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NCT Number: NCT02328378

Postoperative Pain Relief After Cesarean Section: Is There a Role for the Quadratus Lumborum Block?

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 produces extensive analgesia and prolonged action of the injected local anesthetic solution.

Previous studies showed that TAP block may not be effective in improving postoperative analgesia in patients who had cesarean section under spinal anaesthesia.

The aim of this randomised controlled, double blinded study is to examine the effect of QLB on the postoperative pain management 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 25 patients 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 undergo QLB with Bupivacaine versus placebo(saline) after their surgery. Allocation will be done using closed envelope technique.

The study medications/placebo will be prepared and labelled by an anesthetist who is not involved in the study.

All patients will receive a standard spinal anesthetic. At the end of surgery , Quadratus lumborum block group (QL) patients will receive bilateral QLB with 0.125% bupivacaine.

Control group patients will receive a bilateral placebo block using saline. The block 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.

The patient will be placed in a lateral position with the side to be blocked facing upwards. The ultrasound probe will be properly sterilized and with sterile covers.

A 22 Gauge, two inch Pajunk Sonoplex needle is advanced under ultrasound guidance on the posterior aspect of the Quadratus Lumborum. Following negative aspiration, 0.2 ml/kg of 0.125% bupivacaine, or placebo(saline) is injected in each side with intermittent aspiration and the spread of injectate followed 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

Patients will receive a bilateral Quadratus Lumborum block using 0.125% Bupivacaine in a dose of 0.2ml/kg body weight, after the end of surgery.

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. Nausea or vomiting

    Time frame: 48 hours

    Categorical assessment of nausea. 0 = No Nausea

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

  2. Sedation score in the first 48 hours

    Time frame: 48 hours

    Categorical assessment of sedation. 0 = wide awake

    • = 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.

  3. Severity of postoperative pain via visual analogue pain scale

    Time frame: 48 hours

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

Sponsors and collaborators

Lead sponsor

Dr. Tarek Ansari

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 31, 2014
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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