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Onset and Duration of Forearm Nerve Blockade

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Lidocaine
Bupivacaine
Lidocaine
Sponsored by
New York School of Regional Anesthesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ziekenhuis Oost-Limburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lidocaine distal forearm

Bupivacaine distal forearm

Lidocaine distal and proximal forearm

Bupivacaine distal and proximal forearm

Arm Description

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.

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.

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
August 1, 2018
Last Updated
February 22, 2019
Sponsor
New York School of Regional Anesthesia
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1. Study Identification

Unique Protocol Identification Number
NCT03649763
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York School of Regional Anesthesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine distal forearm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Bupivacaine distal forearm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lidocaine distal and proximal forearm
Arm Type
Active Comparator
Arm Description
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
Arm Title
Bupivacaine distal and proximal forearm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
Primary Outcome Measure Information:
Title
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Description
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.
Time Frame
5-minute beginning at the end of the last injection
Title
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Description
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.
Time Frame
10-minute beginning at the end of the last injection
Title
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Description
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.
Time Frame
15-minute beginning at the end of the last injection
Title
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Description
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.
Time Frame
20-minute beginning at the end of the last injection
Title
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Description
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.
Time Frame
25-minute beginning at the end of the last injection
Title
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Description
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.
Time Frame
30-minute beginning at the end of the last injection
Title
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Description
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.
Time Frame
45-minute beginning at the end of the last injection
Title
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Description
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.
Time Frame
60-minute beginning at the end of the last injection
Title
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Description
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.
Time Frame
Post Anesthesia Care Unit arrival
Title
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Description
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.
Time Frame
15-minute after Post Anesthesia Care Unit arrival
Title
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Description
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.
Time Frame
30-minute after Post Anesthesia Care Unit arrival
Title
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Description
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.
Time Frame
Post Anesthesia Care Unit discharge
Secondary Outcome Measure Information:
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating(numeric rating scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
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
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Time Frame
post block
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Time Frame
Post Anesthesia Care Unit arrival
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Time Frame
Day 0 evening
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Time Frame
Day 1 morning
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Time Frame
Day 1 evening
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Time Frame
Day 2 morning
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Time Frame
Day 2 evening
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Time Frame
Day 3 morning
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Time Frame
Day 3 evening
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Time Frame
Day 4
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Time Frame
Day 5
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Time Frame
Day 6
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Time Frame
Day 7
Title
postoperative Numeric Rating Scale (NRS)
Description
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
B-3600
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Onset and Duration of Forearm Nerve Blockade

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