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NCT Number: NCT02489851

Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Cesarean Section

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Corniche Hospital

Abu Dhabi, 3788, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

quadratus lumborum block

Procedure

0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle

Other names: QLB

Tranversus Abdominis plane block

Procedure

0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.

Other names: TAP

Primary outcomes

  1. Total morphine used in the first 48 hours after surgery

    Time frame: 48 hours

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

Secondary outcomes

  1. Severity of postoperative pain via visual analogue pain scale (VAS)

    Time frame: 48 hours

    VAS range from 0 for no pain to 10 for worst pain imaginable

  2. Nausea or vomiting

    Time frame: 48 hours

    0 = No Nausea

    • = Mild Nausea.
    • = Moderate
    • = Severe Nausea or Vomiting

  3. Sedation score

    Time frame: 48 hours

    • = drowsy but responds to normal verbal communication.
    • = asleep, but awakes with verbal communication.
    • = asleep, awakens with mild physical stimulation.
    • = asleep, unresponsive to mild physical stimulation.

Sponsors and collaborators

Lead sponsor

Corniche Hospital

Other

Registry information

Official study title

Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Post Cesarean Section Analgesia. A Randomised Controlled Study

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 3, 2015
Registry last updated
May 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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