Carpal Tunnel Syndrome
Conditions
Brief summary
This pilot study will evaluate the latency of onset and duration of sensory-motor block in patients undergoing hand surgery. Patients will be randomized to receive nerve blocks of the distal forearm or of the distal and proximal forearm. Local anesthetic will be injected to anesthetise the median and ulnar nerves in the distal forearm (1-injection site group) or the median and ulnar nerves in the distal and proximal forearm (2-sequential injection sites group) to accomplish anesthesia for surgery on the hand.
Interventions
DRUGLidocaine
lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
DRUGBupivacaine
Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
Sponsors
New York School of Regional Anesthesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Scheduled to undergo daycare surgery for carpal tunnel syndrome under peripheral nerve blocks * American Society of Anesthesiologists (ASA) physical status I, II or III * Able to demonstrate sensory function in the ulnar and median nerve distribution by exhibiting sensitivity to cold, pinprick and light touch * Scheduled to undergo primary hand surgery * Able to understand the Dutch language, purpose and risks of the study * Able to provide informed consent and authorization to use protected health information, adhere to the study visit schedule, and complete all study assessments
Exclusion criteria
* Currently pregnant or nursing * History of hypersensitivity to local anesthetics * Contraindication to lidocaine, bupivacaine, paracetamol * Medical condition that will make it difficult to assess sensory distributions of the upper extremity peripheral nerves or to communicate with staff * Suspected or known recent history (\< 3 months) of drug or alcohol abuse * Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to Carpal Tunnel Syndrome and which may confound the postsurgical assessments * Infection at the planned block site(s) * Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®) * Body weight \<40 kg or body mass index \>44 kg/m2 * Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments * Any chronic neuromuscular deficit affecting the Ulnar and Median nerves or muscles of the surgical extremity * Any chronic condition or disease that would compromise neurological * Presence of pre-existing coagulation disorders * Baseline neurological deficits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves | 5-minute beginning at the end of the last injection | Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative Numeric Rating Scale (NRS) | screening Day0 (prior to the nerve block), post block, PACU arrival, Day0 evening, Day1 morning and evening, Day2 morning and evening, Day3 morning and evening, Day4, Day5, Day6, Day7 | pain rating(numeric rating scale) at rest and with movement ( scale 0:no pain - 10:worst pain) |
Countries
Belgium
Outcome results
None listed