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

Anesthesia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603680
• Other study ID #: ArAL 11.1
• Secondary ID: 2011-002608-34
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2012
• Last updated: August 3, 2015
• Start date: January 2012
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Complexo Hospitalario Universitario de A Coruña
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical 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. Spread of mepivacaine after injection guided by ultrasonography.

4. Complications of both anesthetic techniques in postoperative time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

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 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

Locations

Country	Name	City	State
Spain	Complexo Hospitalario Universitario A Coruña. Hospital Abente y Lago	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Complexo Hospitalario Universitario de A Coruña

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Al-Nasser B, Hubert C, Négre 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. — View Citation

Morau 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	On arrival in the recovery room	Yes
Secondary	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)	24 hours postoperative time	Yes