Analgesic Efficacy of Fascia Iliaca Compartment Block

NCT ID: NCT03957499

Last Updated: 2019-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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 .

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
The anesthetists who will prepare the drug and who will collect the data will be blinded to the study protocol

Study Groups

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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).(

Group Type PLACEBO_COMPARATOR

Bupivacaine

Intervention Type DRUG

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).(

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).(

Group Type ACTIVE_COMPARATOR

Dexamethasone/bupivacaine

Intervention Type DRUG

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

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).

Group Type ACTIVE_COMPARATOR

Magnesium Sulfate/bupivacaine

Intervention Type DRUG

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).

Interventions

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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).(

Intervention Type 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

Intervention Type 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).

Intervention Type DRUG

Other Intervention Names

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Marcain

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samaa Rashwan

OTHER

Sponsor Role lead

Responsible Party

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Samaa Rashwan

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Samaa Rashwan, MD

Role: PRINCIPAL_INVESTIGATOR

Assisstant proffesor of anesthesia

Locations

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Beni-Suef University Hospital

Banī Suwayf, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Samaa Rashwan, MD

Role: CONTACT

020120159125

Facility Contacts

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Samaa Rashwan, MD

Role: primary

0201270159125

Other Identifiers

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Beni-Suef Faculty of Medicine

Identifier Type: -

Identifier Source: org_study_id

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