PainPhase 3LEVOBUNCT00621907
Study : LEVOBUPIVACAINE Versus Placebo
A Phase 3 study testing chirocaine (Levobupivacaine) and sodium chloride in people with Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The locoregional anaesthesia is increasingly important in surgical practice, often allowing to simplify per- and post-operative analgesia. caesarian occurs in 20 % of delivery leading to a longer hospitalization because of the pain resulting from the surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- chirocaine (Levobupivacaine) and sodium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to May 2009
- Phase
- Phase 3
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age > 18 years
- all patients requiring a non-urgent caesarian done according to the Misgav-Ladach technique
Who cannot join
- Patients requiring very urgent caesarian
- allergic to levobupivacaïne
- with previous history of alcoholism or drug addiction
- with severe hypotension or an ischemic cardiopathy badly compensated or thyrotoxicoses
- treated with first generation of IMAO (monoamine oxidase inhibitor) or with anti-arrhytmia drugs with anesthesic activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo
The locoregional anaesthesia is increasingly important in surgical practice, often allowing to simplify per- and post-operative analgesia. caesarian occurs in 20 % of delivery leading to a longer hospitalization because of the pain resulting from the surgery. The Levobupivacaïne (Chirocaïne) administered through catheters placed in the caesarean scars, showed its efficiency in post-operative analgesia.
Method : realization of a double blind prospective randomized study, control versus placebo Purpose : to show that the local administration of a unique dose of analgesia reduce the post-operative pain with a little or non-invasive technique
Read the detailed description
The study will be done at the department of Obstétric and gynecology, in the CHU of Saint-Etienne. It will include all patients requiring a caesarean without any contraindication.
All the patients requiring a urgent or a very urgent caesarean will be excluded because a rapid consent can't be obtained and the product preparation can't be done.
Inclusion after information and minimum one hour of time for consideration. Randomization : the teatment group will be randomized according to the patient number : control versus placebo : 70 patients in the group infiltration of levobupivacaïne and 70 patients in the group infiltration of a placebo. Every product will be prepared in a 30 ml syringe filled with levobupivacaïne or 0,9 % sodium chloride depending on the group of randomization. All patients will get their caesarean according to the same technique, then, before the cutaneous close, the product will be injected in the caesarean wall.
Fllow-up : supervision of the pain (morphine consumption, VAS) and of undesirable effects.
- Conditions
- Pain
- Being tested
- chirocaine (Levobupivacaine), sodium chloride
- Keywords
- randomized, analgesic, caesarean scars, locoregional anaesthesia, infiltration, levobupivacaïne, Chirocaïne, caesarian, unique administration, post-caesarian analgesic
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chirocaine (Levobupivacaine)Drug
levobupivacaine 0,5 % 30 ml infiltration (150 mg)
sodium chlorideDrug
sodium chloride : 0,9% 30 ml
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patient who received levobupivacaïne Receives: Drug: chirocaine (Levobupivacaine) |
| 2 | Placebo comparator | patient who received placebo Receives: Drug: sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic consumption of level 3 in the two treated groups
Measured: 24 hours
Secondary outcomes (1)
visual analogic scale (VAS) at rest or on rising, early rehabilitation, residual pain 2 months after the operation
Measured: hours : 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and at 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2009
- Study completionMay 2009
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Investigators
- Céline CHAULEUR, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621907
- Sponsor's protocol ID
- 0708097
- Other IDs
- 2007-006275-36
- Acronym
- LEVOBU
- Status last verified
- Sep 2010
- First submitted
- 11 Feb 2008
- Last updated
- 16 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Corsini T, Cuvillon P, Forgeot A, Chapelle C, Seffert P, Chauleur C. [Single-dose intraincisional levobupivacaine infiltration in caesarean postoperative analgesia: a placebo-controlled double-blind randomized trial]. Ann Fr Anesth Reanim. 2013 Jan;32(1):25-30. doi: 10.1016/j.annfar.2012.10.035. Epub 2012 Dec 21. French.
PubMed 23260628
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo
- ClinicalTrials.gov ID
- NCT00621907
- Acronym / sponsor ID
- LEVOBU / 0708097
- Conditions
- Pain
- Keywords
- randomized, analgesic, caesarean scars, locoregional anaesthesia, infiltration, levobupivacaïne, Chirocaïne, caesarian
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Feb 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 locoregional anaesthesia is increasingly important in surgical practice, often allowing to simplify per- and post-operative analgesia. caesarian occurs in 20 % of delivery leading to a longer hospitalization because of the pain resulting from the surgery. The Levobupivacaïne (Chirocaïne) administered through catheters placed in the caesarean scars, showed its efficiency in post-operative analgesia.
Method : realization of a double blind prospective randomized study, control versus placebo Purpose : to show that the local administration of a unique dose of analgesia reduce the post-operative pain with a little or non-invasive technique
Detailed description
The study will be done at the department of Obstétric and gynecology, in the CHU of Saint-Etienne. It will include all patients requiring a caesarean without any contraindication.
All the patients requiring a urgent or a very urgent caesarean will be excluded because a rapid consent can't be obtained and the product preparation can't be done.
Inclusion after information and minimum one hour of time for consideration. Randomization : the teatment group will be randomized according to the patient number : control versus placebo : 70 patients in the group infiltration of levobupivacaïne and 70 patients in the group infiltration of a placebo. Every product will be prepared in a 30 ml syringe filled with levobupivacaïne or 0,9 % sodium chloride depending on the group of randomization. All patients will get their caesarean according to the same technique, then, before the cutaneous close, the product will be injected in the caesarean wall.
Fllow-up : supervision of the pain (morphine consumption, VAS) and of undesirable effects.
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 |
|---|---|---|
| 1 | Experimental | Drug: chirocaine (Levobupivacaine)patient who received levobupivacaïne |
| 2 | Placebo comparator | Drug: sodium chloridepatient who received placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age > 18 years
- all patients requiring a non-urgent caesarian done according to the Misgav-Ladach technique
Key exclusion criteria (5 listed)
- Patients requiring very urgent caesarian
- allergic to levobupivacaïne
- with previous history of alcoholism or drug addiction
- with severe hypotension or an ischemic cardiopathy badly compensated or thyrotoxicoses
- treated with first generation of IMAO (monoamine oxidase inhibitor) or with anti-arrhytmia drugs with anesthesic activity
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 |
|---|---|---|
| chirocaine (Levobupivacaine)levobupivacaine 0,5 % 30 ml infiltration (150 mg) | Drug | 1 |
| sodium chloridesodium chloride : 0,9% 30 ml | Drug | 2 |
Primary outcome
analgesic consumption of level 3 in the two treated groups
Time frame: 24 hours
1 secondary outcome
visual analogic scale (VAS) at rest or on rising, early rehabilitation, residual pain 2 months after the operation
Time frame: hours : 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and at 2 month
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 16 Sep 2010.
- Derived from this study: PubMed 23260628Corsini T, Cuvillon P, Forgeot A, Chapelle C, Seffert P, Chauleur C. [Single-dose intraincisional levobupivacaine infiltration in caesarean postoperative analgesia: a placebo-controlled double-blind randomized trial]. Ann Fr Anesth Reanim. 2013 Jan;32(1):25-30. doi: 10.1016/j.annfar.2012.10.035. Epub 2012 Dec 21. French.
Related trials for Pain
Recruiting
Dry Needling in Multiple Sclerosis
Multiple Sclerosis
Active, not recruiting
A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors
Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
RecruitingPhase 3
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
Not yet recruitingPhase 4
Methylprednisolone Taper is an Effective Addition to Multimodal Pain Regimens After Rotator Cuff Repair
Shoulder
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.
Céline CHAULEUR, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chirocaine (Levobupivacaine) and sodium chloride in people with Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 2 inclusion and 5 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 16 Sep 2010. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
analgesic consumption of level 3 in the two treated groups (time frame: 24 hours). 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 NCT00621907, 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 16 Sep 2010.