Renal InsufficiencyNCT01323075
Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)
An observational study of Renal Insufficiency and Diabetes, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
The primary objective is to demonstrate a longer period of neurologic recovery from a sensory block assessed in each test group versus the group without metabolic disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Insufficiency, Diabetes
- What is being tested?
- Truncal block
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 3 sitesFrance
- Study dates
- May 2011to 13 Dec 2013
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Three patient populations schelduled for surgery on the hand or wrist. The three groups include (1) patients with no metabolic or neurologic disease history, (2) patients with renal insufficiency but not diabetes and (3) patients with diabetes but not renal insufficiency.
Who may be able to join
- Patient has renal insufficiency as defined by a creatine clearance of < 30ml/min without dialysis
- Patient has chronic hyperglycemia, either a fasting glycemia > 1.26 g/l (7mmol/l) for longer than 5 years and receiving an oral, well-adjusted (last HBA1c < 6.5%)), non-insulin, antidiabetic treatment
- Patient without metabolic or neurologic disease, with creating clearance > 90ml/min
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant
Show all 14Show fewer
- The patient is breastfeeding
- Patient weighs less than 50 kg
- Score ASA > 4
- contra indication for locoregional anesthesia
- Severe metabolic and / or decompensated renal disease, cardiac or pulmonary decompensation
- Associated peripheral neuropathy associated with diabetes or kidney disease
- Associated central neuropathy associated (eg MS ... narrow cervical canal)
- Patients with both renal failure and diabetes
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Lapeyronnie CHU de Montpellier
Montpellier, 34295
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, 30029
Hôpital Privé Claude Galien
Quincy-sous-Sénart, 91480
About this study
The primary objective is to demonstrate a longer period of neurologic recovery from a sensory block assessed in each test group versus the group without metabolic disease.
- Conditions
- Renal Insufficiency, Diabetes
- Being tested
- Truncal block
- Medical subject headings
- Renal Insufficiency, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truncal blockProcedure or surgery
Patients will have a truncal block during hand or wrist surgery.
| Study group | Role | What they receive |
|---|---|---|
| Renal insufficiency group | Patients in this group have renal insufficiency as defined by a creatinine clearance of < 30 ml/min without dialysis. These patients do not have diabetes. Receives: Procedure: Truncal block | |
| Diabetic group | These patients have diabetes, but not renal insufficiency. Receives: Procedure: Truncal block | |
| Non-exposed group | These patients have neither a neurological nor a metabolic disease and a creatine clearance of > 90 ml/min Receives: Procedure: Truncal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of sensory block in minutes.
The duration of the sensory block in minutes. The beginning of this term is defined by the end of the axillary block (last injection), and the end of this period is defined by the reappearance of sensitivity to touch in the area anesthetized.
Measured: Day 0 (per-op)
Secondary outcomes (6)
Time necessary for completion of axillary blocks (1 / 3 upper humerus)(min)
Measured: Day 0 (per-op)
Time necessary for installing sensory and motor block (min)
Time necessary for installing sensory and motor block (min): defined by the delay between the end of the block injection and the occurrence of insensitivity of blocked territories
Measured: Day 0 (per-op)
Failure of the block: yes / no
Failure of the block: yes / no: defined by an absence of sensory block
Measured: Day 0 (per-op)
Presence of paresthesia: yes / no
Measured: Day 0 (per-op)
Occurrence of neurological complications, yes/no
Neurological: occurrence of complications (paresthesia, paralysis, paresis ....) that persist (or not) until the final postoperative evaluation
Measured: Day 0 (post-op)
Occurrence of neurological complications, yes/no
Occurrence of neurological complications (paresthesia, paralysis, paresis ....)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startMay 2011
- Primary completion13 Dec 2013
- Study completion13 Dec 2013
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 Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Cuvillon, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323075
- Sponsor's protocol ID
- LOCAL/2010/PC-02
- Other IDs
- 2010-024519-15
- Status last verified
- Mar 2015
- First submitted
- 24 Mar 2011
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Cuvillon P, Casier M, Demattei C, Bernard N, Boisson C, Vialles N, Lhermite J, Ripart J, Capdevila X. Comparison of axillary nerve block duration using mepivacaine in non-insulin diabetic or renal insufficiency patients: a controlled observational matched multicenter trial. Minerva Anestesiol. 2019 Feb;85(2):124-132. doi: 10.23736/S0375-9393.18.12322-4. Epub 2018 Mar 27.
PubMed 29589414
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)
- ClinicalTrials.gov ID
- NCT01323075
- Acronym / sponsor ID
- LOCAL/2010/PC-02
- Conditions
- Renal Insufficiency, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- 13 Dec 2013 (actual)
- Study completion
- 13 Dec 2013 (actual)
- First posted
- 25 Mar 2011 (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 primary objective is to demonstrate a longer period of neurologic recovery from a sensory block assessed in each test group versus the group without metabolic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Renal insufficiency group | – | Procedure: Truncal blockPatients in this group have renal insufficiency as defined by a creatinine clearance of < 30 ml/min without dialysis. These patients do not have diabetes. |
| Diabetic group | – | Procedure: Truncal blockThese patients have diabetes, but not renal insufficiency. |
| Non-exposed group | – | Procedure: Truncal blockThese patients have neither a neurological nor a metabolic disease and a creatine clearance of > 90 ml/min |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Three patient populations schelduled for surgery on the hand or wrist. The three groups include (1) patients with no metabolic or neurologic disease history, (2) patients with renal insufficiency but not diabetes and (3) patients with diabetes but not renal insufficiency.
Key inclusion criteria (3 listed)
- Patient has renal insufficiency as defined by a creatine clearance of < 30ml/min without dialysis
- Patient has chronic hyperglycemia, either a fasting glycemia > 1.26 g/l (7mmol/l) for longer than 5 years and receiving an oral, well-adjusted (last HBA1c < 6.5%)), non-insulin, antidiabetic treatment
- Patient without metabolic or neurologic disease, with creating clearance > 90ml/min
Key exclusion criteria (14 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| Truncal blockPatients will have a truncal block during hand or wrist surgery. | Procedure or surgery | Diabetic group, Non-exposed group, Renal insufficiency group |
Primary outcome
The duration of sensory block in minutes.
Time frame: Day 0 (per-op)
The duration of the sensory block in minutes. The beginning of this term is defined by the end of the axillary block (last injection), and the end of this period is defined by the reappearance of sensitivity to touch in the area anesthetized.
6 secondary outcomes
Time necessary for completion of axillary blocks (1 / 3 upper humerus)(min)
Time frame: Day 0 (per-op)
Time necessary for installing sensory and motor block (min)
Time frame: Day 0 (per-op)
Failure of the block: yes / no
Time frame: Day 0 (per-op)
Presence of paresthesia: yes / no
Time frame: Day 0 (per-op)
Occurrence of neurological complications, yes/no
Time frame: Day 0 (post-op)
Occurrence of neurological complications, yes/no
Time frame: 1 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 17 Nov 2025.
- Results publication: PubMed 29589414Cuvillon P, Casier M, Demattei C, Bernard N, Boisson C, Vialles N, Lhermite J, Ripart J, Capdevila X. Comparison of axillary nerve block duration using mepivacaine in non-insulin diabetic or renal insufficiency patients: a controlled observational matched multicenter trial. Minerva Anestesiol. 2019 Feb;85(2):124-132. doi: 10.23736/S0375-9393.18.12322-4. Epub 2018 Mar 27.
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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.
Philippe Cuvillon, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency and Diabetes, run by Centre Hospitalier Universitaire de Nīmes at 3 sites 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 3 inclusion and 14 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
The duration of sensory block in minutes. (time frame: Day 0 (per-op)). 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 NCT01323075, 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 17 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.