Evaluation of Postoperative Analgesic Efficacy of Suprainguinal Fascia Iliaca Block

NCT05450211 | Completed

• 1 other identifier: OYKU55
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

It was aimed to evaluate the postoperative analgesic efficacy of the suprainguinal fascia iliaca block applied in the postoperative period in terms of 24-hour opioid consumption, pain score, additional analgesic need, and side effects and complications in the postoperative period, and to see the postoperative analgesic effectiveness of this block in patients who underwent knee arthroplasty.

Conditions

Regional Anesthesia

Keywords

regional analgesia; suprainguinal fascia iliaca block; patient controlled analgesia

Outcome Measures

Primary Outcomes (1)

• Analgesic consumption

  To determine the amount of analgesic consumption in the postoperative first 24 hours with PCA in the postoperative period.

  Postoperative 24 hours

Secondary Outcomes (1)

• Numerical Rating Scale

  Postoperative 24 hours

Study Arms (2)

Group SFI (Suprainguinal fascia iliaca block)

ACTIVE COMPARATOR

In the patient lying in the supine position, a high-frequency linear probe is inserted under sterile conditions, using an in-plane technique, 1 cm cephalad of the inguinal ligament with an 85 mm needle. Using hydro-dissection, the fascia iliaca is separated from the iliac muscle and a space is created where the needle can be advanced cranially, and the procedure will be completed by injecting local anesthetic into this space. When the patient whose block procedure is successful, is taken to the recovery room, controlled analgesia will be applied to the patient and he will be transferred to the ward. Tramadol HCL will be used for postoperative pain control for PCA.

Device: Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy); Device: Patient controlled analgesia

Group PCA (patient controlled analgesia)

ACTIVE COMPARATOR

No block attempt will be made to the patients in this group, and when the patient is taken to the recovery room after surgery, controlled analgesia will be administered and transferred to the ward. Tramadol HCL will be used for postoperative pain control for PCA.

Device: Patient controlled analgesia

Interventions

Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy) DEVICE

A low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy) device will be used while blocking in group SFI.

Group SFI (Suprainguinal fascia iliaca block)

Patient controlled analgesia DEVICE

Patient-controlled analgesia will be used for pain control after surgery in both groups.

Group PCA (patient controlled analgesia); Group SFI (Suprainguinal fascia iliaca block)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having undergone unilateral knee replacement surgery under elective conditions,
• Age range of 18-75 years,
• ASA score I and II,
• Body mass index \< 35kg/m²,
• written consent who agreed to participate in the study.

You may not qualify if:

• who do not want to be included in the study by not signing the voluntary consent form,
• Body mass index \> 35 kg/m²,
• Local infection, hematoma, hernia, neoplasm etc. in the area to be blocked. found,
• Coagulopathy, hepatic or renal failure,
• Allergic to a local anesthetic agent or one of the drugs used in the study,
• Having a history of chronic opioid and corticosteroid use,
• who cannot use the patient-controlled analgesia system and have a psychiatric disease,
• with operative time less than 20 minutes and more than 120 minutes for better standardization of studies.

Sponsors & Collaborators

• Samsun Education and Research Hospital: lead

Study Sites (1)

Samsun Research and Education Hospital

Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (4)

• Seo SS, Kim OG, Seo JH, Kim DH, Kim YG, Park BY. Comparison of the Effect of Continuous Femoral Nerve Block and Adductor Canal Block after Primary Total Knee Arthroplasty. Clin Orthop Surg. 2017 Sep;9(3):303-309. doi: 10.4055/cios.2017.9.3.303. Epub 2017 Aug 4.

  PMID: 28861197 RESULT

• Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.

  PMID: 28059869 RESULT

• 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.

  PMID: 21401544 RESULT

• 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.

  PMID: 30250982 RESULT

MeSH Terms

Interventions

Analgesia, Patient-Controlled

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Mustafa Suren, Professor

  Samsun Research and Education Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The patient will not know which study group he is in. The anesthetist, who will perform the regional block, will give the block to be applied in a sealed envelope by an assistant staff outside the study, and at the same time, the patient will not know which block has been made. The anesthesiologist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another investigator blinded to the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Principal Investigator

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 8, 2022
• Study Start: July 25, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 9, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)