AnesthesiaPhase 4NCT01603680
Distribution Circumferential Versus Non Circumferential of Mepivacaine in the Median and Ulnar Nerves
A Phase 4 study testing Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbow and Non circumferential spread in ultrasound-guided median and ulnar nerves block in people with Anesthesia, run by Complexo Hospitalario Universitario de A Coruña at 1 site in Spain.
Trial summary
1. Evaluation of the efficacy of the circumferential versus non circumferential distribution of mepivacaine around the median and ulnar nerves. 2. Evaluation the onset of action of mepivacaine in circumferential versus non circumferential distribution around the median and ulnar nerves. 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbow and Non circumferential spread in ultrasound-guided median and ulnar nerves block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Jul 2015
- 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
- Scheduled patients for surgery of carpal tunnel including patients in ASA I-III status, without exclusion criteria. The principal investigator study and/or other designated site staff will obtain written informed consent from all research patients.
Who cannot join
- Abnormal bleeding, infection in the punction side, allergy or other problems with the medication of the study, muscular or nerve diseases, patients < 18 years old, pregnancy, cognitive disease or reject of the patient
Trial locations and contacts
1 site in 1 country.
Spain1 site
Complexo Hospitalario Universitario A Coruña. Hospital Abente y Lago
A Coruña, A Coruña, 15006
About this study
Official title: Circumferential Versus Not Circumferential Distribution of Mepivacaine Around the Median and Ulnar Nerves in the Carpal Tunnel Surgery. Randomized Clinical Trial, Double Blinded.
- Evaluation of the efficacy of the circumferential versus non circumferential distribution of mepivacaine around the median and ulnar nerves.
- Evaluation the onset of action of mepivacaine in circumferential versus non circumferential distribution around the median and ulnar nerves.
- Spread of mepivacaine after injection guided by ultrasonography.
- Complications of both anesthetic techniques in postoperative time.
- Conditions
- Anesthesia
- Being tested
- Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbow, Non circumferential spread in ultrasound-guided median and ulnar nerves block
- Keywords
- Ultrasonography, Block nerve, Anaesthesia, Carpal tunnel syndrome
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbowProcedure or surgery
Also called Local anesthetic spread, "Doughnut sign"
Homogeneous spread of 6 ml of mepivacaine 1% around the median and ulnar nerves in each one using several needle passes and active hydrodissection
Non circumferential spread in ultrasound-guided median and ulnar nerves blockProcedure or surgery
Also called Asymmetric local anesthetic spread
Asymmetric spread of 6 ml of mepivacaine 1% in contact with median and ulnar nerves block in each one, using only one needle pass
| Study group | Role | What they receive |
|---|---|---|
| Circumferential (C) | Other | "Circumferential"(C) spread group will be defined as mepivacaine injectate visualized by ultrasonography all around the median and ulnar nerves imaged in short axis. Receives: Procedure: Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbow |
| Non circumferential (NC) | Other | Local anesthetic spread will be asymmetrical around the median and ulnar nerves, the mepivacaine will be partially in contact with the nerve Receives: Procedure: Non circumferential spread in ultrasound-guided median and ulnar nerves block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and onset of action
Sensory block will be assessed as a loss of cold sensation elicited by a cold wet cotton swab in the areas of the medial and ulnar nerves by comparison with contralateral hand. Sensory block will be clasiffied as follows: 0, anesthesia; 1, hyposthesia; 2, normal sensation. Motor function will be tested as according to a modified Bromage score: 0, no motor blokade; 1, weak response against resistence; 2, complete motor blockade. Motor and sensory blockades will be assessed by a blinded observer at 5, 15, 30 mins after local anesthetic injection and on arrival in the recovery room.
Measured: On arrival in the recovery room
Secondary outcomes (1)
Complications in postoperative time
Since the nerve block to the hospital outcome will be registered potencial block-related complications. At the first postoperative day, each patient will be called by phone, to report the time at first onset of pain in the operative site and lack of residual postoperative neurologic symptoms, postoperative nausea and vomiting, and hospital readmission (for severity of pain or bleeding or other reasons)
Measured: 24 hours postoperative time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complexo Hospitalario Universitario de A Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Diéguez García, Complexo Hospitalario Universitario de A Coruña
- Investigators
- Paula Diéguez, Anesthetist, Principal investigator, Complexo Hospitalario Universitario A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603680
- Sponsor's protocol ID
- ArAL 11.1
- Other IDs
- 2011-002608-34
- Status last verified
- Aug 2015
- First submitted
- 16 Jan 2012
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Al-Nasser B, Hubert C, Negre M. Role of local anesthetic spread pattern and electrical stimulation in ultrasound-guided musculocutaneous nerve block. J Clin Anesth. 2010 Aug;22(5):334-9. doi: 10.1016/j.jclinane.2009.09.008.
PubMed 20650379Morau D, Levy F, Bringuier S, Biboulet P, Choquet O, Kassim M, Bernard N, Capdevila X. Ultrasound-guided evaluation of the local anesthetic spread parameters required for a rapid surgical popliteal sciatic nerve block. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):559-64. doi: 10.1097/AAP.0b013e3181fa6b60.
PubMed 20975475Dieguez-Garcia P, Lopez-Alvarez S, Juncal J, Lopez AM, Sala-Blanch X. Comparison of the effectiveness of circumferential versus non-circumferential spread in median and ulnar nerve blocks. A double-blind randomized clinical trial. Reg Anesth Pain Med. 2020 May;45(5):362-366. doi: 10.1136/rapm-2019-101157. Epub 2020 Mar 11.
PubMed 32165554
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circumferential Versus Not Circumferential Distribution of Mepivacaine Around the Median and Ulnar Nerves in the Carpal Tunnel Surgery. Randomized Clinical Trial, Double Blinded.
- ClinicalTrials.gov ID
- NCT01603680
- Acronym / sponsor ID
- ArAL 11.1
- Conditions
- Anesthesia
- Keywords
- Ultrasonography, Block nerve, Anaesthesia, Carpal tunnel syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Complexo Hospitalario Universitario de A CoruñaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 May 2012 (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.
- Evaluation of the efficacy of the circumferential versus non circumferential distribution of mepivacaine around the median and ulnar nerves.
- Evaluation the onset of action of mepivacaine in circumferential versus non circumferential distribution around the median and ulnar nerves.
- Spread of mepivacaine after injection guided by ultrasonography.
- Complications of both anesthetic techniques in postoperative time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circumferential (C) | Other | Procedure: Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbow"Circumferential"(C) spread group will be defined as mepivacaine injectate visualized by ultrasonography all around the median and ulnar nerves imaged in short axis. |
| Non circumferential (NC) | Other | Procedure: Non circumferential spread in ultrasound-guided median and ulnar nerves blockLocal anesthetic spread will be asymmetrical around the median and ulnar nerves, the mepivacaine will be partially in contact with the nerve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled patients for surgery of carpal tunnel including patients in ASA I-III status, without exclusion criteria. The principal investigator study and/or other designated site staff will obtain written informed consent from all research patients.
Key exclusion criteria (1 listed)
- Abnormal bleeding, infection in the punction side, allergy or other problems with the medication of the study, muscular or nerve diseases, patients < 18 years old, pregnancy, cognitive disease or reject of 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 |
|---|---|---|
| Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbowAlso: Local anesthetic spread, "Doughnut sign"Homogeneous spread of 6 ml of mepivacaine 1% around the median and ulnar nerves in each one using several needle passes and active hydrodissection | Procedure or surgery | Circumferential (C) |
| Non circumferential spread in ultrasound-guided median and ulnar nerves blockAlso: Asymmetric local anesthetic spreadAsymmetric spread of 6 ml of mepivacaine 1% in contact with median and ulnar nerves block in each one, using only one needle pass | Procedure or surgery | Non circumferential (NC) |
Primary outcome
Efficacy and onset of action
Time frame: On arrival in the recovery room
Sensory block will be assessed as a loss of cold sensation elicited by a cold wet cotton swab in the areas of the medial and ulnar nerves by comparison with contralateral hand. Sensory block will be clasiffied as follows: 0, anesthesia; 1, hyposthesia; 2, normal sensation. Motor function will be tested as according to a modified Bromage score: 0, no motor blokade; 1, weak response against resistence; 2, complete motor blockade. Motor and sensory blockades will be assessed by a blinded observer at 5, 15, 30 mins after local anesthetic injection and on arrival in the recovery room.
1 secondary outcome
Complications in postoperative time
Time frame: 24 hours postoperative time
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 4 Aug 2015.
- Results publication: PubMed 20650379Al-Nasser B, Hubert C, Negre M. Role of local anesthetic spread pattern and electrical stimulation in ultrasound-guided musculocutaneous nerve block. J Clin Anesth. 2010 Aug;22(5):334-9. doi: 10.1016/j.jclinane.2009.09.008.
- Results publication: PubMed 20975475Morau D, Levy F, Bringuier S, Biboulet P, Choquet O, Kassim M, Bernard N, Capdevila X. Ultrasound-guided evaluation of the local anesthetic spread parameters required for a rapid surgical popliteal sciatic nerve block. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):559-64. doi: 10.1097/AAP.0b013e3181fa6b60.
- Derived from this study: PubMed 32165554Dieguez-Garcia P, Lopez-Alvarez S, Juncal J, Lopez AM, Sala-Blanch X. Comparison of the effectiveness of circumferential versus non-circumferential spread in median and ulnar nerve blocks. A double-blind randomized clinical trial. Reg Anesth Pain Med. 2020 May;45(5):362-366. doi: 10.1136/rapm-2019-101157. Epub 2020 Mar 11.
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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.
Paula Diéguez, Anesthetist principal investigator
Complexo Hospitalario Universitario A Coruña
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 Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbow and Non circumferential spread in ultrasound-guided median and ulnar nerves block in people with Anesthesia, run by Complexo Hospitalario Universitario de A Coruña at 1 site in Spain.
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 1 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 4 Aug 2015. 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 Spain. 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?
Efficacy and onset of action (time frame: On arrival in the recovery room). 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 NCT01603680, which also lists 3 linked publications.
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 4 Aug 2015.