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Completed

NCT Number: NCT05487001

Perineural Dexamethasone for Continuous Femoral Nerve Block

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GangnamSeverance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

dexamethasone group

Procedure
  • 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

Procedure
  • 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

Primary outcomes

  1. Maximum Numeric rating scale pain score at movement

    Time frame: 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 outcomes

  1. Numeric rating scale pain score at rest

    Time frame: 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

    Time frame: 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

    Time frame: up to postoperative day 2

    morphine equivalent dose

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 4, 2022
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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