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Completed

NCT Number: NCT03649763

Onset and Duration of Forearm Nerve Blockade

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.

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Key information

Conditions

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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, B-3600, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Lidocaine

Drug

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

Bupivacaine

Drug

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

Primary outcomes

  1. onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves

    Time frame: 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.

  2. onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves

    Time frame: 10-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.

  3. onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves

    Time frame: 15-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.

  4. onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves

    Time frame: 20-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.

  5. onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves

    Time frame: 25-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.

  6. onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves

    Time frame: 30-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.

  7. onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves

    Time frame: 45-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.

  8. onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves

    Time frame: 60-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.

  9. onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves

    Time frame: Post Anesthesia Care Unit arrival

    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. onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves

    Time frame: 15-minute after Post Anesthesia Care Unit arrival

    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.

  11. onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves

    Time frame: 30-minute after Post Anesthesia Care Unit arrival

    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.

  12. onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves

    Time frame: Post Anesthesia Care Unit discharge

    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 outcomes

  1. postoperative Numeric Rating Scale (NRS)

    Time frame: 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)

  2. postoperative Numeric Rating Scale (NRS)

    Time frame: post block

    pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)

  3. postoperative Numeric Rating Scale (NRS)

    Time frame: Post Anesthesia Care Unit arrival

    pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)

  4. postoperative Numeric Rating Scale (NRS)

    Time frame: Day 0 evening

    pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)

  5. postoperative Numeric Rating Scale (NRS)

    Time frame: Day 1 morning

    pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)

  6. postoperative Numeric Rating Scale (NRS)

    Time frame: Day 1 evening

    pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)

  7. postoperative Numeric Rating Scale (NRS)

    Time frame: Day 2 morning

    pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)

  8. postoperative Numeric Rating Scale (NRS)

    Time frame: Day 2 evening

    pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)

  9. postoperative Numeric Rating Scale (NRS)

    Time frame: Day 3 morning

    pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)

  10. postoperative Numeric Rating Scale (NRS)

    Time frame: Day 3 evening

    pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)

  11. postoperative Numeric Rating Scale (NRS)

    Time frame: Day 4

    pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)

  12. postoperative Numeric Rating Scale (NRS)

    Time frame: Day 5

    pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)

  13. postoperative Numeric Rating Scale (NRS)

    Time frame: Day 6

    pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)

  14. postoperative Numeric Rating Scale (NRS)

    Time frame: Day 7

    pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)

  15. postoperative Numeric Rating Scale (NRS)

    Time frame: Day 30

    pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)

Sponsors and collaborators

Lead sponsor

New York School of Regional Anesthesia

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 28, 2018
Registry last updated
Feb 26, 2019

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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