Skip to content

Distribution Circumferential Versus Non Circumferential of Mepivacaine in the Median and Ulnar Nerves

Circumferential Versus Not Circumferential Distribution of Mepivacaine Around the Median and Ulnar Nerves in the Carpal Tunnel Surgery. Randomized Clinical Trial, Double Blinded.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01603680
Enrollment
124
Registered
2012-05-22
Start date
2012-01-31
Completion date
2015-07-31
Last updated
2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Ultrasonography, Block nerve, Anaesthesia, Carpal tunnel syndrome

Brief 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. Spread of mepivacaine after injection guided by ultrasonography. 4. Complications of both anesthetic techniques in postoperative time.

Interventions

PROCEDURECircumferential 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

PROCEDURENon 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

Sponsors

Complexo Hospitalario Universitario de A Coruña
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy and onset of actionOn arrival in the recovery roomSensory 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

MeasureTime frameDescription
Complications in postoperative time24 hours postoperative timeSince 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)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026