Ultrasound Guidance for Interscalene Brachial Plexus Block

This study has been completed.
Sponsor:
Information provided by:
University of Parma
ClinicalTrials.gov Identifier:
NCT00702416
First received: June 19, 2008
Last updated: November 13, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Shoulder
Orthopedic Surgery
Nerve Block
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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound Guidance or Electrical Nerve Stimulation for Interscalene Brachial Plexus Block: a Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Parma:

Primary Outcome Measures:
  • Onset time of brachial plexus anesthesia [ Time Frame: ≤30 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Successful brachial plexus anesthesia [ Time Frame: ≤30 min ] [ Designated as safety issue: No ]
  • Additional analgesic requirements during surgery [ Time Frame: Duration of surgery ] [ Designated as safety issue: No ]
  • Incidence of paresthesiae during the anesthetic procedure [ Time Frame: ≤30 min ] [ Designated as safety issue: Yes ]
  • Incidence of blood aspiration during the anesthetic procedure [ Time Frame: ≤30 min ] [ Designated as safety issue: Yes ]
  • Number of needle redirections for the performance of the block [ Time Frame: ≤30 min ] [ Designated as safety issue: No ]
  • Pain during performance of the block [ Time Frame: ≤30 min ] [ Designated as safety issue: No ]
  • Pain at rest and on movement (visual analog scale) [ Time Frame: q8h until 48 h after surgery ] [ Designated as safety issue: No ]
  • Local anesthetic consumption on patient-controlled pump [ Time Frame: ≤48 h ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
Procedure: Ultrasound-guided continuous interscalene brachial plexus block

With patients in the supine position, a high-frequency (10-12 MHz) ultrasound transducer in a sterile sheath will be applied to explore the interscalene region and locate the brachial plexus. The transducer will be positioned so as to image the C5 and C6 roots in a single view. Visualization of the C7 root in the same scan will be sought, but will not be required.

A 50-mm, 20 G needle will be advanced in-plane from the postero-lateral side of the transducer. Injection of the local anesthetic will be performed in small aliquots while repositioning of the needle in order to optimize spread of the injectate around the nerve roots.

At the end of the injection, a catheter will be threaded through the needle. The catheter will be positioned to lie deep and close to the imaged nerve roots.

Other Names:
  • Peripheral nerve block
  • Ultrasound
  • Regional anesthesia
Drug: Ropivacaine

Block induction [1% (wt/vol) solution]:

20 ml (200 mg)

Postoperative analgesia [0.2% (wt/vol) solution]:

  • Background infusion: 4 ml/h (8 mg/h)
  • Incremental on-demand dose: 2 ml (4 mg)
  • Lockout time: 15 min
Other Names:
  • Naropin
  • Local anesthetic
  • Amide local anesthetic
Drug: Paracetamol
1 g iv q8h
Other Names:
  • Acetaminophen
  • Perfalgan
  • Analgesic
Drug: Morphine
5 mg im prn q1h (in the postoperative period)
Other Names:
  • Opioid
  • Narcotic
  • Analgesic
Drug: Fentanyl
50 µg iv prn (in the intraoperative period)
Other Names:
  • Opioid
  • Narcotic
  • Analgesic
Procedure: General anesthesia

Will be given in case of block failure and/or patient discomfort intractable with fentanyl during the procedure.

The technique will be left at the discretion of the attending anesthesiologist. Monitored anesthesia care will also be acceptable; the block will be considered as failed in that case as well.

Other Name: Monitored anesthesia care
Active Comparator: ENS Group
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
Procedure: Continuous interscalene brachial plexus block using electrical nerve stimulation

With patients in the supine position, the head will be rotated to the contralateral side. The interscalene groove will be palpated.

A 35-mm, 20 G needle will be inserted at the estimated C6 level (cricoid cartilage) with a 30-45° angle to the skin. The needle will be advanced along a line joining the insertion site to the axilla.

An electrical nerve stimulator will be used at an initial intensity of 1.0 mA (frequency: 2 Hz, pulse width: 0.2 ms). A musculocutaneous or axillary-nerve mediated twitch will be sought

Injection of the local anesthetic will start with a visible motor response at a current <0.5 mA. The catheter will be positioned to as to elicit a motor response at ≤0.4 mA.

Other Names:
  • Peripheral nerve block
  • Electrical nerve stimulation
  • Regional anesthesia
Drug: Ropivacaine

Block induction [1% (wt/vol) solution]:

20 ml (200 mg)

Postoperative analgesia [0.2% (wt/vol) solution]:

  • Background infusion: 4 ml/h (8 mg/h)
  • Incremental on-demand dose: 2 ml (4 mg)
  • Lockout time: 15 min
Other Names:
  • Naropin
  • Local anesthetic
  • Amide local anesthetic
Drug: Paracetamol
1 g iv q8h
Other Names:
  • Acetaminophen
  • Perfalgan
  • Analgesic
Drug: Morphine
5 mg im prn q1h (in the postoperative period)
Other Names:
  • Opioid
  • Narcotic
  • Analgesic
Drug: Fentanyl
50 µg iv prn (in the intraoperative period)
Other Names:
  • Opioid
  • Narcotic
  • Analgesic
Procedure: General anesthesia

Will be given in case of block failure and/or patient discomfort intractable with fentanyl during the procedure.

The technique will be left at the discretion of the attending anesthesiologist. Monitored anesthesia care will also be acceptable; the block will be considered as failed in that case as well.

Other Name: Monitored anesthesia care

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702416

Locations
Italy
University Hospital / Azienda Ospedaliero-Universitaria
Parma, PR, Italy, 43100
Sponsors and Collaborators
University of Parma
Investigators
Principal Investigator: Giorgio Danelli, MD UO II Anestesia, Rianimazione e Terapia Antalgica, AOU Parma
  More Information

Publications:
Responsible Party: Guido Fanelli, MD, University of Parma
ClinicalTrials.gov Identifier: NCT00702416     History of Changes
Other Study ID Numbers: ANEST-ORT-01
Study First Received: June 19, 2008
Last Updated: November 13, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by University of Parma:
Analgesia, Patient-controlled
Anesthesia, Regional
Ultrasound
Postoperative Pain
Brachial Plexus

Additional relevant MeSH terms:
Analgesics
Anesthetics
Anesthetics, Local
Narcotics
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014