Total Knee ArthroplastyNCT05487001
Perineural Dexamethasone for Continuous Femoral Nerve Block
A study testing dexamethasone group in people with Total Knee Arthroplasty, run by Gangnam Severance Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- dexamethasone group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Aug 2022to 19 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
- ASA PS 1-3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- dexamethasone group, sham group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone groupProcedure or surgery
- 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 groupProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone group | Experimental | a iliopsoas plane block before surgery Receives: Procedure: dexamethasone group |
| sham group | Sham comparator | sham block before surgery Receives: Procedure: sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within postoperative day 2
Secondary outcomes (3)
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.
Measured: up to postoperative day 2
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.
Measured: up to postoperative day 2
Postoperative opioid consumption
morphine equivalent dose
Measured: up to postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start9 Aug 2022
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myoung Hwa Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487001
- Sponsor's protocol ID
- 3-2022-0230
- Status last verified
- Feb 2024
- First submitted
- 2 Aug 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05487001
- Acronym / sponsor ID
- 3-2022-0230
- Conditions
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone group | Experimental | Procedure: dexamethasone groupa iliopsoas plane block before surgery |
| sham group | Sham comparator | Procedure: sham groupsham block before surgery |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
- ASA PS 1-3
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone group1) 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 | Procedure or surgery | dexamethasone group |
| sham group2) 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 | Procedure or surgery | sham group |
Primary outcome
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.
3 secondary outcomes
Numeric rating scale pain score at rest
Time frame: up to postoperative day 2
Numeric rating scale pain score at movement
Time frame: up to postoperative day 2
Postoperative opioid consumption
Time frame: up to postoperative day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexamethasone group in people with Total Knee Arthroplasty, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Numeric rating scale pain score at movement (time frame: within postoperative day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.