Perineural Dexamethasone for Continuous Femoral Nerve Block

NCT05487001 | Completed

• 1 other identifier: 3-2022-0230
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Maximum Numeric rating scale pain score at movement

  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.

  within postoperative day 2

Secondary Outcomes (3)

• Numeric rating scale pain score at rest

  up to postoperative day 2

• Numeric rating scale pain score at movement

  up to postoperative day 2

• Postoperative opioid consumption

  up to postoperative day 2

Study Arms (2)

dexamethasone group

EXPERIMENTAL

a iliopsoas plane block before surgery

Procedure: dexamethasone group

sham group

SHAM COMPARATOR

sham block before surgery

Procedure: sham group

Interventions

dexamethasone group PROCEDURE

1\) Arm l (dexamethasone group) Ultrasound-guided femoral nerve block with 1% lidocaine 15 ml after the end of surgery Postoperative femoral nerve patient controlled analgesia * Total volume 250 ml (0.375% ropivacaine 60 ml + normal saline 188 ml + dexamethasone 10 mg (2 ml)) * Basal rate 4 mL/hr, Bolus volume 2 mL, Lock-out time 15 min

dexamethasone group

sham group PROCEDURE

2\) Arm ll (sham group) Ultrasound-guided femoral nerve block with 1% lidocaine 15 ml after the end of surgery Postoperative femoral nerve patient controlled analgesia * Total volume 250 ml (0.375% ropivacaine 60 ml + normal saline 190 ml * Basal rate 4 mL/hr, Bolus volume 2 mL, Lock-out time 15 min

sham group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: August 9, 2022
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)