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

NCT ID: NCT05484648

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

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.

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

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.

Group B

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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.

Group C

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dexamethasone

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

Dexmedetomidine

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aga Khan University Hospital, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Haris Sheikh

Post-Graduate Trainee, Department of Anaesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samie Asghar, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Central Contacts

Haris Sheikh, MBBS

Role: CONTACT

hsheikh957@gmail.com

03452432387

Samie Asghar, MBBS, FCPS

Role: CONTACT

samie.asghar@aku.edu

Other Identifiers

7886

Identifier Type: -

Identifier Source: org_study_id