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Dexamethasone or Dexmedetomidine as Adjunct in Fascia Iliaca Block During Positioning for Sub-arachnoid Block & Post-operative Analgesia After Femur Neck Fracture Surgery: A Randomized Control Trial

Primary Purpose

Post Operative Pain

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexamethasone
Dexmedetomidine
Sponsored by
Aga Khan University Hospital, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age group (18-80)
  • Undergoing elective/emergency femur fracture repair under sub-arachnoid block
  • ASA status I-III

Exclusion Criteria:

  • Participation in any other trial
  • Known hypersensitivity to study medications
  • Seizure disorder
  • Coagulation disorder
  • Infection over injection site
  • Hemodynamic Instability
  • Concurrent medications use that is contraindicated with study medications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Group A

    Group B

    Group C

    Arm Description

    Patients allocated to group A will receive ultrasound guided FICB with 0.375% ropivacaine 38 cc along with 8 mg dexamethasone in 2cc making a total injection volume of 40 cc.

    Patients allocated to group B will receive ultrasound guided FICB with 0.375% ropivacaine 38 cc along with 1 µg/kg dexmedetomidine in 2cc dilution making a total injection volume of 40 cc.

    Patients allocated to group C will receive ultrasound guided FICB with 0.375% ropivacaine 38 cc along with 2 cc normal saline making a total injection volume of 40 cc. This will serve as the control arm.

    Outcomes

    Primary Outcome Measures

    Pain score after fascia iliaca block placement
    Static pain will be recorded at 5 minute interval with the help of Numeric Rating Scale (NRS) of 0 to 10 (with 0 being no pain at all and 10 being worst imaginable pain).
    Pain score after fascia iliaca block placement
    Static pain will be recorded at 10-minute interval with the help of Numeric Rating Scale (NRS) of 0 to 10 (with 0 being no pain at all and 10 being worst imaginable pain).
    Pain score during positioning of patient for sub-arachnoid block
    After 15 minutes of fascia iliaca block placement, patients will be positioned for sub-arachnoid block. At this point, dynamic pain will be recorded with the help of Numeric Rating Scale (NRS) of 0 to 10 (with 0 being no pain at all and 10 being worst imaginable pain).

    Secondary Outcome Measures

    Duration of postoperative analgesia
    This will be measured by the demand to first rescue analgesic
    Post-operative Pain
    Post-operative pain will be assessed via the Numeric Rating Scale (NRS) of 0 to 10 (with 0 being no pain at all and 10 being worst imaginable pain).
    Post-operative Pain
    Post-operative pain will be assessed Numeric Rating Scale (NRS) of 0 to 10 (with 0 being no pain at all and 10 being worst imaginable pain).
    Post-operative Pain
    Post-operative pain will be assessed via the Numeric Rating Scale (NRS) of 0 to 10 (with 0 being no pain at all and 10 being worst imaginable pain).
    Post-operative Pain
    Post-operative pain will be assessed via the Numeric Rating Scale (NRS) of 0 to 10 (with 0 being no pain at all and 10 being worst imaginable pain).
    Patient Satisfaction
    Patient satisfaction would be assessed via the Likert Scale

    Full Information

    First Posted
    July 24, 2022
    Last Updated
    July 31, 2022
    Sponsor
    Aga Khan University Hospital, Pakistan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05484648
    Brief Title
    Dexamethasone or Dexmedetomidine as Adjunct in Fascia Iliaca Block During Positioning for Sub-arachnoid Block & Post-operative Analgesia After Femur Neck Fracture Surgery: A Randomized Control Trial
    Official Title
    Dexamethasone or Dexmedetomidine as Adjunct in Fascia Iliaca Block During Positioning for Sub-arachnoid Block & Post-operative Analgesia After Femur Neck Fracture Surgery: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aga Khan University Hospital, Pakistan

    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
    Femur fracture is a common injury occurring in the young due to trauma as well as amongst the elderly due to fall. Reduction and fixation of femur fractures pose a challenge to the anesthesiologist. These fractures are intensely painful as the pain arises from the periosteum and even slight movement can cause muscle forces to angulate and deform the fractured fragments which apart from causing extreme pain also make the reduction of the fracture quite difficult. Sub-arachnoid block (SAB) is a commonly used technique for lower-limb surgeries. It provides excellent surgical anesthesia and is a largely safe and reliable anesthetic technique. However, for femur fracture repair, positioning the patient for SAB not only causes extreme pain but it also makes administration of SAB difficult due to inappropriate position. Another limitation of SAB is its limited duration of action. Hence, conventional pain management modalities which include opioids and NSAIDs are used to manage pain before and during the administration of SAB and during the post-operative period. These conventional pain management drugs are associated with significant adverse effects and should be used with caution especially in the elderly with multiple comorbids. Recently, fascia iliaca block (FICB) has been used not only as part of multi-modal peri-operative analgesic regime for femur fractures but also to provide adequate analgesia for appropriate SAB positioning. FICB fills the plane underneath the fascia iliaca with local anesthetic and acts on the femoral, lateral femoral cutaneous and obturator nerves and thus provides adequate analgesia for femur fractures for up to 24-48 hours. FICB is also associated with less side effects when compared to conventional pain management modalities and provides adequate unilateral analgesia with fewer autonomic and neurological complications when compared with epidural analgesia. Traditionally, local anesthetics have been used for most of the peripheral nerve blocks (PNB), however multiple adjuncts such as opioids, ketamine and clonidine have been used to prolong the duration of action as well as decrease the local anesthetic dosage. Among the adjuncts, dexamethasone has been used to generally favorable results in PNBs. Dexmedetomidine is another promising drug being used as a local anaesthetic adjuvant in peripheral nerve blocks. It is an alpha-2 agonist, which has shown to have prolonged duration of postoperative analgesia when given with LA for peripheral nerve blocks with other beneficial effects such as reducing the opioid consumption. In this study, the investigators compare dexamethasone with dexmedetomidine as an adjunct when combined with ropivacaine in FICB.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Patients allocated to group A will receive ultrasound guided FICB with 0.375% ropivacaine 38 cc along with 8 mg dexamethasone in 2cc making a total injection volume of 40 cc.
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    Patients allocated to group B will receive ultrasound guided FICB with 0.375% ropivacaine 38 cc along with 1 µg/kg dexmedetomidine in 2cc dilution making a total injection volume of 40 cc.
    Arm Title
    Group C
    Arm Type
    No Intervention
    Arm Description
    Patients allocated to group C will receive ultrasound guided FICB with 0.375% ropivacaine 38 cc along with 2 cc normal saline making a total injection volume of 40 cc. This will serve as the control arm.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    Dexamethasone has been used to generally favorable results in peripheral nerve blocks as adjunct. Several studies have reported prolongation in the duration of ropivacaine, mepivacaine and bupivacaine when used in combination with dexamethasone. Various mechanisms for the beneficial adjunctive effect of dexamethasone with Local Anesthetics (LA) have been proposed. One theory suggests that the improved analgesia and increased blockade duration is due to its anti-inflammatory properties. It also acts as a local vasoconstrictor and thus may act by reducing LA absorption. Furthermore, it also increases the activity of inhibitory potassium channels on nociceptive C-Fibers.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Intervention Description
    Dexmedetomidine is another promising drug being used as a local anaesthetic adjuvant in peripheral nerve blocks. It is an alpha-2 agonist, which has shown to have prolonged duration of postoperative analgesia when given with LA for peripheral nerve blocks with other beneficial effects such as reducing the opioid consumption. Alpha-2-agonists such as dexmedetomidine cause hyperpolarization-activated cation currents which inhibit the transmission of nociceptive fibers.
    Primary Outcome Measure Information:
    Title
    Pain score after fascia iliaca block placement
    Description
    Static pain will be recorded at 5 minute interval with the help of Numeric Rating Scale (NRS) of 0 to 10 (with 0 being no pain at all and 10 being worst imaginable pain).
    Time Frame
    Static Pain at 5 minutes after placement of block.
    Title
    Pain score after fascia iliaca block placement
    Description
    Static pain will be recorded at 10-minute interval with the help of Numeric Rating Scale (NRS) of 0 to 10 (with 0 being no pain at all and 10 being worst imaginable pain).
    Time Frame
    Static Pain (at 10 minutes after placement of block.
    Title
    Pain score during positioning of patient for sub-arachnoid block
    Description
    After 15 minutes of fascia iliaca block placement, patients will be positioned for sub-arachnoid block. At this point, dynamic pain will be recorded with the help of Numeric Rating Scale (NRS) of 0 to 10 (with 0 being no pain at all and 10 being worst imaginable pain).
    Time Frame
    Dynamic Pain during positioning for sub-arachnoid block
    Secondary Outcome Measure Information:
    Title
    Duration of postoperative analgesia
    Description
    This will be measured by the demand to first rescue analgesic
    Time Frame
    Till 24 hours post surgery
    Title
    Post-operative Pain
    Description
    Post-operative pain will be assessed via the Numeric Rating Scale (NRS) of 0 to 10 (with 0 being no pain at all and 10 being worst imaginable pain).
    Time Frame
    Arrival in PACU (0 hours)
    Title
    Post-operative Pain
    Description
    Post-operative pain will be assessed Numeric Rating Scale (NRS) of 0 to 10 (with 0 being no pain at all and 10 being worst imaginable pain).
    Time Frame
    6 hours after surgery
    Title
    Post-operative Pain
    Description
    Post-operative pain will be assessed via the Numeric Rating Scale (NRS) of 0 to 10 (with 0 being no pain at all and 10 being worst imaginable pain).
    Time Frame
    12 hours after surgery
    Title
    Post-operative Pain
    Description
    Post-operative pain will be assessed via the Numeric Rating Scale (NRS) of 0 to 10 (with 0 being no pain at all and 10 being worst imaginable pain).
    Time Frame
    24 hours after surgery
    Title
    Patient Satisfaction
    Description
    Patient satisfaction would be assessed via the Likert Scale
    Time Frame
    24 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age group (18-80) Undergoing elective/emergency femur fracture repair under sub-arachnoid block ASA status I-III Exclusion Criteria: Participation in any other trial Known hypersensitivity to study medications Seizure disorder Coagulation disorder Infection over injection site Hemodynamic Instability Concurrent medications use that is contraindicated with study medications
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Haris Sheikh, MBBS
    Phone
    03452432387
    Email
    hsheikh957@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Samie Asghar, MBBS, FCPS
    Email
    samie.asghar@aku.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Samie Asghar, MBBS, FCPS
    Organizational Affiliation
    Aga Khan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Dexamethasone or Dexmedetomidine as Adjunct in Fascia Iliaca Block During Positioning for Sub-arachnoid Block & Post-operative Analgesia After Femur Neck Fracture Surgery: A Randomized Control Trial

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