DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Magnetic Resonance Imaging of Interscalene Plexus Block

Information source: Paracelsus Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Disorder of Shoulder

Intervention: Interscalene Nerve Block (Procedure); Ropivacaine 0.75%, 20ml (Drug); Gadopentetate-Dimeglumine 0.0125 mmol (Drug); Gadopentetate-Dimeglumine 0.05 mmol (Drug); Ropivacaine 0.75%, 5ml (Drug); Shoulder Surgery (Procedure)

Phase: Phase 4

Status: Completed

Sponsored by: Paracelsus Medical University

Official(s) and/or principal investigator(s):
Peter Gerner, MD, Study Chair, Affiliation: Department of Anesthesiology, Perioperative Medicine and Intensive Care, Paracelsus Medical University, Salzburg, Austria
Gerhard Fritsch, MD, Principal Investigator, Affiliation: Department of Anesthesiology, Perioperative Medicine and Intensive Care, Paracelsus Medical University, Salzburg, Austria

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.

Clinical Details

Official title: Magnetic Resonance Imaging of Local Anesthetic Distribution: A Comparison of 5 and 15 Milliliters of Ropivacaine 0,75% for Ultrasound Guided Interscalene Plexus Blockade

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Spread of local anesthetics to the epidural space

Secondary outcome:

Contralateral epidural spread

Spread of local anesthetics to the phrenic nerve

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

Oxygen saturation in the PACU

Self-reported block duration

Self reported pain scores for the first 24 postoperative hours

Time to first analgesic consumption on demand

Total analgesic consumption (ropivacaine PCA).

Detailed description: Background: Interscalene plexus blockade (ISB) is frequently used during surgery of the upper limb. The use of ultrasound has significantly reduced time of onset and total volume of local anesthetics in comparison to nerve localization by stimulators. (1-4) The introduction of this technique has been correlated with decreased volumes of effective local anesthetics from 40 milliliters and more down to 10 milliliters and less.(3-4) As the injection site of ISB is located in close proximity to the anatomical structures of the spinal cord, spread of local anesthetics could potentially cause adverse events, including contralateral blockade and total spinal anesthesia. Case reports on these complications have been published previously. (5-11)In a recently published study we showed that the phenomenon of epidural spread can be reproduced in cadavers and seems to be positively correlated to injection-volumes exceeding 10 milliliters.(12) Moreover, we observed a trend towards cranial spread of the contrast agent in all investigated specimens along the course of the nerval roots towards the spinal cord. In another cadaveric study by Orebauch et al., cranial epidural spread was also detectable following injection of dye into the nerval roots of the brachial plexus.(13) Magnetic resonance imaging has not yet been used for visualization of the spread of local anaesthetics in ISB. Given that ultrasound provides excellent visualization of target-structures in regional anesthesia and therefore enables physicians to place injection needles with enormous accuracy, the question arises whether there is a critical volume for local anesthetics increasing complications such as epidural spread and in consequence contralateral blockade. The aim of this study is to confirm the findings of our cadaveric study in vivo and to show that the frequency of epidural spread correlates with injection of increased volumes of local anesthetics. Primary endpoint: Spread of local anesthetics to the epidural space Secondary endpoints:

- Contralateral epidural spread.

- Spread of local anesthetics to the phrenic nerve.

- Bed side spirometry and ultrasound investigation of the diaphragm in the PACU.

- Oxygen saturation in the PACU

- Self-reported block duration.

- Self reported pain scores for the first 24 postoperative hours

- Time to first analgesic consumption on demand.

- Total analgesic consumption (ropivacaine PCA).

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Locations and Contacts

Paracelsus Medical University, Department of Anesthesiology, Salzburg 5020, Austria
Additional Information

Related publications:

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.

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.

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.

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.

Cobcroft MD. Letter: Bilateral spread of analgesia with interscalene brachial plexus block. Anaesth Intensive Care. 1976 Feb;4(1):73.

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.

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.

Gologorsky E, Leanza RF. Contralateral anesthesia following interscalene block. Anesth Analg. 1992 Aug;75(2):311-2.

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.

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.

Lombard TP, Couper JL. Bilateral spread of analgesia following interscalene brachial plexus block. Anesthesiology. 1983 May;58(5):472-3.

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.

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.

Starting date: December 2013
Last updated: July 9, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017