Circumferential Versus Not Circumferential Distribution of Mepivacaine Around the Median and Ulnar Nerves in the Carpal Tunnel Surgery. Randomized Clinical Trial, Double Blinded.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Efficacy and onset of action
Study Overview
Brief Summary
- 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Exclusion Criteria:
- •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
Arms & Interventions
Circumferential (C)
"Circumferential"(C) spread group will be defined as mepivacaine injectate visualized by ultrasonography all around the median and ulnar nerves imaged in short axis.
Intervention: Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbow (Procedure)
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
Intervention: Non circumferential spread in ultrasound-guided median and ulnar nerves block (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Complications in postoperative time(24 hours postoperative time)
Investigators
Paula Diéguez García
Principal Investigator
Complexo Hospitalario Universitario de A Coruña