Onset and Duration of Forearm Nerve Blockade

Carpal Tunnel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03649763
• Other study ID #: 1801
• Status: Completed
• Phase: Phase 4
• Start date: March 7, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: New York School of Regional Anesthesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Drug:
• Lidocaine
lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
• Bupivacaine
Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
• Lidocaine
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
New York School of Regional Anesthesia

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	post block
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 4
Secondary	postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 5
Secondary	postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 6
Secondary	postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 7
Secondary	postoperative Numeric Rating Scale (NRS)	pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)	Day 30