Analgesic Efficacy of Fascia Iliaca Compartment Block

Analgesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03957499
• Other study ID #: Beni-Suef Faculty of Medicine
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2019
• Est. completion date: December 2019

Study information

• Verified date: May 2019
• Source: Beni-Suef University
• Contact: Samaa Rashwan, MD
• Phone: 020120159125
• Email: samakassemrashwan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml of normal saline (total volume 30 ml).(
• Dexamethasone/bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed with 28 ml bupivacaine 0.25% + 2 ml dexamethasone (8mg) (total volume 30 ml)d using
• Magnesium Sulfate/bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml magnesium sulphate (200mg) (total volume 30 ml).

Locations

Country	Name	City	State
Egypt	Beni-Suef University Hospital	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Samaa Rashwan

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesia	the duration of effective analgesia will be considered as the duration after performing the FICB till the patient ask for first analgesic dose ,in this case pethidin 25 mg will be given intravenously	duration from the end of surgery till the first time to ask for post operative analgesia within the first 12 hours after surgery