Distribution Circumferential Versus Non Circumferential of Mepivacaine in the Median and Ulnar Nerves
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|ClinicalTrials.gov Identifier: NCT01603680|
Recruitment Status : Completed
First Posted : May 22, 2012
Last Update Posted : August 4, 2015
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia||Procedure: Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbow Procedure: Non circumferential spread in ultrasound-guided median and ulnar nerves block||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
"Circumferential"(C) spread group will be defined as mepivacaine injectate visualized by ultrasonography all around the median and ulnar nerves imaged in short axis.
Procedure: Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbow
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 (NC)
Local anesthetic spread will be asymmetrical around the median and ulnar nerves, the mepivacaine will be partially in contact with the nerve
Procedure: Non circumferential spread in ultrasound-guided median and ulnar nerves block
Asymmetric spread of 6 ml of mepivacaine 1% in contact with median and ulnar nerves block in each one, using only one needle pass
Other Name: Asymmetric local anesthetic spread
- 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.
- Complications in postoperative time [ Time Frame: 24 hours 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603680
|Complexo Hospitalario Universitario A Coruña. Hospital Abente y Lago|
|A Coruña, Spain, 15006|
|Principal Investigator:||Paula Diéguez, Anesthetist||Complexo Hospitalario Universitario A Coruña|