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

Primary Purpose

Regional Anesthesia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Suprainguinal fascia iliaca block
Suprainguinal fascia iliaca block+dexamethasone
Sponsored by
Samsun Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Regional Anesthesia focused on measuring regional anesthesia, suprainguinal fascia iliaca block, dexamethasone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Samsun Research and Education Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group SFIB (Suprainguinal fascia iliaca block)

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postoperative opioid consumption
First 24 hours total morphine consumption with patient controlled analgesia

Secondary Outcome Measures

Numerical Rating Scale
To determine the pain of the patients at rest and passive-active moving at the 1st, 3rd, 6th, 12th, 18th and 24th hours postoperatively with Numerical Rating Scale (NRS).The NRS is a segmented numerical version in which the respondent selects an integer (0-10) that best reflects the intensity of their pain. 0: no pain 1-3: mild pain 4-6: moderate pain 7-10: severe pain.
Timed up and go test (TUG)
TUG- evaluation of the time in seconds for the patient to get up from the chair and walk 3 meters and return to the chair again
Quadriceps muscle strength
will be evaluated in a scale between 1-5 (1:lowest; 5:normal)

Full Information

First Posted
July 29, 2023
Last Updated
August 6, 2023
Sponsor
Samsun Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05979597
Brief Title
The Effect of Adjuvant Dexamethasone on Postoperative Pain, Analgesic Consumption and Block Properties in SFIB
Official Title
The Effect of Adjuvant Dexamethasone on Postoperative Pain, Analgesic Consumption and Block Properties in Suprainguinal Fascia Iliaca Block (SFIB) in Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 10, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsun Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Total knee arthroplasty is one of the major orthopedic surgeries that cause severe postoperative pain. A successful post-operative outcome is possible with strong and effective pain control followed by early mobilization and a good functional recovery. Suprainguinal fascia iliaca plan block (SFIB) has been shown to be an effective postoperative method in multimodal analgesia regime in lower extremity surgery. It has been reported in the literature that dexamethasone added to local anaesthetics in peripheral nerve blocks prolongs the duration of sensory block, improves the quality of analgesia, reduces postoperative pain intensity and opioid consumption. In this study, the investigators aimed to demonstrate that dexamethasone added as an adjuvant to local anaesthetic agent in SFIB for effective postoperative analgesia after knee arthroplasty would prolong the duration of sensory block and reduce postoperative pain intensity and analgesic consumption. An identification number will be randomly assigned to each participants, whose written consent was obtained before the surgery, when they are admitted to the postoperative recovery room. In the postoperative period, participants will be followed up with these numbers. Which group the participants will be included in will be determined by the closed envelope method. Participants undergoing unilateral knee arthroplasty will be included in the study. Following the end of surgery, the participants will be divided into two groups in the recovery room and SFIB will be applied to both groups. Participants in group SFIB will receive 0.25% bupivacaine as local anaesthetic. Participants in group SFIB+dexamethasone will receive 0.25% bupivacaine as local anaesthetic and 8 mg dexamethasone as adjuvant. The participant with the block will be followed in the recovery room and if the block is successful, morphine patient controlled analgesia (PCA) treatment will be started and the participant will be taken to the ward. A standard analgesia regimen (1 g iv paracetamol every 8 hours, 50 mg iv dexketoprofen every 12 hours) was used in all participants. Evaluation of postoperative pain will be done with numerical rating scale (NRS). Pain levels will be questioned in two different ways as rest and passive moving.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Anesthesia
Keywords
regional anesthesia, suprainguinal fascia iliaca block, dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group SFIB (Suprainguinal fascia iliaca block)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group SFIB+dexa (Suprainguinal fascia iliaca block+dexamethasone)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Suprainguinal fascia iliaca block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Suprainguinal fascia iliaca block+dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
First 24 hours total morphine consumption with patient controlled analgesia
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
Numerical Rating Scale
Description
To determine the pain of the patients at rest and passive-active moving at the 1st, 3rd, 6th, 12th, 18th and 24th hours postoperatively with Numerical Rating Scale (NRS).The NRS is a segmented numerical version in which the respondent selects an integer (0-10) that best reflects the intensity of their pain. 0: no pain 1-3: mild pain 4-6: moderate pain 7-10: severe pain.
Time Frame
Postoperative 24 hours
Title
Timed up and go test (TUG)
Description
TUG- evaluation of the time in seconds for the patient to get up from the chair and walk 3 meters and return to the chair again
Time Frame
at 24th hour
Title
Quadriceps muscle strength
Description
will be evaluated in a scale between 1-5 (1:lowest; 5:normal)
Time Frame
at 24th hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hale Kefeli Celik, MD
Phone
+905057242409
Email
ck_hale@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elif Colak, Professor
Phone
+905323754163
Email
elifmangancolak@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Süren, Professor
Organizational Affiliation
Samsun Research and Education Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Samsun Research and Education Hospital
City
Samsun
ZIP/Postal Code
55090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Researched data and statistical analyzes will be available from the journal in which the clinical study was published
Citations:
PubMed Identifier
28861197
Citation
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.
Results Reference
result
PubMed Identifier
31272654
Citation
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.
Results Reference
result
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
result
PubMed Identifier
29121400
Citation
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.
Results Reference
result

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

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