Perineural Dexamethasone for Continuous Femoral Nerve Block

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Procedure: dexamethasone group; Procedure: sham group

• Registration Number: NCT05487001
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

An alternative to improve the quality of postoperative analgesia is to use various perineural adjuvants applicable to peripheral nerve block along with local anesthetics to increase the analgesic effect. Dexamethasone is a strong and long-acting corticosteroid, which reduces postoperative nausea and vomiting and increases the duration of nerve blockade. Most of the existing clinical studies compared the analgesic effect with the placebo group after adding an adjuvant in a single shot nerve block, and there were very few cases of comparing the analgesic effect with the placebo group after adding the adjuvant in peripheral nerve block through continuous catheter infusion. Therefore, we designed this study to investigate whether the use of dexamethasone as a peripheral adjuvant for continuous femoral nerve block has a better pain and recovery profile.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-04
• Study Start: 2022-08-09
• Primary Completion: 2024-01-19
• Study Completion: 2024-01-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
2. ASA PS 1-3

Exclusion Criteria

1. Revision total hip arthroplasty
2. Allergy to drugs used in the study
3. Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
4. Estimated glomerular filtration rate < 30 mL/min/1.73m2
5. Opioid dependence
6. Prolongation of PT and aPTT more than twice the upper limit of normal
7. Pre-existing neurological or anatomical disorders of the lower extremities
8. Serious psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexamethasone group	dexamethasone group	a iliopsoas plane block before surgery
sham group	sham group	sham block before surgery

Primary Outcome Measures

Name	Time	Method
Maximum Numeric rating scale pain score at movement	within postoperative day 2	Pain intensity at movement will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) postoperative 1 hour, postoperative 6 hours, postoperative day 1, postoperative day 2. Maximum Numeric rating scale pain score was determined based on highest score among repeated assessment of surgical site pain severity postoperatively.

Secondary Outcome Measures

Name	Time	Method
Numeric rating scale pain score at rest	up to postoperative day 2	Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) postoperative 1 hour, postoperative 6 hours, postoperative day 1, postoperative day 2.
Postoperative opioid consumption	up to postoperative day 2	morphine equivalent dose
Numeric rating scale pain score at movement	up to postoperative day 2	Pain intensity during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) postoperative 1 hour, postoperative 6 hours, postoperative day 1, postoperative day 2.

Trial Locations

Locations (1)

GangnamSeverance Hospital; 🇰🇷 Seoul, Korea, Republic of