USG Brachial Plexus Block for Upper Extremity Surgery

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993290
• Other study ID #: BBH-PB
• Secondary ID: H-2-2012-055
• Status: Completed
• Phase: N/A
• First received: June 10, 2013
• Last updated: July 20, 2015
• Start date: April 2013
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of anaesthesiology, Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Jens Borglum Neimann

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View 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. — View Citation

Tran DQ, Muñoz 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Onset time of blockade (minutes)		Time from block completion to complete sensory and motor block is accomplished.	No
Secondary	Number of needle passes		Number of times the direction of the needle changes while performing the block	No
Secondary	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	No
Secondary	Duration of time of block postoperatively (hours)		Patient reported the time off ending sensory and motory block	No