USG Brachial Plexus Block for Upper Extremity Surgery

Ultrasound-guided Brachial Plexus Block With the Single-penetration Multiple-injection-technique for Upper Extremity Surgery

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.

Study Overview

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

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
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Department of Anaesthesiology, Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blockade performance time (seconds)	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

Outcome Measure	Measure Description	Time Frame
Onset time of blockade (minutes)		Time from block completion to complete sensory and motor block is accomplished.
Number of needle passes		Number of times the direction of the needle changes while performing the block
Patient reported pain related to needle passes (Scale 0-2)	0= no pain; middle; sever pain	Pain related to block performance reported by the patient right after block completion
Duration of time of block postoperatively (hours)		Patient reported the time off ending sensory and motory block

Collaborators and Investigators

• Sponsor: Jens Borglum Neimann
• Investigators: Principal Investigator: Mojgan Vazin, MD, Department of Anaesthesiology, Bispebjerg Hospital

Publications and helpful links

General Publications

• Koscielniak-Nielsen ZJ, Frederiksen BS, Rasmussen H, Hesselbjerg L. A comparison of ultrasound-guided supraclavicular and infraclavicular blocks for upper extremity surgery. Acta Anaesthesiol Scand. 2009 May;53(5):620-6. doi: 10.1111/j.1399-6576.2009.01909.x.
• Mariano ER, Sandhu NS, Loland VJ, Bishop ML, Madison SJ, Abrams RA, Meunier MJ, Ferguson EJ, Ilfeld BM. A randomized comparison of infraclavicular and supraclavicular continuous peripheral nerve blocks for postoperative analgesia. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):26-31. doi: 10.1097/AAP.0b013e318203069b.
• Tran DQ, Munoz L, Zaouter C, Russo G, Finlayson RJ. A prospective, randomized comparison between single- and double-injection, ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):420-4. doi: 10.1097/AAP.0b013e3181ae733a.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: June 10, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): July 21, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Wounds and Injuries; Cysts; Connective Tissue Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Mucinoses; Carpal Tunnel Syndrome; Rupture; Ganglion Cysts; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: BBH-PB; H-2-2012-055 (Other Identifier: The national committee on health research ethics)