Perineural Dexamethasone for Continuous Femoral Nerve Block

• Sponsor: Gangnam Severance Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05487001
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.4
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthroplasty	Procedure: dexamethasone group; Procedure: sham group	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• 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
• Anticipated Study Start Date: Aug 15, 2022
• Anticipated Primary Completion Date: Jul 26, 2024
• Anticipated Study Completion Date: Jul 26, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dexamethasone group a iliopsoas plane block before surgery	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 Comparator: sham group sham block before surgery	Procedure: 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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. Postoperative opioid consumption [up to postoperative day 2]

   morphine equivalent dose

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GangnamSeverance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Myoung Hwa Kim, Associate professor, Gangnam Severance Hospital
• ClinicalTrials.gov Identifier: NCT05487001
• Other Study ID Numbers: 3-2022-0230
• First Posted: Aug 4, 2022
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dexamethasone

Study Results

No Results Posted as of Aug 5, 2022