Perineural Dexamethasone for Continuous Femoral Nerve Block

Total Knee Arthroplasty Clinical Trial

Official title:

Analgesic Effect of Dexamethasone as a Perineural Adjuvant for Continuous Femoral Nerve Block After Total Knee Arthroplasty: a Prospective Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05487001
• Other study ID #: 3-2022-0230
• Status: Completed
• Phase: N/A
• Start date: August 9, 2022
• Est. completion date: January 19, 2024

Study information

• Verified date: February 2024
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 19, 2024
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Procedure:
• dexamethasone group
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
• sham group
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

Locations

Country	Name	City	State
Korea, Republic of	GangnamSeverance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Numeric rating scale pain score at rest	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.	up to postoperative day 2
Secondary	Numeric rating scale pain score at movement	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.	up to postoperative day 2
Secondary	Postoperative opioid consumption	morphine equivalent dose	up to postoperative day 2