Disorder of Shoulder Clinical Trial
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
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Paracelsus Medical University, Department of Anesthesiology | Salzburg |
Lead Sponsor | Collaborator |
---|---|
Paracelsus Medical University |
Austria,
Cobcroft MD. Letter: Bilateral spread of analgesia with interscalene brachial plexus block. Anaesth Intensive Care. 1976 Feb;4(1):73. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Gologorsky E, Leanza RF. Contralateral anesthesia following interscalene block. Anesth Analg. 1992 Aug;75(2):311-2. — View Citation
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. — View Citation
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. — View Citation
Lombard TP, Couper JL. Bilateral spread of analgesia following interscalene brachial plexus block. Anesthesiology. 1983 May;58(5):472-3. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Contralateral epidural spread | as seen on MRI | 10 min | Yes |
Secondary | Spread of local anesthetics to the phrenic nerve | as seen on MRI | 10 minutes | Yes |
Secondary | Bed side spirometry and ultrasound investigation of the diaphragm in the PACU | 24 hours | No | |
Secondary | Oxygen saturation in the PACU | 2-6 hours | Yes | |
Secondary | Self-reported block duration | 24 hours | No | |
Secondary | Self reported pain scores for the first 24 postoperative hours | 24 hrs | No | |
Secondary | Time to first analgesic consumption on demand | 24 hours | No | |
Secondary | Total analgesic consumption (ropivacaine PCA). | 24 hours | No |
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