Analgesic Efficacy of Fascia Iliaca Compartment Block

NCT03957499 | Unknown Phase 1

• 1 other identifier: Beni-Suef Faculty of Medicine
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

the control group

PLACEBO COMPARATOR

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

Group dexamethasone/Bupivacaine:

ACTIVE COMPARATOR

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

Group Magnesium sulphate/Bupivacaine

ACTIVE COMPARATOR

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

Interventions

Bupivacaine 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).(

Also known as: Marcain

the control group

Dexamethasone/bupivacaine 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 dexamethasone/Bupivacaine:

Magnesium Sulfate/bupivacaine 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).

Group Magnesium sulphate/Bupivacaine

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samaa Rashwan: lead

Study Sites (1)

Beni-Suef University Hospital

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine; Dexamethasone; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Samaa Rashwan, MD

  Assisstant proffesor of anesthesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samaa Rashwan, MD

CONTACT

020120159125; samakassemrashwan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The anesthetists who will prepare the drug and who will collect the data will be blinded to the study protocol
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 21, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)