Clinical trial NCT05484648: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post Operative Pain
Lead sponsor: Aga Khan University Hospital, Pakistan
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain score after fascia iliaca block placement
timeFrame: Static Pain at 5 minutes after placement of block.
measure: Pain score after fascia iliaca block placement
timeFrame: Static Pain (at 10 minutes after placement of block.
measure: Pain score during positioning of patient for sub-arachnoid block
timeFrame: Dynamic Pain during positioning for sub-arachnoid block
Secondary outcomes:
measure: Duration of postoperative analgesia
timeFrame: Till 24 hours post surgery
measure: Post-operative Pain
timeFrame: Arrival in PACU (0 hours)
measure: Post-operative Pain
timeFrame: 6 hours after surgery
measure: Post-operative Pain
timeFrame: 12 hours after surgery
measure: Post-operative Pain
timeFrame: 24 hours after surgery
measure: Patient Satisfaction
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Aga Khan University
name: Samie Asghar, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
References: