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Quadratus Lumborum Block for Postoperative Analgesia After Colostomy Closure

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
levo-bupivacaine
normal saline
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A physical status between ASA I and III
  • 20 - 75 years of age
  • Patient has signed an informed consent
  • Without contraindication of QL block

Exclusion Criteria

  • American Society of Anesthesiologists (ASA) Physical Status ≥ 4
  • Any contraindication to nerve blocks (including coagulopathy, abnormal anatomy, infection at the planned QL injection site, and amide-type local anesthetic allergy) pregnancy or breast-feeding
  • Severe obesity (body mass index≥ 35 kg/m2)
  • Patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease
  • Allergy to NSAIDs
  • Infection at the QL injection site
  • Patients with major psychosis or drug and alcohol abuse
  • Patient unable to comprehend or use the verbal rating pain scoring system or patient-controlled analgesia pump

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Active Comparator

    Arm Label

    Placebo QL block

    Active QL block

    Arm Description

    30 ml single shot QL block with saline 0.9%

    30 ml single shot QL block with 0.25% levo-bupivacaine

    Outcomes

    Primary Outcome Measures

    cumulative morphine consumption

    Secondary Outcome Measures

    Full Information

    First Posted
    February 17, 2016
    Last Updated
    February 21, 2016
    Sponsor
    Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02691403
    Brief Title
    Quadratus Lumborum Block for Postoperative Analgesia After Colostomy Closure
    Official Title
    Ultrasound-guided Quadratus Lumborum Block for Postoperative Analgesia After Colostomy: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    June 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-sen University

    4. Oversight

    5. Study Description

    Brief Summary
    Patients undergoing abdominal procedures often require multimodal postoperative pain controls. Truncal blocks such as quadratus lumborum (QL) block may be used adjunctively as a part of it. The investigators hypothesized that the ultrasound-guided QL block with transmuscular approach can provide adequate pain relief for colostomy closure as part of a multimodal pain control.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo QL block
    Arm Type
    Sham Comparator
    Arm Description
    30 ml single shot QL block with saline 0.9%
    Arm Title
    Active QL block
    Arm Type
    Active Comparator
    Arm Description
    30 ml single shot QL block with 0.25% levo-bupivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    levo-bupivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    normal saline
    Primary Outcome Measure Information:
    Title
    cumulative morphine consumption
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A physical status between ASA I and III 20 - 75 years of age Patient has signed an informed consent Without contraindication of QL block Exclusion Criteria American Society of Anesthesiologists (ASA) Physical Status ≥ 4 Any contraindication to nerve blocks (including coagulopathy, abnormal anatomy, infection at the planned QL injection site, and amide-type local anesthetic allergy) pregnancy or breast-feeding Severe obesity (body mass index≥ 35 kg/m2) Patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease Allergy to NSAIDs Infection at the QL injection site Patients with major psychosis or drug and alcohol abuse Patient unable to comprehend or use the verbal rating pain scoring system or patient-controlled analgesia pump

    12. IPD Sharing Statement

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    Quadratus Lumborum Block for Postoperative Analgesia After Colostomy Closure

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