Continuous Epidural Analgesia Versus Continuous Supra-Inguinal Fascia Iliaca Block in Total Hip Replacement Surgery (S-FICB)

December 10, 2019 updated by: Ahmad Samir Alabd, Alexandria University

Comparison Of Continuous Epidural Analgesia And Ultrasound Guided Continuous Supra-Inguinal Fascia Iliaca Compartment Block After Total Hip Replacement Surgery

comparison of continuous epidural analgesia and ultrasound guided continuous supra-inguinal fascia iliaca compartment block after total hip replacement surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

supra-inguinal FICB is a promising safe approach for lumbar plexus that may be useful for analgesia in hip surgeries.In this study the investigators are comparing continuous S-FICB with continuous epidural analgesia after total hip arthroplasty surgeries with the primary aim to assess efficacy of post-operative analgesia, and secondary aim to assess rehabilitation indices, side effects and radiological pattern of local anaesthetic distribution after S-FICB.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt, 21131
        • Recruiting
        • Alexandria Faculty of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • orthopaedic patients, American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral total hip replacement surgery via lateral approach

Exclusion Criteria:

  • 1- History of neurological/neuromuscular, psychiatric disease, dementia preventing proper comprehension.

    2- Patients younger than 18 years or older than 80 years. 3- Patients with Body Mass Index (BMI) <18.5 or >30 kg/m2. 4- Coagulation disturbances (INR>1.4, platelet count<100 000). 5- History of opioid dependence (opioid use within the last 4 weeks). 6- History of allergies to study medications. 7- Other contraindications to neuraxial blockade (e.g., patient refusal, local/systemic sepsis, low fixed cardiac output).

    8- Contraindications to continuous fascia iliaca compartment block (e.g., infection overlying the injection site or previous femoro-popliteal bypass surgery).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: continuous epidural analgesia
continuous lumbar epidural catheter inserted preoperatively before induction of general anaesthesia
Procedure: continuous epidural analgesia
injection of local anaesthetic into epidural space
Other Names:
  • continuous epidural anaesthesia
Active Comparator: continuous supra-inguinal fascia iliaca compartment block
ultrasound guided supra-inguinal FICB with insertion of catheter for continuous infusion before induction of general anaesthesia.
Procedure: supra-inguinal fascia iliaca compartment block
ultrasound guided injection of local anaesthetic into fascia iliaca compartment
Other Names:
  • Supra-inguinal FICB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative analgesia after THA surgery
Time Frame: 36 hours
visual analogue scale (VAS) scores for pain assessment at rest and movements and morphine consumption
36 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiological pattern of local anaesthetic distribution in S-FICB group
Time Frame: 30 minutes after local anaesthetic injection
imaging of pelvis using x-rays c arm machine
30 minutes after local anaesthetic injection
success of rehabilitation
Time Frame: 36 hours
rehabilitation indices achievement after THA
36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Chair: Emad A Abdelmonem, M.D., Alexandria Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2019

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

November 1, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • supra-inguinal fascia iliaca

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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