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Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Cesarean Section

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ClinicalTrials.gov Identifier: NCT02489851
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
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.


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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Post Cesarean Section Analgesia. A Randomised Controlled Study
Study Start Date : June 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Quadratus Lumborum block group

Quadratus Lumborum block group (QL)

patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%

Procedure: Quadratus Lumborum block
0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle
Other Name: QLB

Active Comparator: Transversus abdominis plane block group

Transversus abdominis plane block (TAP)

patients will receive a bilateral TAP block using Bupivicaine 0.125%

Procedure: Tranversus Abdominis plane block
0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.
Other Name: TAP




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. 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

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

  3. Sedation score [ Time Frame: 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.



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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): NCT02489851


Locations
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United Arab Emirates
Corniche Hospital
Abu Dhabi, United Arab Emirates, 3788
Sponsors and Collaborators
Corniche Hospital
Investigators
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Principal Investigator: Rafa Blanco, FRCA Corniche Hospital
Principal Investigator: Tarek Ansari, FFARCSI Corniche Hospital
Principal Investigator: Nanda Shetty, MD Corniche Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Corniche Hospital
ClinicalTrials.gov Identifier: NCT02489851    
Other Study ID Numbers: Ch23031404
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations