Onset and Duration of Forearm Nerve Blockade

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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Drug: Lidocaine; Drug: Lidocaine; Drug: Bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, B-3600
      • Ziekenhuis Oost-Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine distal forearm; Lidocaine 1% - Ultrasound-guided specific blocks of the DISTAL median and ulnar nerves with perineural injections of Lidocaine1%. Volume injected is 6 mL/nerve; 12 mL total.	Drug: Lidocaine; lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total; Drug: Lidocaine; lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
Active Comparator: Bupivacaine distal forearm; Bupivacaine 0.5%-Ultrasound-guided specific blocks of the DISTAL median and ulnar nerves with perineural injections of Bupivacaine0.5%. Volume injected is 6 mL/nerve; 12 mL total.	Drug: Bupivacaine; Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
Active Comparator: Lidocaine distal and proximal forearm; Lidocaine 1%- Ultrasound-guided specific blocks of the DISTAL and PROXIMAL median and ulnar nerves with perineural injections of Lidocaine 1%. Volume injected is 3 mL/nerve; 12 mL total	Drug: Lidocaine; lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total; Drug: Lidocaine; lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
Active Comparator: Bupivacaine distal and proximal forearm; Bupivacaine 0.5%- Ultrasound-guided specific blocks of the DISTAL and PROXIMAL median and ulnar nerves with perineural injections of Bupivacaine 0.5 %. Volume injected is 3 mL/nerve; 12 mL total.	Drug: Bupivacaine; Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves	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.	5-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves	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.	10-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves	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.	15-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves	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.	20-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves	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.	25-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves	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.	30-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves	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.	45-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves	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.	60-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves	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.	Post Anesthesia Care Unit arrival
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves	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.	15-minute after Post Anesthesia Care Unit arrival
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves	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.	30-minute after Post Anesthesia Care Unit arrival
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves	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.	Post Anesthesia Care Unit discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative Numeric Rating Scale (NRS)	pain rating(numeric rating scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	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
postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	post block
postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Post Anesthesia Care Unit arrival
postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 0 evening
postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 1 morning
postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 1 evening
postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 2 morning
postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 2 evening
postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 3 morning
postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 3 evening
postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 4
postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 5
postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 6
postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 7
postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 30

Collaborators and Investigators

• Sponsor: New York School of Regional Anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Bupivacaine
• Other Study ID Numbers: 1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No