Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04196439
Other study ID # supra-inguinal fascia iliaca
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2, 2019
Est. completion date March 2020

Study information

Verified date December 2019
Source Alexandria University
Contact ahmad S alabd, master
Phone 0020 1001643215
Email ahmadsam23@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 2020
Est. primary completion date February 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
continuous epidural analgesia
injection of local anaesthetic into epidural space
supra-inguinal fascia iliaca compartment block
ultrasound guided injection of local anaesthetic into fascia iliaca compartment

Locations

Country Name City State
Egypt Alexandria faculty of medicine Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View 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. — View 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. — View 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. pii: rapm-2018-100092. doi: 10.1136/rapm-2018-100092. [Epub ahead of print] — View Citation

Vermeylen K, Soetens F, Leunen I, Hadzic A, Van Boxtael S, Pomés 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative analgesia after THA surgery visual analogue scale (VAS) scores for pain assessment at rest and movements and morphine consumption 36 hours
Secondary radiological pattern of local anaesthetic distribution in S-FICB group imaging of pelvis using x-rays c arm machine 30 minutes after local anaesthetic injection
Secondary success of rehabilitation rehabilitation indices achievement after THA 36 hours
See also
  Status Clinical Trial Phase
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT03181620 - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Recruiting NCT06007378 - Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery N/A
Recruiting NCT05943015 - Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks N/A
Completed NCT04544228 - Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy N/A
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03663478 - Continuous TQL Block for Elective Cesarean Section Phase 4
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Completed NCT05170477 - Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment N/A
Not yet recruiting NCT04561856 - Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone Phase 4
Completed NCT06425601 - A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy N/A
Completed NCT03612947 - TAP Block in Laparoscopic Cholecystectomy. Phase 2
Completed NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05995912 - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain Phase 2
Completed NCT04571515 - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain Phase 2
Active, not recruiting NCT04190355 - The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain N/A
Recruiting NCT05145153 - Incidence of Chronic Pain After Thoracic Surgery
Recruiting NCT03697278 - Monitoring Postoperative Patient-controlled Analgesia (PCA) N/A