRINCIPAL_INVESTIGATOR
affiliation: Corniche Hospital
name: Nanda Shetty, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.