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Analgesic Efficacy of Fascia Iliaca Compartment Block

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ClinicalTrials.gov Identifier: NCT03957499
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Samaa Rashwan, Beni-Suef University

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.


Condition or disease Intervention/treatment Phase
Analgesia Drug: Bupivacaine Drug: Dexamethasone/bupivacaine Drug: Magnesium Sulfate/bupivacaine Phase 1

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 .


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: The anesthetists who will prepare the drug and who will collect the data will be blinded to the study protocol
Primary Purpose: Treatment
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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Placebo Comparator: the control group
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).(
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).(
Other Name: Marcain

Active Comparator: Group dexamethasone/Bupivacaine:
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using with 28 ml bupivacaine 0.25% + 2 ml dexamethasone (8mg) (total volume 30 ml).(
Drug: 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

Active Comparator: Group Magnesium sulphate/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).
Drug: 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).




Primary Outcome Measures :
  1. Analgesia [ Time Frame: duration from the end of surgery till the first time to ask for post operative analgesia within the first 12 hours after surgery ]
    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



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957499


Contacts
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Contact: Samaa Rashwan, MD 020120159125 samakassemrashwan@gmail.com

Locations
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Egypt
Beni-Suef University Hospital Recruiting
Banī Suwayf, Egypt
Contact: Samaa Rashwan, MD    0201270159125      
Sponsors and Collaborators
Samaa Rashwan
Investigators
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Principal Investigator: Samaa Rashwan, MD Assisstant proffesor of anesthesia

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Responsible Party: Samaa Rashwan, Principal Investigator, Beni-Suef University
ClinicalTrials.gov Identifier: NCT03957499     History of Changes
Other Study ID Numbers: Beni-Suef Faculty of Medicine
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Magnesium Sulfate
Bupivacaine
BB 1101
Analgesics
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Tocolytic Agents