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
About this trial
This is an interventional treatment trial for Post Operative Pain
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
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
NCT ID
NCT05484648
First Posted
July 24, 2022
Last Updated
July 31, 2022
Sponsor
Aga Khan University Hospital, Pakistan
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
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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
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