PainPhase 4NCT02049255
Comparision of the Use in Marcaine and Chloroprocaine in Rachianesthesia for the Surgical Correction of Inguinal Hernia.
A Phase 4 study testing Chloroprocaine and Marcaine in people with Pain, run by Astes at 1 site in Belgium.
Trial summary
Comparison the use of marcaine and chloroprocaine in rachianesthesia for a surgical correction of inguinal hernia. Comparision between acute and chronic (3 months and 6 months) pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Chloroprocaine and Marcaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2013to Oct 2014
- 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
- Adults under rachianesthesia
Who cannot join
- Personal history of gastric ulcus
- ASA 4
- Emergency
- Combined surgery
Trial locations and contacts
1 site in 1 country.
About this study
Comparison the use of marcaine and chloroprocaine in rachianesthesia for a surgical correction of inguinal hernia. Comparision between acute and chronic (3 months and 6 months) pain.
- Conditions
- Pain
- Being tested
- Chloroprocaine, Marcaine
- Keywords
- All
- Medical subject headings
- Pain, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroprocaineDrug
The Group "Chloroprocaine" will receive: Chloroprocaine: 50 mg in rachianesthesia
MarcaineDrug
The Group "Marcaine" will receive: Marcaine: 12,5 mg in rachianesthesia
| Study group | Role | What they receive |
|---|---|---|
| Marcaine | Placebo comparator | Rachianesthesia with marcaine or chloroprocaine Receives: Drug: Marcaine |
| Chloroprocaine | Active comparator | Rachianesthesia with marcaine or chloroprocaine Receives: Drug: Chloroprocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute pain
Measured: 1 day of the surgery when patient leave the recovery room
Secondary outcomes (1)
Chronic pain
Measured: at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric DEFLANDRE, MD, FCCP, Astes
- Investigators
- Eric P Deflandre, MD, FCCP, Principal investigator, Astes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049255
- Sponsor's protocol ID
- AMBES-ASTES-2013
- Status last verified
- Oct 2014
- First submitted
- 24 Jan 2014
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision of the Use in Marcaine and Chloroprocaine in Rachianesthesia for the Surgical Correction of Inguinal Hernia.
- ClinicalTrials.gov ID
- NCT02049255
- Acronym / sponsor ID
- AMBES-ASTES-2013
- Conditions
- Pain
- Keywords
- All
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AstesUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Jan 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.
Comparison the use of marcaine and chloroprocaine in rachianesthesia for a surgical correction of inguinal hernia. Comparision between acute and chronic (3 months and 6 months) pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marcaine | Placebo comparator | Drug: MarcaineRachianesthesia with marcaine or chloroprocaine |
| Chloroprocaine | Active comparator | Drug: ChloroprocaineRachianesthesia with marcaine or chloroprocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults under rachianesthesia
Key exclusion criteria (4 listed)
- Personal history of gastric ulcus
- ASA 4
- Emergency
- Combined surgery
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 |
|---|---|---|
| ChloroprocaineThe Group "Chloroprocaine" will receive: Chloroprocaine: 50 mg in rachianesthesia | Drug | Chloroprocaine |
| MarcaineThe Group "Marcaine" will receive: Marcaine: 12,5 mg in rachianesthesia | Drug | Marcaine |
Primary outcome
Acute pain
Time frame: 1 day of the surgery when patient leave the recovery room
1 secondary outcome
Chronic pain
Time frame: at 3 and 6 months
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 3 Nov 2014.
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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.
Eric P Deflandre, MD, FCCP principal investigator
Astes
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 Chloroprocaine and Marcaine in people with Pain, run by Astes at 1 site in Belgium.
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 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 3 Nov 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 Belgium. 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.
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?
Acute pain (time frame: 1 day of the surgery when patient leave the recovery room). 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 3 Nov 2014.