AnalgesiaNCT02253784
Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of Four Nerve Blocks With Bupivacaine in Total Knee Arthroplasty
A study testing Dexamethasone and Bupivacaine in people with Analgesia and Pain, Postoperative, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block in total knee arthroplasty. The aim of this study is to determine whether this is a systemic or local effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Pain, Postoperative
- What is being tested?
- Dexamethasone and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2014to 30 Oct 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-surgical total knee arthroplasty patients
Who cannot join
- Skin infection near block site
- Allergy to local anesthetics
- Peripheral neuropathy
- Proven opioid dependency
- Coagulopathy
- Dementia
Trial locations and contacts
1 site in 1 country.
About this study
The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block in total knee arthroplasty. The aim of this study is to determine whether this is a systemic or local effect.
- Conditions
- Analgesia, Pain, Postoperative
- Being tested
- Dexamethasone, Bupivacaine
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
BupivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Group I (ISB-P) | Active comparator | Four nerve blocks with perineural injection of dexamethasone 0.1 mg/kg and bupivacaine 0.5% - 45 ml Receives: Drug: Dexamethasone; Drug: Bupivacaine |
| Group II (ISB-S) | Active comparator | Four nerve blocks with systemic injection of dexamethasone 0.1 mg/kg and bupivacaine 0.5% - 45 ml Receives: Drug: Dexamethasone; Drug: Bupivacaine |
| Group III (ISB-C) | Active comparator | Four nerve blocks without dexamethasone Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Perineural DxaM
Duration of motor and sensory block
Measured: One day
Secondary outcomes (1)
Efficacy of Systemic DxaM
Duration of motor and sensory block
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anatoly Stav, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253784
- Sponsor's protocol ID
- 14-XX-HYMC
- Status last verified
- Oct 2014
- First submitted
- 29 Sep 2014
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of Four Nerve Blocks With Bupivacaine in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02253784
- Acronym / sponsor ID
- 14-XX-HYMC
- Conditions
- Analgesia, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 1 Oct 2014 (estimated)
- 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.
The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block in total knee arthroplasty. The aim of this study is to determine whether this is a systemic or local effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (ISB-P) | Active comparator | Drug: Dexamethasone, Drug: BupivacaineFour nerve blocks with perineural injection of dexamethasone 0.1 mg/kg and bupivacaine 0.5% - 45 ml |
| Group II (ISB-S) | Active comparator | Drug: Dexamethasone, Drug: BupivacaineFour nerve blocks with systemic injection of dexamethasone 0.1 mg/kg and bupivacaine 0.5% - 45 ml |
| Group III (ISB-C) | Active comparator | Drug: BupivacaineFour nerve blocks without dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pre-surgical total knee arthroplasty patients
Key exclusion criteria (6 listed)
- Skin infection near block site
- Allergy to local anesthetics
- Peripheral neuropathy
- Proven opioid dependency
- Coagulopathy
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 | Drug | Group I (ISB-P), Group II (ISB-S) |
| Bupivacaine | Drug | Group I (ISB-P), Group II (ISB-S), Group III (ISB-C) |
Primary outcome
Efficacy Perineural DxaM
Time frame: One day
Duration of motor and sensory block
1 secondary outcome
Efficacy of Systemic DxaM
Time frame: One day
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 31 Oct 2017.
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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.
Anatoly Stav, MD principal investigator
Hillel Yaffe Medical Center
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 and Bupivacaine in people with Analgesia and Pain, Postoperative, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 6 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 31 Oct 2017. 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 Israel. 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?
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?
Efficacy Perineural DxaM (time frame: One day). 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 31 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.