Ultrasound Guidance for Interscalene Brachial Plexus Block

Phase 4

Completed

• Conditions: Shoulder; Orthopedic Surgery; Nerve Block
• Interventions: Procedure: Ultrasound-guided continuous interscalene brachial plexus block; Procedure: Continuous interscalene brachial plexus block using electrical nerve stimulation; Drug: Ropivacaine; Drug: Paracetamol; Drug: Morphine; Drug: Fentanyl; Procedure: General anesthesia

• Registration Number: NCT00702416
• Lead Sponsor: University of Parma

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-20
• Status Verified: 2009-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2009-11-13
• Last Update Posted: 2009-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US Group	Ultrasound-guided continuous interscalene brachial plexus block	In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
US Group	Morphine	In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
US Group	General anesthesia	In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
ENS Group	Continuous interscalene brachial plexus block using electrical nerve stimulation	In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
ENS Group	General anesthesia	In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
US Group	Ropivacaine	In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
US Group	Paracetamol	In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
US Group	Fentanyl	In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
ENS Group	Ropivacaine	In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
ENS Group	Paracetamol	In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
ENS Group	Morphine	In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
ENS Group	Fentanyl	In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.

Primary Outcome Measures

Name	Time	Method
Onset time of brachial plexus anesthesia	≤30 min

Secondary Outcome Measures

Name	Time	Method
Successful brachial plexus anesthesia	≤30 min
Additional analgesic requirements during surgery	Duration of surgery
Incidence of paresthesiae during the anesthetic procedure	≤30 min
Incidence of blood aspiration during the anesthetic procedure	≤30 min
Number of needle redirections for the performance of the block	≤30 min
Pain during performance of the block	≤30 min
Pain at rest and on movement (visual analog scale)	q8h until 48 h after surgery
Local anesthetic consumption on patient-controlled pump	≤48 h

Trial Locations

Locations (1)

University Hospital / Azienda Ospedaliero-Universitaria; 🇮🇹 Parma, PR, Italy