The Effect of Adjuvant Dexamethasone on Postoperative Pain, Analgesic Consumption and Block Properties in SFIB

NCT05979597 | Completed

• 1 other identifier: SFIB-TEZ
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aimed to demonstrate that dexamethasone added as an adjuvant to local anaesthetic agent in suprainguinal fascia iliaca block for effective postoperative analgesia after knee arthroplasty would prolong the duration of sensory block and reduce postoperative pain intensity and analgesic consumption.

Conditions

Regional Anesthesia

Keywords

regional anesthesia; suprainguinal fascia iliaca block; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid consumption

  First 24 hours total morphine consumption with patient controlled analgesia

  Postoperative 24 hours

Secondary Outcomes (3)

• Numerical Rating Scale

  Postoperative 24 hours

• Timed up and go test (TUG)

  at 24th hour

• Quadriceps muscle strength

  at 24th hour

Study Arms (2)

Group SFIB (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 a 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.

Procedure: Suprainguinal fascia iliaca block

Group SFIB+dexa (Suprainguinal fascia iliaca block+dexamethasone)

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 a 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+dexamethasone into this space.

Procedure: Suprainguinal fascia iliaca block+dexamethasone

Interventions

Suprainguinal fascia iliaca block PROCEDURE

After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic injection will be made between the fascia and the muscle.

Group SFIB (Suprainguinal fascia iliaca block)

Suprainguinal fascia iliaca block+dexamethasone PROCEDURE

After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic+dexamethasone injection will be made between the fascia and the muscle.

Group SFIB+dexa (Suprainguinal fascia iliaca block+dexamethasone)

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,
• American Society of Anesthesiologist's physiologic state I-III patients,
• written consent who agreed to participate in the study.

You may not qualify if:

• BMI\>35
• who do not want to be included in the study by not signing the voluntary consent form,
• 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, Balocco AL, Van Belleghem V. Fascia iliaca compartment blocks: Different techniques and review of the literature. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):57-66. doi: 10.1016/j.bpa.2019.03.004. Epub 2019 Apr 17.

  PMID: 31272654 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

• Pehora C, Pearson AM, Kaushal A, Crawford MW, Johnston B. Dexamethasone as an adjuvant to peripheral nerve block. Cochrane Database Syst Rev. 2017 Nov 9;11(11):CD011770. doi: 10.1002/14651858.CD011770.pub2.

  PMID: 29121400 RESULT

Study Officials

• Mustafa Süren, 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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Principal Investigator

Study Record Dates

• First Submitted: July 29, 2023
• First Posted: August 7, 2023
• Study Start: August 10, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 15, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)