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

Regional Anesthesia Clinical Trial

Official title:

The Effect of Adjuvant Dexamethasone on Postoperative Pain, Analgesic Consumption and Block Properties in Suprainguinal Fascia Iliaca Block (SFIB) in Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05979597
• Other study ID #: SFIB-TEZ
• Status: Completed
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: April 2024
• Source: Samsun Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 15, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Regional Anesthesia

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Samsun Research and Education Hospital	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Samsun Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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 — View 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 prelimina — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption	First 24 hours total morphine consumption with patient controlled analgesia	Postoperative 24 hours
Secondary	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.	Postoperative 24 hours
Secondary	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	at 24th hour
Secondary	Quadriceps muscle strength	will be evaluated in a scale between 1-5 (1:lowest; 5:normal)	at 24th hour