USG Brachial Plexus Block for Upper Extremity Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Bispebjerg Hospital
Sponsor:
Information provided by (Responsible Party):
Jens Borglum Neimann, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01993290
First received: June 10, 2013
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

Ultrasound-guided (USG) brachial plexus (BP) block efficacy at the Supraclavicular (SCL), Lateral- Infraclavicular (LIC) and Axillary (AX) level: Randomized, observer-blinded study of the single-penetration multiple-injection-technique.


Condition Intervention
Fracture at Wrist and/or Hand Level
Rupture of Tendon of Wrist and Hand
Injuries to the Wrist, Hand and Fingers (S60-S69)
Ganglion Cysts
Carpal Tunnel Syndrome
Drug: Ropivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Brachial Plexus Block With the Single-penetration Multiple-injection-technique for Upper Extremity Surgery

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Blockade performance time (seconds) [ Time Frame: Time (seconds) from the time the ultrasound transducer is placed on the skin and until the needle is taken out of the body. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Onset time of blockade (minutes) [ Time Frame: Time from block completion to complete sensory and motor block is accomplished. ] [ Designated as safety issue: No ]
  • Number of needle passes [ Time Frame: Number of times the direction of the needle changes while performing the block ] [ Designated as safety issue: No ]
  • Patient reported pain related to needle passes (Scale 0-2) [ Time Frame: Pain related to block performance reported by the patient right after block completion ] [ Designated as safety issue: No ]

    0= no pain

    1. middle
    2. sever pain

  • Duration of time of block postoperatively (hours) [ Time Frame: Patient reported the time off ending sensory and motory block ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: USG Supraclavicular block
20 ml of ropivacaine 0,75% is administered to brachial plexus at supraclavicular level.
Drug: Ropivacaine
20 ml in total of 0,75% Ropivacaine is administered to each patient in all three arms.
Other Name: Naropin
Active Comparator: Lateral infraclavicular block
20 ml of ropivacaine 0,75 % is administered to brachialis plexus at lateral infraclavicular level
Drug: Ropivacaine
20 ml in total of 0,75% Ropivacaine is administered to each patient in all three arms.
Other Name: Naropin
Active Comparator: USG Axillaris block
20 ml of ropivacaine 0,75% is administered to plexus brachialis at axillaris level
Drug: Ropivacaine
20 ml in total of 0,75% Ropivacaine is administered to each patient in all three arms.
Other Name: Naropin

Detailed Description:

The investigators will compare the BP block efficacy (for surgical anaesthesia) with the USG single-penetration multiple-injection-technique at the SCL, LIC and AX level for upper-extremity surgery (elbow, forearm, wrist, hand). The investigators want to investigate whether the single-penetration multiple-injection-technique would provide for safe surgical anaesthesia with lower volumes of local anaesthetics than has previously been described in a comparative study at the three different levels.

120 patients will prospectively be randomized to an USG BP block administered as a single-penetration multiple-injection-technique at one of three different levels: (1) SCL (2) LIC (3) AX. Ropivacaine 0.75% (20 mL) will be used for all blocks prior to surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age above 18 years
  • American Society of Anaesthesiology class 1-3
  • Patients undergoing upper extremity surgery

Exclusion Criteria:

  • Inability to cooperate
  • Inability to understand and talk danish
  • Allergic to ropivacaine
  • Infection at site of surgery
  • Neurological dysfunction at site of surgery
  • Severe coagulopathy
  • Drug and alcohol abuse
  • Patients, who can not get a nerve block due to technical difficulty
  • Pregnancy or nursing
  • Body mass index >35
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01993290

Contacts
Contact: Mojgan Vazin, MD 23229571 ext 0045 mojganvazin@hotmail.com
Contact: Jens Borglum, MD, ph.d 40260554 ext 0045 jens.borglum@gmail.com

Locations
Denmark
Department of anaesthesiology, Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Principal Investigator: Mojgan Vazin, MD         
Sub-Investigator: Jens Borglum, MD, ph.d         
Sponsors and Collaborators
Jens Borglum Neimann
Investigators
Principal Investigator: Mojgan Vazin, MD Department of Anaesthesiology, Bispebjerg hospital
  More Information

Publications:
Responsible Party: Jens Borglum Neimann, Associate professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01993290     History of Changes
Other Study ID Numbers: BBH-PB, H-2-2012-055
Study First Received: June 10, 2013
Last Updated: November 20, 2013
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Wounds and Injuries
Cumulative Trauma Disorders
Carpal Tunnel Syndrome
Synovial Cyst
Ganglion Cysts
Rupture
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Sprains and Strains
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014