Hallux ValgusPhase 4NCT00600899
Home Infusors for Analgesia After Foot Surgery
A Phase 4 study testing elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/h and elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/h in people with Hallux Valgus, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial summary
The purpose of this double blind, randomized study is to evaluate which rate and duration of infusion can be recommended for continuous perisciatic infusion of ropivacaine 2 mg/ml for analgesia after ambulatory foot surgery. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/h and elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/h
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2008to Dec 2010
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All ambulatory patients (ASA 1-3) scheduled for foot and ankle surgery in spinal or general anesthesia that are willing to participate in the study after informed consent will be taken into consideration.
- Age span: 19 -80 years.
- When fertile females are included, we will make sure that they receive anticonceptive treatment.
Who cannot join
- Contraindications for sciatic catheter placement and allergy to local anesthetics.
- The patients with chronic pain receiving opioids, pregnant patients, those with rheumatoid arthritis, lever or heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Home Pumps for Analgesia After Ambulatory Foot Surgery - Comparison of Two Infusion Rates - a Randomized, Double-Blind Study
The purpose of this double blind, randomized study is to evaluate which rate and duration of infusion can be recommended for continuous perisciatic infusion of ropivacaine 2 mg/ml for analgesia after ambulatory foot surgery.
Read the detailed description
Protocol title:
Use of home pumps for analgesia after ambulatory foot surgery - comparison of two infusion rates SUMMARY in English
THE PURPOSE:
The purpose of this double blind, randomized study is to evaluate which rate and duration of infusion can be recommended for continuous perisciatic infusion of ropivacaine 2 mg/ml for analgesia after ambulatory foot surgery.
BACKGROUND:
In the previous study (1) we showed that the continuous perisciatic infusion of 2 mg/ml ropivacaine 5 ml/h for 55 hours provided better analgesia than placebo after ambulatory foot surgery. Similar results are reported by Singelyn (2), Ilfeld (3) and White (4). But, different pumps with different basal infusion rates were used in these studies. Singelyn used infusion rate of 7 ml/h for 48 hours, while Ilfeld used mechanical pump with adjustable infusion rate, starting with 8 ml/h and patient controlled analgesia (PCA) 2 ml/20 minutes for 2 postoperative days. In our and White's studies elastomeric pumps with reservoir of 500 ml and infusion rate of 5 ml/h were used in 55 hours. Capdevila (5) has shown that the patients prefer elastomeric pumps because they cause fewer problems. That is why it will be our choice as well.
The analgesic efficacy in our study was good as the patients in the treatment group had less pain and fewer sleep disturbances than in the placebo group. The question is whether higher infusion rate and longer duration would have an even better effect.
The aim of this study is to compare (in a double blind manner) two different regimens for continuous perisciatic nerve infusion of ropivacaine 2 mg/ml after ambulatory foot surgery:
- elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/h (duration 55 hours) and
- elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/h (duration 62 hours).
Design:
A randomized, double blind study with 40 ambulatory patients who will undergo foot or ankle surgery. These patients will be randomized to receive either regimen 1. (5 ml/h for 55 hours) or regimen 2. (8 ml/h for 62 hours). The randomization procedure: sequentially numbered, sealed, opaque envelopes that contain computer produced random numbers for treatment allocation. Blinding procedures: pre-numbered identical containers marked with "Test drug", date of production and infusion start/end will be provided by the registered nurse (SK). The patient and the acute pain nurse (EB), who will evaluate the effect of these two treatments, will be blinded.
On each of the 3 postoperative days the patients will be contacted by phone by the acute pain nurse and a standard questionnaire will be completed.
The primary effect variable is worst pain on the first postoperative day evaluated as VAS score.
- Conditions
- Hallux Valgus
- Being tested
- elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/h, elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/h
- Keywords
- Postoperative pain treatment
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/hProcedure or surgery
Continuous perisciatic infusion of ropivacaine 2mg/ml (Baxter infusor with 500 ml reservoir and infusion rate of 8 ml/h)
elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/hProcedure or surgery
Continuous perisciatic infusion of ropivacaine 2mg/ml (Baxter infusor with 275 ml reservoir and infusion rate of 5ml/h)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Group A patients will receive perisciatic continuous infusion of ropivacaine 2 mg/ml through an elastomeric pump (Baxter, Deerfield, IL, USA)) 8 ml/h (reservoir of 500 ml)as postoperative analgesia. Receives: Procedure: elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/h |
| B | Active comparator | Group B patients will receive standard treatment: continuous perisciatic infusion of 2 mg/ml ropivacaine 5 ml/t (Baxter infusor with 275 ml reservoir) Receives: Procedure: elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/h |
What is being measured
The primary outcome is the main question the study is designed to answer.
worst pain
Measured: first postoperative day
Secondary outcomes (3)
Average pain
Measured: 1st, 2nd and 3rd postoperative days
Opioid consumption
Measured: first, second and third postoperative days
Side effects
Measured: 1st, 2nd and 3rd postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies 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, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dusanka Zaric, MD pHd, Principal investigator, Ndr. Fasanvej 57 2000 Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600899
- Sponsor's protocol ID
- EudraCT2007-005180-10
- Other IDs
- 9445-DZ
- Status last verified
- Jan 2009
- First submitted
- 14 Jan 2008
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zaric D, Boysen K, Christiansen J, Haastrup U, Kofoed H, Rawal N. Continuous popliteal sciatic nerve block for outpatient foot surgery--a randomized, controlled trial. Acta Anaesthesiol Scand. 2004 Mar;48(3):337-41. doi: 10.1111/j.0001-5172.2004.0327.x.
PubMed 14982567
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Home Pumps for Analgesia After Ambulatory Foot Surgery - Comparison of Two Infusion Rates - a Randomized, Double-Blind Study
- ClinicalTrials.gov ID
- NCT00600899
- Acronym / sponsor ID
- EudraCT2007-005180-10
- Conditions
- Hallux Valgus
- Keywords
- Postoperative pain treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 25 Jan 2008 (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 purpose of this double blind, randomized study is to evaluate which rate and duration of infusion can be recommended for continuous perisciatic infusion of ropivacaine 2 mg/ml for analgesia after ambulatory foot surgery.
Detailed description
Protocol title:
Use of home pumps for analgesia after ambulatory foot surgery - comparison of two infusion rates SUMMARY in English
THE PURPOSE:
The purpose of this double blind, randomized study is to evaluate which rate and duration of infusion can be recommended for continuous perisciatic infusion of ropivacaine 2 mg/ml for analgesia after ambulatory foot surgery.
BACKGROUND:
In the previous study (1) we showed that the continuous perisciatic infusion of 2 mg/ml ropivacaine 5 ml/h for 55 hours provided better analgesia than placebo after ambulatory foot surgery. Similar results are reported by Singelyn (2), Ilfeld (3) and White (4). But, different pumps with different basal infusion rates were used in these studies. Singelyn used infusion rate of 7 ml/h for 48 hours, while Ilfeld used mechanical pump with adjustable infusion rate, starting with 8 ml/h and patient controlled analgesia (PCA) 2 ml/20 minutes for 2 postoperative days. In our and White's studies elastomeric pumps with reservoir of 500 ml and infusion rate of 5 ml/h were used in 55 hours. Capdevila (5) has shown that the patients prefer elastomeric pumps because they cause fewer problems. That is why it will be our choice as well.
The analgesic efficacy in our study was good as the patients in the treatment group had less pain and fewer sleep disturbances than in the placebo group. The question is whether higher infusion rate and longer duration would have an even better effect.
The aim of this study is to compare (in a double blind manner) two different regimens for continuous perisciatic nerve infusion of ropivacaine 2 mg/ml after ambulatory foot surgery:
- elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/h (duration 55 hours) and
- elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/h (duration 62 hours).
Design:
A randomized, double blind study with 40 ambulatory patients who will undergo foot or ankle surgery. These patients will be randomized to receive either regimen 1. (5 ml/h for 55 hours) or regimen 2. (8 ml/h for 62 hours). The randomization procedure: sequentially numbered, sealed, opaque envelopes that contain computer produced random numbers for treatment allocation. Blinding procedures: pre-numbered identical containers marked with "Test drug", date of production and infusion start/end will be provided by the registered nurse (SK). The patient and the acute pain nurse (EB), who will evaluate the effect of these two treatments, will be blinded.
On each of the 3 postoperative days the patients will be contacted by phone by the acute pain nurse and a standard questionnaire will be completed.
The primary effect variable is worst pain on the first postoperative day evaluated as VAS score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/hGroup A patients will receive perisciatic continuous infusion of ropivacaine 2 mg/ml through an elastomeric pump (Baxter, Deerfield, IL, USA)) 8 ml/h (reservoir of 500 ml)as postoperative analgesia. |
| B | Active comparator | Procedure: elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/hGroup B patients will receive standard treatment: continuous perisciatic infusion of 2 mg/ml ropivacaine 5 ml/t (Baxter infusor with 275 ml reservoir) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All ambulatory patients (ASA 1-3) scheduled for foot and ankle surgery in spinal or general anesthesia that are willing to participate in the study after informed consent will be taken into consideration.
- Age span: 19 -80 years.
- When fertile females are included, we will make sure that they receive anticonceptive treatment.
Key exclusion criteria (2 listed)
- Contraindications for sciatic catheter placement and allergy to local anesthetics.
- The patients with chronic pain receiving opioids, pregnant patients, those with rheumatoid arthritis, lever or heart disease.
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 |
|---|---|---|
| elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/hContinuous perisciatic infusion of ropivacaine 2mg/ml (Baxter infusor with 500 ml reservoir and infusion rate of 8 ml/h) | Procedure or surgery | A |
| elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/hContinuous perisciatic infusion of ropivacaine 2mg/ml (Baxter infusor with 275 ml reservoir and infusion rate of 5ml/h) | Procedure or surgery | B |
Primary outcome
worst pain
Time frame: first postoperative day
3 secondary outcomes
Average pain
Time frame: 1st, 2nd and 3rd postoperative days
Opioid consumption
Time frame: first, second and third postoperative days
Side effects
Time frame: 1st, 2nd and 3rd postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
- Background: PubMed 14982567Zaric D, Boysen K, Christiansen J, Haastrup U, Kofoed H, Rawal N. Continuous popliteal sciatic nerve block for outpatient foot surgery--a randomized, controlled trial. Acta Anaesthesiol Scand. 2004 Mar;48(3):337-41. doi: 10.1111/j.0001-5172.2004.0327.x.
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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.
Dusanka Zaric, MD pHd principal investigator
Ndr. Fasanvej 57 2000 Frederiksberg
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 elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/h and elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/h in people with Hallux Valgus, run by Frederiksberg University Hospital 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Jan 2009. 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?
Results are not available in the source record.
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?
worst pain (time frame: first postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00600899, which also lists 1 linked publication.
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 29 Jan 2009.