Clinical trial NCT03957499: Analgesic Efficacy of Fascia Iliaca Compartment Block
Official title: Analgesic Efficacy of Fascia Iliaca Compartment Block With Bupivacaine Versus Bupivacaine With Dexamethasone or Magnesium Sulphate for Dynamic Hip Screw Surgeries Randomized Double Blinded Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Analgesia
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the analgesic efficacy of fascia iliaca compartment block using bupivacaine versus bupivacaine with dexamethasone or magnesium sulphate for dynamic hip screw surgery under spinal anesthesia.

The primary outcome will be the duration of effective analgesia from FICB till the first analgesic dose is required,the secondary outcomes will be the severity of postoperative pain as will be assessed by the visual analogue scale and the total dose of pethidin for rescue analgesia.

Detailed description: Different modes of analgesia are given prior to neuraxial blockade for pain relief like non-steroidal anti-inflammatory drugs (NSAID), opioids and peripheral nerve blocks such as, femoral nerve block, 3 in 1 block or fascia iliaca compartment block (FICB).

FICB is believed to be most beneficial compared to other procedures because of its safety and efficacy . FICB provides blockage of at least two of the three major nerves that supply the medial, anterior and lateral thigh with one simple injection, namely the femoral and lateral femoral cutaneous nerves.

FICB is an anterior approach to the lumbar plexus. The pop technique using fascial click had a low success rate of 35% - 47% .However, as the FICB was performed under real-time ultrasound guidance, the success rate was increased up to 82- 87%, leading to an increased interest in FICB as a postoperative analgesia option for hip and knee surgical procedures .

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology physical status (ASA) I \& II of both sex.
* Age between 20 and 70 years.
* Patients with traumatic hip fracture presenting for elective or emergency dynamic hip screw (DHS) fixation under spinal anesthesia.

Exclusion Criteria:

* Patient refused to give consent
* Patients with history of allergy to dexamethasone, magnesium sulphate or bupivacaine.
* Patients with contraindications to spinal anesthesia.
* Previous surgery in the affected hip, infection at the injection site, multiple fractures.
* Peripheral neuropathy.
* Use of analgesics within 8 hours before the spinal block.
* Inguinal hernia, and femoral artery graft.

Primary outcomes:
measure: Analgesia
timeFrame: duration from the end of surgery till the first time to ask for post operative analgesia within the first 12 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef University Hospital
Study officials:
affiliation: Assisstant proffesor of anesthesia
name: Samaa Rashwan, MD
role: PRINCIPAL_INVESTIGATOR
References: