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Onset and Duration of Forearm Nerve Blockade

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ClinicalTrials.gov Identifier: NCT03649763
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Catherine Vandepitte, M.D., New York School of Regional Anesthesia

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: Lidocaine Drug: Bupivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 7, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018


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

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 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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649763


Locations
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Belgium
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, B-3600
Sponsors and Collaborators
New York School of Regional Anesthesia

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Responsible Party: Catherine Vandepitte, M.D., Medical Doctor, New York School of Regional Anesthesia
ClinicalTrials.gov Identifier: NCT03649763     History of Changes
Other Study ID Numbers: 1801
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action