Total Knee ArthroplastyNCT00616603
The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks
A study testing Ropivacaine, Dexamethasone and Normal Saline in people with Total Knee Arthroplasty, run by Loma Linda University at 1 site in United States.
Trial summary
Dexamethasone is a commonly used steroid. This medication has been used for many years by physicians for many different indications. Recent articles, multiple case reports, and experience at this institution have indicated that dexamethasone successfully prolongs the effective duration of local anesthetics for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Ropivacaine, Dexamethasone and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 yrs, male or female subjects.
- Subjects must be scheduled to undergo total knee arthroplasty under general anesthesia with consent for a femoral and sciatic nerve block post operatively for pain control.
- American Society of Anesthesiology Class 1,2,3,or 4.
- Capable of speaking and understanding English sufficiently to provide written informed consent and able to respond when asked.
- Weight > or equal to 60kg.
Who cannot join
- Any allergies or hypersensitivity to ropivacaine or dexamethasone.
- Subject is on chronic steroids preoperatively for any reason.
- History of chronic pain syndrome (i.e. CPRS, Lumbar radiculopathy).
- History of documented or stated nerve damage or neuropathy to the surgical lower extremity.
- Contraindication to placement of sciatic nerve block.
- Sciatic block placement failure.
- Subject mistakenly receives steroids intraoperatively.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Dexamethasone is a commonly used steroid. This medication has been used for many years by physicians for many different indications. Recent articles, multiple case reports, and experience at this institution have indicated that dexamethasone successfully prolongs the effective duration of local anesthetics for regional blocks. This can cause a significant reduction in postoperative pain and the decreased need for postoperative narcotics. Although other adjuncts can be used for prolonging nerve blocks, epinephrine causes local vasoconstriction which can cause ischemia and nerve damage in a large nerve such as the sciatic nerve.Dexamethasone will not cause this problem and yet could prolong the duration of a sciatic nerve block. Therefore, the goal of this study is to prospectively evaluate the effectiveness of dexamethasone, both locally through the nerve block and systemically via IV administration, in prolonging the effective duration of local anesthetics when used in sciatic nerve blocks.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Ropivacaine, Dexamethasone, Normal Saline
- Keywords
- Total Knee Arthroplasty., Sciatic nerve Blocks., Dexamethasone.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
20 ml of 0.2% ropivacaine injected locally as regional anesthesia given once.
DexamethasoneDrug
8mg Dexamethasone injected locally along with ropivacaine for regional anesthesia given once.
DexamethasoneDrug
2ml(8mg)Dexamethasone given once intravenously.
Normal SalineDrug
2ml of normal saline given once intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline. Receives: Drug: Ropivacaine; Drug: Normal Saline |
| Group B | Experimental | Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline. Receives: Drug: Ropivacaine; Drug: Dexamethasone; Drug: Normal Saline |
| Group C | Active comparator | Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone. Receives: Drug: Ropivacaine; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Sciatic Nerve Block
Intraoperative opioid requirement PACU opioid requirement Floor opioid usage Time of onset of motor block (or weakness) Time of onset of sensory block Return of motor function Return of sensation Pain scores
Measured: from the time the block was placed up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startAug 2007
- Primary completionJan 2011
- Study completionMay 2011
Why it stopped: PI is no longer here.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Lee, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616603
- Sponsor's protocol ID
- 57164
- Status last verified
- Jun 2014
- First submitted
- 4 Feb 2008
- Last updated
- 11 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks
- ClinicalTrials.gov ID
- NCT00616603
- Acronym / sponsor ID
- 57164
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty., Sciatic nerve Blocks., Dexamethasone.
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI is no longer here.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Posted 11 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dexamethasone is a commonly used steroid. This medication has been used for many years by physicians for many different indications. Recent articles, multiple case reports, and experience at this institution have indicated that dexamethasone successfully prolongs the effective duration of local anesthetics for regional blocks. This can cause a significant reduction in postoperative pain and the decreased need for postoperative narcotics. Although other adjuncts can be used for prolonging nerve blocks, epinephrine causes local vasoconstriction which can cause ischemia and nerve damage in a large nerve such as the sciatic nerve.Dexamethasone will not cause this problem and yet could prolong the duration of a sciatic nerve block. Therefore, the goal of this study is to prospectively evaluate the effectiveness of dexamethasone, both locally through the nerve block and systemically via IV administration, in prolonging the effective duration of local anesthetics when used in sciatic nerve blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Drug: Ropivacaine, Drug: Normal SalineThis is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline. |
| Group B | Experimental | Drug: Ropivacaine, Drug: Dexamethasone, Drug: Normal SalineSubjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline. |
| Group C | Active comparator | Drug: Ropivacaine, Drug: DexamethasoneSubjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 yrs, male or female subjects.
- Subjects must be scheduled to undergo total knee arthroplasty under general anesthesia with consent for a femoral and sciatic nerve block post operatively for pain control.
- American Society of Anesthesiology Class 1,2,3,or 4.
- Capable of speaking and understanding English sufficiently to provide written informed consent and able to respond when asked.
- Weight > or equal to 60kg.
Key exclusion criteria (7 listed)
- Any allergies or hypersensitivity to ropivacaine or dexamethasone.
- Subject is on chronic steroids preoperatively for any reason.
- History of chronic pain syndrome (i.e. CPRS, Lumbar radiculopathy).
- History of documented or stated nerve damage or neuropathy to the surgical lower extremity.
- Contraindication to placement of sciatic nerve block.
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 |
|---|---|---|
| Ropivacaine20 ml of 0.2% ropivacaine injected locally as regional anesthesia given once. | Drug | Group A, Group B, Group C |
| Dexamethasone8mg Dexamethasone injected locally along with ropivacaine for regional anesthesia given once. | Drug | Group B |
| Dexamethasone2ml(8mg)Dexamethasone given once intravenously. | Drug | Group C |
| Normal Saline2ml of normal saline given once intravenously. | Drug | Group A, Group B |
Primary outcome
Duration of Sciatic Nerve Block
Time frame: from the time the block was placed up to 24 hours
Intraoperative opioid requirement PACU opioid requirement Floor opioid usage Time of onset of motor block (or weakness) Time of onset of sensory block Return of motor function Return of sensation Pain scores
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Charles Lee, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine, Dexamethasone and Normal Saline in people with Total Knee Arthroplasty, run by Loma Linda University at 1 site in United States.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 11 Jun 2014. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 11 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Duration of Sciatic Nerve Block (time frame: from the time the block was placed up to 24 hours). 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 11 Jun 2014.