Disorder of ShoulderPhase 4NCT02175069
Magnetic Resonance Imaging of Interscalene Plexus Block
A Phase 4 study testing Interscalene Nerve Block, Ropivacaine 0.75%, 20ml and Gadopentetate-Dimeglumine 0.0125 mmol in people with Disorder of Shoulder, run by Paracelsus Medical University at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Disorder of Shoulder
- What is being tested?
- Interscalene Nerve Block, Ropivacaine 0.75%, 20ml and Gadopentetate-Dimeglumine 0.0125 mmol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2013to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Paracelsus Medical University, Department of Anesthesiology
Salzburg, State of Salzburg, 5020
About this study
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.
Read the 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).
- Conditions
- Disorder of Shoulder
- Being tested
- Interscalene Nerve Block, Ropivacaine 0.75%, 20ml, Gadopentetate-Dimeglumine 0.0125 mmol, Gadopentetate-Dimeglumine 0.05 mmol, Ropivacaine 0.75%, 5ml
- Keywords
- Shoulder surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene Nerve BlockProcedure or surgery
ultrasound guided interscalene plexus block (UISB) immediately before magnetic resonance imaging of the neck.
Ropivacaine 0.75%, 20mlDrug
Also called Naropin
20 ml of ropivacaine 0.75%
Gadopentetate-Dimeglumine 0.0125 mmolDrug
Also called Magnevist
0.0125 mmol of gadopentetate-dimeglumine
Gadopentetate-Dimeglumine 0.05 mmolDrug
Also called Magnevist
0.05 mmol of gadopentetate-dimeglumine
Ropivacaine 0.75%, 5mlDrug
Also called Naropin
5 ml of ropivacaine 0.75%
Shoulder SurgeryProcedure or surgery
As per individual requirement (patient-dependent)
| Study group | Role | What they receive |
|---|---|---|
| Interscalene Nerve Block - 5ml | Experimental | ultrasound guided interscalene plexus block (UISB)
Ropivacaine 0.75%, 20ml Gadopentetate-Dimeglumine 0.05 mmol Shoulder Surgery Receives: 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 Receives: Procedure: Interscalene Nerve Block; Drug: Ropivacaine 0.75%, 20ml; Drug: Gadopentetate-Dimeglumine 0.05 mmol; Procedure: Shoulder Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spread of local anesthetics to the epidural space
Spread of local anesthetics to the epidural space, as seen in the magnetic resonance imaging
Measured: 10 minutes
Secondary outcomes (8)
Contralateral epidural spread
as seen on MRI
Measured: 10 min
Spread of local anesthetics to the phrenic nerve
as seen on MRI
Measured: 10 minutes
Bed side spirometry and ultrasound investigation of the diaphragm in the PACU
Measured: 24 hours
Oxygen saturation in the PACU
Measured: 2-6 hours
Self-reported block duration
Measured: 24 hours
Self reported pain scores for the first 24 postoperative hours
Measured: 24 hrs
Time to first analgesic consumption on demand
Measured: 24 hours
Total analgesic consumption (ropivacaine PCA).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Disorder of ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Peter Gerner, M.D., Paracelsus Medical University
- Investigators
- Peter Gerner, MD, Study chair, Department of Anesthesiology, Perioperative Medicine and Intensive Care, Paracelsus Medical University, Salzburg, AustriaGerhard Fritsch, MD, Principal investigator, Department of Anesthesiology, Perioperative Medicine and Intensive Care, Paracelsus Medical University, Salzburg, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175069
- Sponsor's protocol ID
- MR-ISB-1
- Status last verified
- Jul 2014
- First submitted
- 17 Apr 2014
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1097/aap.0b013e3181ada622.
PubMed 19916253Fredrickson 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.
PubMed 19372356Gautier 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.
PubMed 21821517Vandepitte 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.
PubMed 23353796Cobcroft MD. Letter: Bilateral spread of analgesia with interscalene brachial plexus block. Anaesth Intensive Care. 1976 Feb;4(1):73. No abstract available.
PubMed 1252000Dooley 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.
PubMed 20652841Fredrickson 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.
PubMed 19604186Gologorsky 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.
PubMed 1632560Gomez 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.
PubMed 16704597Kumar 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.
PubMed 5124750Lombard 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.
PubMed 6838002Fritsch 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.
PubMed 23222362Orebaugh 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.
PubMed 20814286Stundner 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.
PubMed 26865133
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02175069
- Acronym / sponsor ID
- MR-ISB-1
- Conditions
- Disorder of Shoulder
- Keywords
- Shoulder surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene Nerve Block - 5ml | Experimental | Procedure: Interscalene Nerve Block, Drug: Gadopentetate-Dimeglumine 0.0125 mmol, Drug: Ropivacaine 0.75%, 5ml, Procedure: Shoulder Surgeryultrasound guided interscalene plexus block (UISB) Ropivacaine 0.75%, 20ml Gadopentetate-Dimeglumine 0.05 mmol Shoulder Surgery |
| Interscalene Nerve Block - 20ml | Active comparator | Procedure: Interscalene Nerve Block, Drug: Ropivacaine 0.75%, 20ml, Drug: Gadopentetate-Dimeglumine 0.05 mmol, Procedure: Shoulder Surgeryultrasound guided interscalene plexus block (UISB) Ropivacaine 0.75%, 5ml Gadopentetate-Dimeglumine 0.0125 mmol Shoulder Surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interscalene Nerve Blockultrasound guided interscalene plexus block (UISB) immediately before magnetic resonance imaging of the neck. | Procedure or surgery | Interscalene Nerve Block - 20ml, Interscalene Nerve Block - 5ml |
| Ropivacaine 0.75%, 20mlAlso: Naropin20 ml of ropivacaine 0.75% | Drug | Interscalene Nerve Block - 20ml |
| Gadopentetate-Dimeglumine 0.0125 mmolAlso: Magnevist0.0125 mmol of gadopentetate-dimeglumine | Drug | Interscalene Nerve Block - 5ml |
| Gadopentetate-Dimeglumine 0.05 mmolAlso: Magnevist0.05 mmol of gadopentetate-dimeglumine | Drug | Interscalene Nerve Block - 20ml |
| Ropivacaine 0.75%, 5mlAlso: Naropin5 ml of ropivacaine 0.75% | Drug | Interscalene Nerve Block - 5ml |
| Shoulder SurgeryAs per individual requirement (patient-dependent) | Procedure or surgery | Interscalene Nerve Block - 20ml, Interscalene Nerve Block - 5ml |
Primary outcome
Spread of local anesthetics to the epidural space
Time frame: 10 minutes
Spread of local anesthetics to the epidural space, as seen in the magnetic resonance imaging
8 secondary outcomes
Contralateral epidural spread
Time frame: 10 min
Spread of local anesthetics to the phrenic nerve
Time frame: 10 minutes
Bed side spirometry and ultrasound investigation of the diaphragm in the PACU
Time frame: 24 hours
Oxygen saturation in the PACU
Time frame: 2-6 hours
Self-reported block duration
Time frame: 24 hours
Self reported pain scores for the first 24 postoperative hours
Time frame: 24 hrs
Time to first analgesic consumption on demand
Time frame: 24 hours
Total analgesic consumption (ropivacaine PCA).
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
- Background: PubMed 19916253Fredrickson 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.
- Background: PubMed 19372356Fredrickson 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.
- Background: PubMed 21821517Gautier 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.
- Background: PubMed 23353796Vandepitte 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.
- Background: PubMed 1252000Cobcroft MD. Letter: Bilateral spread of analgesia with interscalene brachial plexus block. Anaesth Intensive Care. 1976 Feb;4(1):73. No abstract available.
- Background: PubMed 20652841Dooley 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.
- Background: PubMed 19604186Fredrickson 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.
- Background: PubMed 1632560Gologorsky 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.
- Background: PubMed 16704597Gomez 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.
- Background: PubMed 5124750Kumar 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.
- Background: PubMed 6838002Lombard 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.
- Background: PubMed 23222362Fritsch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Gerner, MD study chair
Department of Anesthesiology, Perioperative Medicine and Intensive Care, Paracelsus Medical University, Salzburg, Austria
Gerhard Fritsch, MD principal investigator
Department of Anesthesiology, Perioperative Medicine and Intensive Care, Paracelsus Medical University, Salzburg, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Interscalene Nerve Block, Ropivacaine 0.75%, 20ml and Gadopentetate-Dimeglumine 0.0125 mmol in people with Disorder of Shoulder, run by Paracelsus Medical University at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spread of local anesthetics to the epidural space (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02175069, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014.