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Completed

NCT Number: NCT01603680

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

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.

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Key information

Conditions

Anesthesia Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Complexo Hospitalario Universitario A Coruña. Hospital Abente y Lago

A Coruña, 15006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbow

Procedure

Homogeneous spread of 6 ml of mepivacaine 1% around the median and ulnar nerves in each one using several needle passes and active hydrodissection

Other names: Local anesthetic spread, "Doughnut sign"

Non circumferential spread in ultrasound-guided median and ulnar nerves block

Procedure

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 names: Asymmetric local anesthetic spread

Primary outcomes

  1. 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

  1. 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)

Sponsors and collaborators

Lead sponsor

Complexo Hospitalario Universitario de A Coruña

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 22, 2012
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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