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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328378
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Tarek Ansari, 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 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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Quadratus Lumborum block Not Applicable

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Pain Relief After Cesarean Section: Is There a Role for the Quadratus Lumborum Block?
Study Start Date : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Quadratus Lumborum block group (QL)
patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%
Procedure: Quadratus Lumborum block
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.

Placebo Comparator: Control Group
patients will receive a bilateral placebo block
Procedure: Quadratus Lumborum block
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 Outcome Measures :
  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 Outcome Measures :
  1. Nausea or vomiting [ Time Frame: 48 hours ]

    Categorical assessment of nausea. 0 = No Nausea

    1. = Mild Nausea.
    2. = Moderate
    3. = Severe Nausea or Vomit

  2. Sedation score in the first 48 hours [ Time Frame: 48 hours ]

    Categorical assessment of sedation. 0 = wide awake

    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.

  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328378


Locations
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United Arab Emirates
Corniche Hospital
Abu Dhabi, United Arab Emirates, 3788
Sponsors and Collaborators
Dr. Tarek Ansari
Investigators
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Principal Investigator: Rafa Blanco, FRCA Corniche Hospital
Principal Investigator: Tarek Ansari, FFARCSI Corniche Hospital
Principal Investigator: Emad Girgis, MD Corniche Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Tarek Ansari, Consultant Anesthetist, Corniche Hospital
ClinicalTrials.gov Identifier: NCT02328378    
Other Study ID Numbers: Ch27021403
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations