Back to results

USG Brachial Plexus Block for Upper Extremity Surgery

Primary Purpose

Fracture at Wrist and/or Hand Level, Rupture of Tendon of Wrist and Hand, Injuries to the Wrist, Hand and Fingers (S60-S69)

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Ropivacaine

About this trial

This is an interventional treatment trial for Fracture at Wrist and/or Hand Level

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of anaesthesiology, Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

USG Supraclavicular block

Lateral infraclavicular block

USG Axillaris block

Arm Description

20 ml of ropivacaine 0,75% is administered to brachial plexus at supraclavicular level.

20 ml of ropivacaine 0,75 % is administered to brachialis plexus at lateral infraclavicular level

20 ml of ropivacaine 0,75% is administered to plexus brachialis at axillaris level

Outcomes

Primary Outcome Measures

Blockade performance time (seconds)

Secondary Outcome Measures

Onset time of blockade (minutes)

Number of needle passes

Patient reported pain related to needle passes (Scale 0-2)

0= no pain middle sever pain

Duration of time of block postoperatively (hours)

Full Information

NCT ID

NCT01993290

First Posted

June 10, 2013

Last Updated

July 20, 2015

Sponsor

Jens Borglum Neimann

1. Study Identification

Unique Protocol Identification Number

NCT01993290

Brief Title

USG Brachial Plexus Block for Upper Extremity Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jens Borglum Neimann

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

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

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

USG Supraclavicular block

Arm Type

Active Comparator

Arm Description

20 ml of ropivacaine 0,75% is administered to brachial plexus at supraclavicular level.

Arm Title

Lateral infraclavicular block

Arm Type

Active Comparator

Arm Description

20 ml of ropivacaine 0,75 % is administered to brachialis plexus at lateral infraclavicular level

Arm Title

USG Axillaris block

Arm Type

Active Comparator

Arm Description

20 ml of ropivacaine 0,75% is administered to plexus brachialis at axillaris level

Intervention Type

Drug

Intervention Name(s)

Ropivacaine

Other Intervention Name(s)

Naropin

Intervention Description

20 ml in total of 0,75% Ropivacaine is administered to each patient in all three arms.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Onset time of blockade (minutes)

Time Frame

Time from block completion to complete sensory and motor block is accomplished.

Title

Number of needle passes

Time Frame

Number of times the direction of the needle changes while performing the block

Title

Patient reported pain related to needle passes (Scale 0-2)

Description

0= no pain middle sever pain

Time Frame

Pain related to block performance reported by the patient right after block completion

Title

Duration of time of block postoperatively (hours)

Time Frame

Patient reported the time off ending sensory and motory block

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mojgan Vazin, MD

Organizational Affiliation

Department of Anaesthesiology, Bispebjerg hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of anaesthesiology, Bispebjerg Hospital

City

Copenhagen

ZIP/Postal Code

2400

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

19419356

Citation

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.

Results Reference

background

PubMed Identifier

21455085

Citation

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.

Results Reference

background

PubMed Identifier

19920418

Citation

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.

Results Reference

background

Learn more about this trial

USG Brachial Plexus Block for Upper Extremity Surgery

We'll reach out to this number within 24 hrs