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Comparison of Intrathecal Morphine With the Quadratus Lumborum Type 2 Block for Post-operative Analgesia Following Elective Caesarean Section (QLBvITM Study)

Primary Purpose

Cesarean Section, Pain, Acute

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intrathecal morphine as well as local anaesthetic in Blocks
Intrathecal morphine as well as saline in Block
Saline intrathecal as well as saline in Blocks
Saline intrathecal as well as local anaesthetic in Blocks
Sponsored by
Dr Willem Basson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cesarean Section focused on measuring intrathecal morphine, quadratus lumborum type 2 block, cesarean section, pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Anaesthetist trained in QLB and ITM techniques available
  • American Society of Anaesthesiologists PS category client I or II
  • 18 years of age or older
  • Ability to read and understand English
  • Uncomplicated pregnancy at term (>37 weeks completed gestation)
  • Booked elective CS

Exclusion Criteria:

  • Contraindications to spinal anaesthesia
  • History of chronic opioid consumption / chronic pain conditions
  • Known allergy to study drugs
  • Weight more than 95kg or body mass index (BMI) more than 35 pre operative
  • Placenta Previa / accreta
  • Obstructive Sleep apnoea
  • Severe asthma unable to tolerate Non steroidal anti inflammatory agents

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Sham Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Saline intrathecal as well as saline in Blocks

    Saline intrathecal as well as local anaesthetic in Blocks

    Intrathecal morphine as well as local anaesthetic in Blocks

    Intrathecal morphine as well as saline in Block

    Arm Description

    These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.

    These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.

    These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.

    These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.

    Outcomes

    Primary Outcome Measures

    24 hours total intravenous morphine usage via a PCA pump
    Post operative intravenous morphine use will be noted at 24 hours post cesarean section

    Secondary Outcome Measures

    Patient's side effects within the 24 hours post operative period.
    Nausea, vomiting, itching, herpes reactivation, urinary retention and sedation will be noted.
    Pain Scores within 24 hours post operative period.
    Using a VAS we will note both dynamic and static pain scores at 24 hours post operative

    Full Information

    First Posted
    August 10, 2017
    Last Updated
    April 15, 2019
    Sponsor
    Dr Willem Basson
    Collaborators
    Sunshine Coast Hospital and Health Service
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03267628
    Brief Title
    Comparison of Intrathecal Morphine With the Quadratus Lumborum Type 2 Block for Post-operative Analgesia Following Elective Caesarean Section (QLBvITM Study)
    Official Title
    Quadratus Lumborum Type 2 Block Versus Intrathecal Morphine for Analgesia Following Elective Caesarean Sections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    We at the Sunshine Coast University Hospital are unable to cope with the extra effort/time needed to complete this trial properly.
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    November 1, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr Willem Basson
    Collaborators
    Sunshine Coast Hospital and Health Service

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators are comparing post operative analgesia provided for caesarean section patients, with the quadratus lumborum type 2 block and intrathecal morphine.
    Detailed Description
    In Australia the rate of birth via caesarean section (CS) has significantly increased over the last twenty years. Improvements in the care of women undergoing CS are important locally, nationally and internationally. Compared to women birthing vaginally, women undergoing CS experience more adverse events and more pain. Effective pain relief following CS is important as it enables early ambulation, encourages maternal bonding, and promotes breastfeeding initiation and establishment. Traditional analgesic techniques following CS include opioid medications. Whist effective, the use of opioids are associated with frequent and significant side effects. Alternative analgesic agents are being explored in an attempt to improve the effectiveness of pain relief available to women and clinicians. The quadratus lumborum block (QLB) block is an innovative regional analgesic technique. Its role as an effective analgesic agent in abdominal surgery is increasing. However, it has not been studied for pain relief in Australia after cesarean section. In this study, the investigator aims to compare post-operative analgesia and side effects between the QLB blocks versus adding morphine the participant's spinal anaesthetic (ITM) during the elective C/S. Results from this study will provide information on the analgesic impact of this new and emerging therapy and assist in the development of a larger clinical trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cesarean Section, Pain, Acute
    Keywords
    intrathecal morphine, quadratus lumborum type 2 block, cesarean section, pain

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    4 groups of 25 patients each. All patients will receive a spinal and a quadratus lumborum type 2 block. The groups will have a combination of ITM / QLB or both or neither.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Double blinded
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Saline intrathecal as well as saline in Blocks
    Arm Type
    Sham Comparator
    Arm Description
    These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.
    Arm Title
    Saline intrathecal as well as local anaesthetic in Blocks
    Arm Type
    Active Comparator
    Arm Description
    These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.
    Arm Title
    Intrathecal morphine as well as local anaesthetic in Blocks
    Arm Type
    Active Comparator
    Arm Description
    These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.
    Arm Title
    Intrathecal morphine as well as saline in Block
    Arm Type
    Active Comparator
    Arm Description
    These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.
    Intervention Type
    Procedure
    Intervention Name(s)
    Intrathecal morphine as well as local anaesthetic in Blocks
    Intervention Description
    A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle. 150mcg morphine will be added to the spinal anaesthetic.
    Intervention Type
    Procedure
    Intervention Name(s)
    Intrathecal morphine as well as saline in Block
    Intervention Description
    150mcg morphine will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.
    Intervention Type
    Procedure
    Intervention Name(s)
    Saline intrathecal as well as saline in Blocks
    Intervention Description
    0.3 ml saline will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.
    Intervention Type
    Procedure
    Intervention Name(s)
    Saline intrathecal as well as local anaesthetic in Blocks
    Intervention Description
    0.3 ml saline will be added to the spinal anaesthetic. A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.
    Primary Outcome Measure Information:
    Title
    24 hours total intravenous morphine usage via a PCA pump
    Description
    Post operative intravenous morphine use will be noted at 24 hours post cesarean section
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Patient's side effects within the 24 hours post operative period.
    Description
    Nausea, vomiting, itching, herpes reactivation, urinary retention and sedation will be noted.
    Time Frame
    24 hours
    Title
    Pain Scores within 24 hours post operative period.
    Description
    Using a VAS we will note both dynamic and static pain scores at 24 hours post operative
    Time Frame
    24 hours

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female patients undergoing elective cesarean sections
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Anaesthetist trained in QLB and ITM techniques available American Society of Anaesthesiologists PS category client I or II 18 years of age or older Ability to read and understand English Uncomplicated pregnancy at term (>37 weeks completed gestation) Booked elective CS Exclusion Criteria: Contraindications to spinal anaesthesia History of chronic opioid consumption / chronic pain conditions Known allergy to study drugs Weight more than 95kg or body mass index (BMI) more than 35 pre operative Placenta Previa / accreta Obstructive Sleep apnoea Severe asthma unable to tolerate Non steroidal anti inflammatory agents
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Willem Basson, FANZCA
    Organizational Affiliation
    Sunshine Coast University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparison of Intrathecal Morphine With the Quadratus Lumborum Type 2 Block for Post-operative Analgesia Following Elective Caesarean Section (QLBvITM Study)

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