Clinical trial NCT00702416: Ultrasound Guidance for Interscalene Brachial Plexus Block
Official title: Ultrasound Guidance or Electrical Nerve Stimulation for Interscalene Brachial Plexus Block: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Shoulder
Orthopedic Surgery
Nerve Block
Keywords: Analgesia, Patient-controlled
Anesthesia, Regional
Ultrasound
Postoperative Pain
Brachial Plexus
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2008-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study has been designed to assess the possible advantages of using ultrasound imaging to block the brachial plexus (i.e., nerves of the upper limb) in patients undergoing shoulder surgery.

The ultrasound technique will be compared with the current gold standard, electrical nerve stimulation.

The aim of this study is to define which technique is better in terms of time to onset of anesthesia.

Detailed description: The study will compare real-time ultrasound (US) guidance and electrical nerve stimulation (ENS) in terms of onset time for interscalene brachial plexus anesthesia.

The main hypothesis is that direct visualization of neural structures under US guidance will grant better local anesthetic (LA) disposition around the roots of the plexus, thus improving onset times.

Perineural catheters will be used to maintain regional analgesia for 48 hours after surgery. We hypothesize that US guidance may also help physicians place perineural catheters more precisely, thus improving analgesia in the following hours to days.

Finally, we will investigate for possible differences in minor adverse events such as vascular puncture, pain during the anesthetic procedure.

Eligibility criteria: Inclusion Criteria:

* ASA Physical Status Class I-III
* Elective surgery of the shoulder
* Informed consent to regional anesthesia

Exclusion Criteria:

* Inability to effectively communicate
* Chronic opioid use
* Absence of informed consent to participation to the study
* Ipsilateral upper limb neurological deficits
* Known allergy to study medications
* Contraindications to continuous block placement

Primary outcomes:
measure: Onset time of brachial plexus anesthesia
timeFrame: ≤30 min
Secondary outcomes:
measure: Successful brachial plexus anesthesia
timeFrame: ≤30 min
measure: Additional analgesic requirements during surgery
timeFrame: Duration of surgery
measure: Incidence of paresthesiae during the anesthetic procedure
timeFrame: ≤30 min
measure: Incidence of blood aspiration during the anesthetic procedure
timeFrame: ≤30 min
measure: Number of needle redirections for the performance of the block
timeFrame: ≤30 min
measure: Pain during performance of the block
timeFrame: ≤30 min
measure: Pain at rest and on movement (visual analog scale)
timeFrame: q8h until 48 h after surgery
measure: Local anesthetic consumption on patient-controlled pump
timeFrame: ≤48 h
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University Hospital / Azienda Ospedaliero-Universitaria
state: PR
Study officials:
affiliation: UO II Anestesia, Rianimazione e Terapia Antalgica, AOU Parma
name: Giorgio Danelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Casati A, Fanelli G, Aldegheri G, Berti M, Colnaghi E, Cedrati V, Torri G. Interscalene brachial plexus anaesthesia with 0.5%, 0.75% or 1% ropivacaine: a double-blind comparison with 2% mepivacaine. Br J Anaesth. 1999 Dec;83(6):872-5. doi: 10.1093/bja/83.6.872.
citation: Stevens MF, Werdehausen R, Golla E, Braun S, Hermanns H, Ilg A, Willers R, Lipfert P. Does interscalene catheter placement with stimulating catheters improve postoperative pain or functional outcome after shoulder surgery? A prospective, randomized and double-blinded trial. Anesth Analg. 2007 Feb;104(2):442-7. doi: 10.1213/01.ane.0000253513.15336.25.
citation: Casati A, Borghi B, Fanelli G, Montone N, Rotini R, Fraschini G, Vinciguerra F, Torri G, Chelly J. Interscalene brachial plexus anesthesia and analgesia for open shoulder surgery: a randomized, double-blinded comparison between levobupivacaine and ropivacaine. Anesth Analg. 2003 Jan;96(1):253-9, table of contents. doi: 10.1097/00000539-200301000-00051.
citation: Casati A, Danelli G, Baciarello M, Corradi M, Leone S, Di Cianni S, Fanelli G. A prospective, randomized comparison between ultrasound and nerve stimulation guidance for multiple injection axillary brachial plexus block. Anesthesiology. 2007 May;106(5):992-6. doi: 10.1097/01.anes.0000265159.55179.e1.