Clinical trial NCT03649763: Onset and Duration of Forearm Nerve Blockade
Official title: Onset and Duration of Forearm Nerve Blockade Performed With a Single Distal Injection Versus Sequential Injections at Distal and Proximal Locations Alongside the Nerves: A Blinded Randomized
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carpal Tunnel Syndrome
Lead sponsor: New York School of Regional Anesthesia
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
timeFrame: 5-minute beginning at the end of the last injection
measure: onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
timeFrame: 10-minute beginning at the end of the last injection
measure: onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
timeFrame: 15-minute beginning at the end of the last injection
measure: onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
timeFrame: 20-minute beginning at the end of the last injection
measure: onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
timeFrame: 25-minute beginning at the end of the last injection
measure: onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
timeFrame: 30-minute beginning at the end of the last injection
measure: onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
timeFrame: 45-minute beginning at the end of the last injection
measure: onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
timeFrame: 60-minute beginning at the end of the last injection
measure: onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
timeFrame: Post Anesthesia Care Unit arrival
measure: onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
timeFrame: 15-minute after Post Anesthesia Care Unit arrival
measure: onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
timeFrame: 30-minute after Post Anesthesia Care Unit arrival
measure: onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
timeFrame: Post Anesthesia Care Unit discharge
Secondary outcomes:
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: 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
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: post block
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: Post Anesthesia Care Unit arrival
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: Day 0 evening
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: Day 1 morning
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: Day 1 evening
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: Day 2 morning
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: Day 2 evening
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: Day 3 morning
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: Day 3 evening
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: Day 4
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: Day 5
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: Day 6
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: Day 7
measure: postoperative Numeric Rating Scale (NRS)
timeFrame: Day 30
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
References: