ClinicalTrials.gov
ClinicalTrials.gov Menu

USG Brachial Plexus Block for Upper Extremity Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01993290
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Jens Borglum Neimann, Bispebjerg Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
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 Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Brachial Plexus Block With the Single-penetration Multiple-injection-technique for Upper Extremity Surgery
Study Start Date : April 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : June 2015


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Onset time of blockade (minutes) [ Time Frame: Time from block completion to complete sensory and motor block is accomplished. ]
  2. Number of needle passes [ Time Frame: Number of times the direction of the needle changes while performing the block ]
  3. 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 ]

    0= no pain

    1. middle
    2. sever pain

  4. Duration of time of block postoperatively (hours) [ Time Frame: Patient reported the time off ending sensory and motory block ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01993290


Locations
Denmark
Department of anaesthesiology, Bispebjerg Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Jens Borglum Neimann
Investigators
Principal Investigator: Mojgan Vazin, MD Department of Anaesthesiology, Bispebjerg hospital

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 ( Other Identifier: The national committee on health research ethics )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Wounds and Injuries
Cumulative Trauma Disorders
Rupture
Carpal Tunnel Syndrome
Ganglion Cysts
Synovial Cyst
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
Sensory System Agents
Peripheral Nervous System Agents