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

NCT ID: NCT05979597

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2024-01-15

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.

Conditions

Regional Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group SFIB (Suprainguinal fascia iliaca block)

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.

Group Type: ACTIVE_COMPARATOR

Suprainguinal fascia iliaca block

Intervention Type: 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+dexa (Suprainguinal fascia iliaca block+dexamethasone)

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.

Group Type: ACTIVE_COMPARATOR

Suprainguinal fascia iliaca block+dexamethasone

Intervention Type: 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.

Interventions

Suprainguinal fascia iliaca block

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

Suprainguinal fascia iliaca block+dexamethasone

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsun Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hale Kefeli Celik

Anesthesiologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mustafa Süren, Professor

Role: STUDY_CHAIR

Samsun Research and Education Hospital

Locations

Samsun Research and Education Hospital

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 28861197 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31272654 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30250982 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29121400 (View on PubMed)

Other Identifiers

SFIB-TEZ

Identifier Type: -

Identifier Source: org_study_id