Ultrasound Guidance or Electrical Nerve Stimulation for Interscalene Brachial Plexus Block: a Randomized, Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Ultrasound-guided continuous interscalene brachial plexus block
- Conditions
- Shoulder
- Sponsor
- University of Parma
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Onset time of brachial plexus anesthesia
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
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
Arms & Interventions
US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
Intervention: Ultrasound-guided continuous interscalene brachial plexus block
US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
Intervention: Ropivacaine
US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
Intervention: Paracetamol
US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
Intervention: Morphine
US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
Intervention: Fentanyl
US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
Intervention: General anesthesia
ENS Group
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
Intervention: Continuous interscalene brachial plexus block using electrical nerve stimulation
ENS Group
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
Intervention: Ropivacaine
ENS Group
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
Intervention: Paracetamol
ENS Group
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
Intervention: Morphine
ENS Group
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
Intervention: Fentanyl
ENS Group
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
Intervention: General anesthesia
Outcomes
Primary Outcomes
Onset time of brachial plexus anesthesia
Time Frame: ≤30 min
Secondary Outcomes
- 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)