Postoperative PainPhase 4NCT02526199
Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery
A Phase 4 study testing Bupivacaine, Epinephrine and Dexamethasone in people with Postoperative Pain, run by Rasmus Wulff Hauritz at 1 site in Denmark.
Trial summary
To extend the duration of peripheral nerve blockade after major foot and ankle surgery the investigators randomize the postoperative treatment with either perineurial sciatic nerve blocks with 0.5% Bupivacaine-Epinephrine with or without Dexamethasone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine, Epinephrine and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Jul 2016
- Phase
- Phase 4
- 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
- age > 17
- scheduled major foot and ankle surgery
- written informed consent
- fertile women in anti conceptive treatment
- fertile women not in anti conceptive treatment, but with negative urin-HCG on day of surgery
Who cannot join
- patients not able to understand or cooperate
- allergies to medicines involved
- daily buse of steroids
- daily use of opioids
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anesthesia, Aarhus University Hospital
Aarhus, Region Midt, 8000
About this study
Official title: Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery. A Randomized Double-blind, Controlled Study Comparing Bupivacaine-Epinephrine 0.5% Versus Bupivacaine-Epinephrine 0.5% With Dexamethasone
To extend the duration of peripheral nerve blockade after major foot and ankle surgery the investigators randomize the postoperative treatment with either perineurial sciatic nerve blocks with 0.5% Bupivacaine-Epinephrine with or without Dexamethasone.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine, Epinephrine, Dexamethasone
- Keywords
- Local anesthetics, Perineural nerve blocks, Perineurial Dexamethasone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
Sciatic nerve block
EpinephrineDrug
Also called Adrenaline
Adjuvant to perinerual block
DexamethasoneDrug
Also called Deaxagalene
Adjuvant to perinerual block
| Study group | Role | What they receive |
|---|---|---|
| Group BA | Active comparator | Bupivacaine + Adrenaline Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml Receives: Drug: Bupivacaine; Drug: Epinephrine |
| Group BAD | Experimental | Bupivacine + Adrenaline + Dexamethasone Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml PLUS Dexamethsone 8 mg Receives: Drug: Bupivacaine; Drug: Epinephrine; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Painfree period (time until first pain sensation in operated foot)
Patients are closely monitored in the PACU until first pain sensation in the operated foot.
Measured: 48 hours
Secondary outcomes (4)
Pain in the operated foot, measured on a numeric rating scale (0-10)
Pain score at rest, with the operated foot elevated on a pillow, ranging from 0 [no pain] to 10 [worst possible pain]
Measured: Every 30 minuttes from the patient enters the PACU to the nerve block wears of
Sensibility score, measured with a hided tactile pinprick-sensation under the 3.rd toe on the operated foot
Sensitivy score measured on a 3 point scale 0 (no sensation) (impared sensation) 2 (full or normal sensation) compared to non-operated side
Measured: Every 30 minutes from the patient enters the PACU to the sensations core reach 2
Total consumption of opioids during the length of stay
A cummulative calculation of equipotente doses of oral milligrams of morphin during the length of stay
Measured: 48 hours
quality of sleep first night measured on a 3 point scale
Quality of sleep measured on the morning after operation. 0 (good sleep, no interruptions) by pain from operated foot) 1 (sleep, but interruption without pain) 2 (sleep but interrupted by pain from operated foot)
Measured: hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rasmus Wulff Hauritz
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Rasmus Wulff Hauritz, Kolding Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526199
- Sponsor's protocol ID
- 2014-005383-14
- Other IDs
- 2014
- Status last verified
- Sep 2016
- First submitted
- 11 Aug 2015
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery. A Randomized Double-blind, Controlled Study Comparing Bupivacaine-Epinephrine 0.5% Versus Bupivacaine-Epinephrine 0.5% With Dexamethasone
- ClinicalTrials.gov ID
- NCT02526199
- Acronym / sponsor ID
- 2014-005383-14
- Conditions
- Postoperative Pain
- Keywords
- Local anesthetics, Perineural nerve blocks, Perineurial Dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Rasmus Wulff HauritzUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Aug 2015 (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.
To extend the duration of peripheral nerve blockade after major foot and ankle surgery the investigators randomize the postoperative treatment with either perineurial sciatic nerve blocks with 0.5% Bupivacaine-Epinephrine with or without Dexamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group BA | Active comparator | Drug: Bupivacaine, Drug: EpinephrineBupivacaine + Adrenaline Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml |
| Group BAD | Experimental | Drug: Bupivacaine, Drug: Epinephrine, Drug: DexamethasoneBupivacine + Adrenaline + Dexamethasone Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml PLUS Dexamethsone 8 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 17
- scheduled major foot and ankle surgery
- written informed consent
- fertile women in anti conceptive treatment
- fertile women not in anti conceptive treatment, but with negative urin-HCG on day of surgery
Key exclusion criteria (4 listed)
- patients not able to understand or cooperate
- allergies to medicines involved
- daily buse of steroids
- daily use of opioids
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 |
|---|---|---|
| BupivacaineAlso: MarcaineSciatic nerve block | Drug | Group BA, Group BAD |
| EpinephrineAlso: AdrenalineAdjuvant to perinerual block | Drug | Group BA, Group BAD |
| DexamethasoneAlso: DeaxagaleneAdjuvant to perinerual block | Drug | Group BAD |
Primary outcome
Painfree period (time until first pain sensation in operated foot)
Time frame: 48 hours
Patients are closely monitored in the PACU until first pain sensation in the operated foot.
4 secondary outcomes
Pain in the operated foot, measured on a numeric rating scale (0-10)
Time frame: Every 30 minuttes from the patient enters the PACU to the nerve block wears of
Sensibility score, measured with a hided tactile pinprick-sensation under the 3.rd toe on the operated foot
Time frame: Every 30 minutes from the patient enters the PACU to the sensations core reach 2
Total consumption of opioids during the length of stay
Time frame: 48 hours
quality of sleep first night measured on a 3 point scale
Time frame: hours
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 Sep 2016.
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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 Phase 4 study testing Bupivacaine, Epinephrine and Dexamethasone in people with Postoperative Pain, run by Rasmus Wulff Hauritz at 1 site in Denmark.
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 4 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 Sep 2016. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Painfree period (time until first pain sensation in operated foot) (time frame: 48 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 23 Sep 2016.