Onset and Duration of Forearm Nerve Blockade

NCT03649763 | Completed Phase 4

• 1 other identifier: 1801
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (15)

• 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

• postoperative Numeric Rating Scale (NRS)

  post block

• postoperative Numeric Rating Scale (NRS)

  Post Anesthesia Care Unit arrival

• postoperative Numeric Rating Scale (NRS)

  Day 0 evening

• postoperative Numeric Rating Scale (NRS)

  Day 1 morning

Study Arms (4)

Lidocaine distal forearm

ACTIVE COMPARATOR

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

Bupivacaine distal forearm

ACTIVE COMPARATOR

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

Lidocaine distal and proximal forearm

ACTIVE COMPARATOR

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

Bupivacaine distal and proximal forearm

ACTIVE COMPARATOR

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

Interventions

Lidocaine DRUG

lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total

Lidocaine distal forearm

Bupivacaine DRUG

Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total

Bupivacaine distal and proximal forearm; Bupivacaine distal forearm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York School of Regional Anesthesia: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, B-3600, Belgium

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Lidocaine; Bupivacaine

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 28, 2018
• Study Start: March 7, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

BE (1)