Clinical trial NCT01993290: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Blockade performance time (seconds)
timeFrame: Time (seconds) from the time the ultrasound transducer is placed on the skin and until the needle is taken out of the body.
Secondary outcomes:
measure: Onset time of blockade (minutes)
timeFrame: Time from block completion to complete sensory and motor block is accomplished.
measure: Number of needle passes
timeFrame: Number of times the direction of the needle changes while performing the block
measure: Patient reported pain related to needle passes (Scale 0-2)
timeFrame: Pain related to block performance reported by the patient right after block completion
measure: Duration of time of block postoperatively (hours)
timeFrame: Patient reported the time off ending sensory and motory block
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of anaesthesiology, Bispebjerg Hospital
Study officials:
affiliation: Department of Anaesthesiology, Bispebjerg hospital
name: Mojgan Vazin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.