Back to results

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

Primary Purpose

Postoperative Pain

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

continuous epidural analgesia

supra-inguinal fascia iliaca compartment block

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Alexandria faculty of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

continuous epidural analgesia

continuous supra-inguinal fascia iliaca compartment block

Arm Description

continuous lumbar epidural catheter inserted preoperatively before induction of general anaesthesia

ultrasound guided supra-inguinal FICB with insertion of catheter for continuous infusion before induction of general anaesthesia.

Outcomes

Primary Outcome Measures

postoperative analgesia after THA surgery

visual analogue scale (VAS) scores for pain assessment at rest and movements and morphine consumption

Secondary Outcome Measures

radiological pattern of local anaesthetic distribution in S-FICB group

imaging of pelvis using x-rays c arm machine

success of rehabilitation

rehabilitation indices achievement after THA

Full Information

NCT ID

NCT04196439

First Posted

November 1, 2019

Last Updated

December 10, 2019

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04196439

Brief Title

Continuous Epidural Analgesia Versus Continuous Supra-Inguinal Fascia Iliaca Block in Total Hip Replacement Surgery

Acronym

S-FICB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 2, 2019 (Actual)

Primary Completion Date

February 2020 (Anticipated)

Study Completion Date

March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

continuous epidural analgesia

Arm Type

Active Comparator

Arm Description

continuous lumbar epidural catheter inserted preoperatively before induction of general anaesthesia

Arm Title

continuous supra-inguinal fascia iliaca compartment block

Arm Type

Active Comparator

Arm Description

ultrasound guided supra-inguinal FICB with insertion of catheter for continuous infusion before induction of general anaesthesia.

Intervention Type

Procedure

Intervention Name(s)

continuous epidural analgesia

Other Intervention Name(s)

continuous epidural anaesthesia

Intervention Description

injection of local anaesthetic into epidural space

Intervention Type

Procedure

Intervention Name(s)

supra-inguinal fascia iliaca compartment block

Other Intervention Name(s)

Supra-inguinal FICB

Intervention Description

ultrasound guided injection of local anaesthetic into fascia iliaca compartment

Primary Outcome Measure Information:

Title

postoperative analgesia after THA surgery

Description

visual analogue scale (VAS) scores for pain assessment at rest and movements and morphine consumption

Time Frame

36 hours

Secondary Outcome Measure Information:

Title

radiological pattern of local anaesthetic distribution in S-FICB group

Description

imaging of pelvis using x-rays c arm machine

Time Frame

30 minutes after local anaesthetic injection

Title

success of rehabilitation

Description

rehabilitation indices achievement after THA

Time Frame

36 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ahmad S alabd, master

Phone

0020 1001643215

ahmadsam23@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emad A Abdelmonem, M.D.

Organizational Affiliation

Alexandria faculty of medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Alexandria faculty of medicine

City

Alexandria

ZIP/Postal Code

21131

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emad A abdelmoem, M.D.

Phone

034844887

IMAD.AREDA@alexmed.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30798268

Citation

Vermeylen K, Desmet M, Leunen I, Soetens F, Neyrinck A, Carens D, Caerts B, Seynaeve P, Hadzic A, Van de Velde M. Supra-inguinal injection for fascia iliaca compartment block results in more consistent spread towards the lumbar plexus than an infra-inguinal injection: a volunteer study. Reg Anesth Pain Med. 2019 Feb 22:rapm-2018-100092. doi: 10.1136/rapm-2018-100092. Online ahead of print.

Results Reference

background

PubMed Identifier

21401544

Citation

Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.

Results Reference

background

PubMed Identifier

30250982

Citation

Vermeylen K, Soetens F, Leunen I, Hadzic A, Van Boxtael S, Pomes J, Prats-Galino A, Van de Velde M, Neyrinck A, Sala-Blanch X. The effect of the volume of supra-inguinal injected solution on the spread of the injectate under the fascia iliaca: a preliminary study. J Anesth. 2018 Dec;32(6):908-913. doi: 10.1007/s00540-018-2558-9. Epub 2018 Sep 24.

Results Reference

background

PubMed Identifier

27943417

Citation

Bullock WM, Yalamuri SM, Gregory SH, Auyong DB, Grant SA. Ultrasound-Guided Suprainguinal Fascia Iliaca Technique Provides Benefit as an Analgesic Adjunct for Patients Undergoing Total Hip Arthroplasty. J Ultrasound Med. 2017 Feb;36(2):433-438. doi: 10.7863/ultra.16.03012. Epub 2016 Dec 10.

Results Reference

background

PubMed Identifier

27684871

Citation

Bang S, Chung J, Jeong J, Bak H, Kim D. Efficacy of ultrasound-guided fascia iliaca compartment block after hip hemiarthroplasty: A prospective, randomized trial. Medicine (Baltimore). 2016 Sep;95(39):e5018. doi: 10.1097/MD.0000000000005018.

Results Reference

background

Learn more about this trial

Continuous Epidural Analgesia Versus Continuous Supra-Inguinal Fascia Iliaca Block in Total Hip Replacement Surgery

We'll reach out to this number within 24 hrs