Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Cesarean Section

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Quadratus Lumborum block; Procedure: Tranversus Abdominis plane block

• Registration Number: NCT02489851
• Lead Sponsor: Corniche Hospital

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-03
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2016-05-22
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadratus Lumborum block group	Quadratus Lumborum block	Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%
Transversus abdominis plane block group	Tranversus Abdominis plane block	Transversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.125%

Primary Outcome Measures

Name	Time	Method
Total morphine used in the first 48 hours after surgery	48 hours	Total cumulative morphine dose in mg used in the first 48 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Severity of postoperative pain via visual analogue pain scale (VAS)	48 hours	VAS range from 0 for no pain to 10 for worst pain imaginable
Nausea or vomiting	48 hours	0 = No Nausea; 1. = Mild Nausea.; 2. = Moderate; 3. = Severe Nausea or Vomiting
Sedation score	48 hours	1. = drowsy but responds to normal verbal communication.; 2. = asleep, but awakes with verbal communication.; 3. = asleep, awakens with mild physical stimulation.; 4. = asleep, unresponsive to mild physical stimulation.

Trial Locations

Locations (1)

Corniche Hospital; 🇦🇪 Abu Dhabi, United Arab Emirates