Magnetic Resonance Imaging of Interscalene Plexus Block

NCT02175069 | Completed Phase 4

• 1 other identifier: MR-ISB-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Interscalene plexus block is a widely used technique to provide anesthesia and analgesia for surgery at the upper extremity (shoulder and upper arm); it is standard-of-care in many institutions worldwide. Local anesthetic is being injected around the nerves supplying the arm (Plexus brachialis) at a specific location in the arm (between the scalenus muscles, thus called "interscalene plexus block"). The optimal volume of injection with regard to efficacy, safety and avoidance of untoward effects has been subject to intense debate for a long time. In spite of evidence that small volumes (between 5 and 7 mls) are effective for adequate postoperative analgesia, larger volumes up to 40 mls are still frequently used in many practices. However, with the use of such large doses, adverse events are known to occur with increased frequency, including paralysis of the diaphragm or spread of local anesthetic to the spinal cord. This study is intended to help evaluate the effects of small or larger injection of local anesthetic around the brachial plexus, and to correlate the distribution with clinical efficacy, block duration, and possible side effects. It is a randomized, controlled, observer-blinded trial; patients undergoing shoulder or upper arm surgery will be randomly allocated to receive either 5mls or 20mls of local anesthetic for their interscalene plexus block. Magnetic resonance imaging will be performed immediately afterwards, followed by a series of neurological exams during the hospital stay. Test of lung function (spirometry) and ultrasound of the diaphragm will be used to evaluate effects of the block on respiratory mechanics.

Conditions

Disorder of Shoulder

Keywords

Shoulder surgery

Outcome Measures

Primary Outcomes (1)

• Spread of local anesthetics to the epidural space

  Spread of local anesthetics to the epidural space, as seen in the magnetic resonance imaging

  10 minutes

Secondary Outcomes (8)

• Contralateral epidural spread

  10 min

• Spread of local anesthetics to the phrenic nerve

  10 minutes

• Bed side spirometry and ultrasound investigation of the diaphragm in the PACU

  24 hours

• Oxygen saturation in the PACU

  2-6 hours

• Self-reported block duration

  24 hours

Study Arms (2)

Interscalene Nerve Block - 5ml

EXPERIMENTAL

ultrasound guided interscalene plexus block (UISB) Ropivacaine 0.75%, 20ml Gadopentetate-Dimeglumine 0.05 mmol Shoulder Surgery

Procedure: Interscalene Nerve Block; Drug: Gadopentetate-Dimeglumine 0.0125 mmol; Drug: Ropivacaine 0.75%, 5ml; Procedure: Shoulder Surgery

Interscalene Nerve Block - 20ml

ACTIVE COMPARATOR

ultrasound guided interscalene plexus block (UISB) Ropivacaine 0.75%, 5ml Gadopentetate-Dimeglumine 0.0125 mmol Shoulder Surgery

Procedure: Interscalene Nerve Block; Drug: Ropivacaine 0.75%, 20ml; Drug: Gadopentetate-Dimeglumine 0.05 mmol; Procedure: Shoulder Surgery

Interventions

Interscalene Nerve Block PROCEDURE

ultrasound guided interscalene plexus block (UISB) immediately before magnetic resonance imaging of the neck.

Interscalene Nerve Block - 20ml; Interscalene Nerve Block - 5ml

Ropivacaine 0.75%, 20ml DRUG

20 ml of ropivacaine 0.75%

Also known as: Naropin

Interscalene Nerve Block - 20ml

Gadopentetate-Dimeglumine 0.0125 mmol DRUG

0.0125 mmol of gadopentetate-dimeglumine

Also known as: Magnevist

Interscalene Nerve Block - 5ml

Gadopentetate-Dimeglumine 0.05 mmol DRUG

0.05 mmol of gadopentetate-dimeglumine

Also known as: Magnevist

Interscalene Nerve Block - 20ml

Ropivacaine 0.75%, 5ml DRUG

5 ml of ropivacaine 0.75%

Also known as: Naropin

Interscalene Nerve Block - 5ml

Shoulder Surgery PROCEDURE

As per individual requirement (patient-dependent)

Interscalene Nerve Block - 20ml; Interscalene Nerve Block - 5ml

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years
• Surgery of the shoulder (shoulder arthroscopy, open shoulder joint surgery, rotator cuff surgery, tendon transfer, shoulder arthroplasty, humerus fracture surgery)
• Patients willing to undergo magnetic resonance imaging prior to surgery
• Informed consent to participate in the study
• American Society of Anesthesiologists physical score I, II or III

You may not qualify if:

• Refusal to participate in the study
• Inability to understand the study protocol due to language barrier
• Serious cardiac or pulmonary disease such as decompensated heart failure, recent myocardial infarction (less than one month in the past), heart block greater than 2nd degree, obstructive sleep apnea and chronic obstructive lung disease greater than 2nd degree
• renal impairment with an calculated glomerular filtration rate below 60ml/min
• Hypersensitivity to ropivacaine or gadolinium or other contraindications against peripheral nerve blocks
• Chronic opioid usage greater than 15 mg oral morphine equivalents daily, the daily use of adjunctive pain medications (gabapentins, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors)
• Schizophrenia or bipolar disorders, uncontrolled anxiety, claustrophobia
• Peripheral neuropathy
• Hepatic or renal impairment
• Ongoing illicit drug or alcohol abuse
• Metal implants or other contraindications for magnetic resonance imaging
• Coagulopathy
• Participation in additional clinical trials within 4 weeks before screening
• Hearing impairment
• Pregnancy

Sponsors & Collaborators

• Paracelsus Medical University: lead

Study Sites (1)

Paracelsus Medical University, Department of Anesthesiology

Salzburg, Salzburg, 5020, Austria

Location

Related Publications (14)

• Fredrickson MJ, Ball CM, Dalgleish AJ. A prospective randomized comparison of ultrasound guidance versus neurostimulation for interscalene catheter placement. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):590-4. doi: 10.1097/aap.0b013e3181ada622.

  PMID: 19916253 BACKGROUND

• Fredrickson MJ, Ball CM, Dalgleish AJ, Stewart AW, Short TG. A prospective randomized comparison of ultrasound and neurostimulation as needle end points for interscalene catheter placement. Anesth Analg. 2009 May;108(5):1695-700. doi: 10.1213/ane.0b013e31819c29b8.

  PMID: 19372356 BACKGROUND

• Gautier P, Vandepitte C, Ramquet C, DeCoopman M, Xu D, Hadzic A. The minimum effective anesthetic volume of 0.75% ropivacaine in ultrasound-guided interscalene brachial plexus block. Anesth Analg. 2011 Oct;113(4):951-5. doi: 10.1213/ANE.0b013e31822b876f. Epub 2011 Aug 4.

  PMID: 21821517 BACKGROUND

• Vandepitte C, Gautier P, Xu D, Salviz EA, Hadzic A. Effective volume of ropivacaine 0.75% through a catheter required for interscalene brachial plexus blockade. Anesthesiology. 2013 Apr;118(4):863-7. doi: 10.1097/ALN.0b013e3182850dc7.

  PMID: 23353796 BACKGROUND

• Cobcroft MD. Letter: Bilateral spread of analgesia with interscalene brachial plexus block. Anaesth Intensive Care. 1976 Feb;4(1):73. No abstract available.

  PMID: 1252000 BACKGROUND

• Dooley J, Fingerman M, Melton S, Klein SM. Contralateral local anesthetic spread from an outpatient interscalene catheter. Can J Anaesth. 2010 Oct;57(10):936-9. doi: 10.1007/s12630-010-9360-y. Epub 2010 Jul 23.

  PMID: 20652841 BACKGROUND

• Fredrickson MJ, Kilfoyle DH. Neurological complication analysis of 1000 ultrasound guided peripheral nerve blocks for elective orthopaedic surgery: a prospective study. Anaesthesia. 2009 Aug;64(8):836-44. doi: 10.1111/j.1365-2044.2009.05938.x.

  PMID: 19604186 BACKGROUND

• Gologorsky E, Leanza RF. Contralateral anesthesia following interscalene block. Anesth Analg. 1992 Aug;75(2):311-2. doi: 10.1213/00000539-199208000-00046. No abstract available.

  PMID: 1632560 BACKGROUND

• Gomez RS, Mendes TC. Epidural anaesthesia as a complication of attempted brachial plexus blockade using the posterior approach. Anaesthesia. 2006 Jun;61(6):591-2. doi: 10.1111/j.1365-2044.2006.04647.x.

  PMID: 16704597 BACKGROUND

• Kumar A, Battit GE, Froese AB, Long MC. Bilateral cervical and thoracic epidural blockade complicating interscalene brachial plexus block: report of two cases. Anesthesiology. 1971 Dec;35(6):650-2. doi: 10.1097/00000542-197112000-00022. No abstract available.

  PMID: 5124750 BACKGROUND

• Lombard TP, Couper JL. Bilateral spread of analgesia following interscalene brachial plexus block. Anesthesiology. 1983 May;58(5):472-3. doi: 10.1097/00000542-198305000-00016. No abstract available.

  PMID: 6838002 BACKGROUND

• Fritsch G, Hudelmaier M, Danninger T, Brummett C, Bock M, McCoy M. Bilateral loss of neural function after interscalene plexus blockade may be caused by epidural spread of local anesthetics: a cadaveric study. Reg Anesth Pain Med. 2013 Jan-Feb;38(1):64-8. doi: 10.1097/AAP.0b013e318277a870.

  PMID: 23222362 BACKGROUND

• Orebaugh SL, McFadden K, Skorupan H, Bigeleisen PE. Subepineurial injection in ultrasound-guided interscalene needle tip placement. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):450-4. doi: 10.1097/AAP.0b013e3181e859f0.

  PMID: 20814286 BACKGROUND

• Stundner O, Meissnitzer M, Brummett CM, Moser S, Forstner R, Kokofer A, Danninger T, Gerner P, Kirchmair L, Fritsch G. Comparison of tissue distribution, phrenic nerve involvement, and epidural spread in standard- vs low-volume ultrasound-guided interscalene plexus block using contrast magnetic resonance imaging: a randomized, controlled trial. Br J Anaesth. 2016 Mar;116(3):405-12. doi: 10.1093/bja/aev550.

  PMID: 26865133 DERIVED

MeSH Terms

Interventions

Ropivacaine; Gadolinium DTPA

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pentetic Acid; Polyamines; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes

Study Officials

• Peter Gerner, MD

  Department of Anesthesiology, Perioperative Medicine and Intensive Care, Paracelsus Medical University, Salzburg, Austria

  STUDY CHAIR

• Gerhard Fritsch, MD

  Department of Anesthesiology, Perioperative Medicine and Intensive Care, Paracelsus Medical University, Salzburg, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prim. Univ.-Prof. Dr. med. univ. Peter Gerner

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: June 26, 2014
• Study Start: December 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 10, 2014

Record last verified: 2014-07

Locations

AU (1)