ShoulderPhase 4NCT00702416
Ultrasound Guidance for Interscalene Brachial Plexus Block
A Phase 4 study testing Ultrasound-guided continuous interscalene brachial plexus block, Continuous interscalene brachial plexus block using electrical nerve stimulation and Ropivacaine in people with Shoulder and Orthopedic Surgery, run by University of Parma at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Shoulder, Orthopedic Surgery, Nerve Block
- What is being tested?
- Ultrasound-guided continuous interscalene brachial plexus block, Continuous interscalene brachial plexus block using electrical nerve stimulation and Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- May 2008to Nov 2009
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Physical Status Class I-III
- Elective surgery of the shoulder
- Informed consent to regional anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
University Hospital / Azienda Ospedaliero-Universitaria
Parma, PR, 43100
About this study
Official title: Ultrasound Guidance or Electrical Nerve Stimulation for Interscalene Brachial Plexus Block: a Randomized, Controlled Trial
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.
Read the 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.
- Conditions
- Shoulder, Orthopedic Surgery, Nerve Block
- Being tested
- Ultrasound-guided continuous interscalene brachial plexus block, Continuous interscalene brachial plexus block using electrical nerve stimulation, Ropivacaine, Paracetamol, Morphine
- Keywords
- Analgesia, Patient-controlled, Anesthesia, Regional, Ultrasound, Postoperative Pain, Brachial Plexus
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided continuous interscalene brachial plexus blockProcedure or surgery
Also called Peripheral nerve block, Ultrasound, Regional anesthesia
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.
Continuous interscalene brachial plexus block using electrical nerve stimulationProcedure or surgery
Also called Peripheral nerve block, Electrical nerve stimulation, Regional anesthesia
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.
RopivacaineDrug
Also called Naropin, Local anesthetic, Amide local anesthetic
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
ParacetamolDrug
Also called Acetaminophen, Perfalgan, Analgesic
1 g iv q8h
MorphineDrug
Also called Opioid, Narcotic, Analgesic
5 mg im prn q1h (in the postoperative period)
FentanylDrug
Also called Opioid, Narcotic, Analgesic
50 µg iv prn (in the intraoperative period)
General anesthesiaProcedure or surgery
Also called Monitored anesthesia care
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.
| Study group | Role | What they receive |
|---|---|---|
| US Group | Experimental | In this group, the continuous block will be performed under real-time ultrasound (US) guidance. Receives: Procedure: Ultrasound-guided continuous interscalene brachial plexus block; Drug: Ropivacaine; Drug: Paracetamol; Drug: Morphine; Drug: Fentanyl; Procedure: General anesthesia |
| ENS Group | Active comparator | In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique. Receives: Procedure: Continuous interscalene brachial plexus block using electrical nerve stimulation; Drug: Ropivacaine; Drug: Paracetamol; Drug: Morphine; Drug: Fentanyl; Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time of brachial plexus anesthesia
Measured: ≤30 min
Secondary outcomes (8)
Successful brachial plexus anesthesia
Measured: ≤30 min
Additional analgesic requirements during surgery
Measured: Duration of surgery
Incidence of paresthesiae during the anesthetic procedure
Measured: ≤30 min
Incidence of blood aspiration during the anesthetic procedure
Measured: ≤30 min
Number of needle redirections for the performance of the block
Measured: ≤30 min
Pain during performance of the block
Measured: ≤30 min
Pain at rest and on movement (visual analog scale)
Measured: q8h until 48 h after surgery
Local anesthetic consumption on patient-controlled pump
Measured: ≤48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Investigators
- Giorgio Danelli, MD, Principal investigator, UO II Anestesia, Rianimazione e Terapia Antalgica, AOU Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702416
- Sponsor's protocol ID
- ANEST-ORT-01
- Status last verified
- Nov 2009
- First submitted
- 19 Jun 2008
- Last updated
- 16 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Casati A, Fanelli G, Aldegheri G, Berti M, Colnaghi E, Cedrati V, Torri G. Interscalene brachial plexus anaesthesia with 0.5%, 0.75% or 1% ropivacaine: a double-blind comparison with 2% mepivacaine. Br J Anaesth. 1999 Dec;83(6):872-5. doi: 10.1093/bja/83.6.872.
PubMed 10700785Stevens MF, Werdehausen R, Golla E, Braun S, Hermanns H, Ilg A, Willers R, Lipfert P. Does interscalene catheter placement with stimulating catheters improve postoperative pain or functional outcome after shoulder surgery? A prospective, randomized and double-blinded trial. Anesth Analg. 2007 Feb;104(2):442-7. doi: 10.1213/01.ane.0000253513.15336.25.
PubMed 17242107Casati A, Borghi B, Fanelli G, Montone N, Rotini R, Fraschini G, Vinciguerra F, Torri G, Chelly J. Interscalene brachial plexus anesthesia and analgesia for open shoulder surgery: a randomized, double-blinded comparison between levobupivacaine and ropivacaine. Anesth Analg. 2003 Jan;96(1):253-9, table of contents. doi: 10.1097/00000539-200301000-00051.
PubMed 12505962Casati A, Danelli G, Baciarello M, Corradi M, Leone S, Di Cianni S, Fanelli G. A prospective, randomized comparison between ultrasound and nerve stimulation guidance for multiple injection axillary brachial plexus block. Anesthesiology. 2007 May;106(5):992-6. doi: 10.1097/01.anes.0000265159.55179.e1.
PubMed 17457131
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guidance or Electrical Nerve Stimulation for Interscalene Brachial Plexus Block: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00702416
- Acronym / sponsor ID
- ANEST-ORT-01
- Conditions
- Shoulder, Orthopedic Surgery, Nerve Block
- Keywords
- Analgesia, Patient-controlled, Anesthesia, Regional, Ultrasound, Postoperative Pain, Brachial Plexus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Jun 2008 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US Group | Experimental | Procedure: Ultrasound-guided continuous interscalene brachial plexus block, Drug: Ropivacaine, Drug: Paracetamol, Drug: Morphine, Drug: Fentanyl, Procedure: General anesthesiaIn this group, the continuous block will be performed under real-time ultrasound (US) guidance. |
| ENS Group | Active comparator | Procedure: Continuous interscalene brachial plexus block using electrical nerve stimulation, Drug: Ropivacaine, Drug: Paracetamol, Drug: Morphine, Drug: Fentanyl, Procedure: General anesthesiaIn this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA Physical Status Class I-III
- Elective surgery of the shoulder
- Informed consent to regional anesthesia
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Ultrasound-guided continuous interscalene brachial plexus blockAlso: Peripheral nerve block, Ultrasound, Regional anesthesiaWith 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. | Procedure or surgery | US Group |
| Continuous interscalene brachial plexus block using electrical nerve stimulationAlso: Peripheral nerve block, Electrical nerve stimulation, Regional anesthesiaWith 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. | Procedure or surgery | ENS Group |
| RopivacaineAlso: Naropin, Local anesthetic, Amide local anestheticBlock 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 | Drug | ENS Group, US Group |
| ParacetamolAlso: Acetaminophen, Perfalgan, Analgesic1 g iv q8h | Drug | ENS Group, US Group |
| MorphineAlso: Opioid, Narcotic, Analgesic5 mg im prn q1h (in the postoperative period) | Drug | ENS Group, US Group |
| FentanylAlso: Opioid, Narcotic, Analgesic50 µg iv prn (in the intraoperative period) | Drug | ENS Group, US Group |
| General anesthesiaAlso: Monitored anesthesia careWill 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. | Procedure or surgery | ENS Group, US Group |
Primary outcome
Onset time of brachial plexus anesthesia
Time frame: ≤30 min
8 secondary outcomes
Successful brachial plexus anesthesia
Time frame: ≤30 min
Additional analgesic requirements during surgery
Time frame: Duration of surgery
Incidence of paresthesiae during the anesthetic procedure
Time frame: ≤30 min
Incidence of blood aspiration during the anesthetic procedure
Time frame: ≤30 min
Number of needle redirections for the performance of the block
Time frame: ≤30 min
Pain during performance of the block
Time frame: ≤30 min
Pain at rest and on movement (visual analog scale)
Time frame: q8h until 48 h after surgery
Local anesthetic consumption on patient-controlled pump
Time frame: ≤48 h
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 16 Nov 2009.
- Background: PubMed 10700785Casati A, Fanelli G, Aldegheri G, Berti M, Colnaghi E, Cedrati V, Torri G. Interscalene brachial plexus anaesthesia with 0.5%, 0.75% or 1% ropivacaine: a double-blind comparison with 2% mepivacaine. Br J Anaesth. 1999 Dec;83(6):872-5. doi: 10.1093/bja/83.6.872.
- Background: PubMed 17242107Stevens MF, Werdehausen R, Golla E, Braun S, Hermanns H, Ilg A, Willers R, Lipfert P. Does interscalene catheter placement with stimulating catheters improve postoperative pain or functional outcome after shoulder surgery? A prospective, randomized and double-blinded trial. Anesth Analg. 2007 Feb;104(2):442-7. doi: 10.1213/01.ane.0000253513.15336.25.
- Background: PubMed 12505962Casati A, Borghi B, Fanelli G, Montone N, Rotini R, Fraschini G, Vinciguerra F, Torri G, Chelly J. Interscalene brachial plexus anesthesia and analgesia for open shoulder surgery: a randomized, double-blinded comparison between levobupivacaine and ropivacaine. Anesth Analg. 2003 Jan;96(1):253-9, table of contents. doi: 10.1097/00000539-200301000-00051.
- Background: PubMed 17457131Casati A, Danelli G, Baciarello M, Corradi M, Leone S, Di Cianni S, Fanelli G. A prospective, randomized comparison between ultrasound and nerve stimulation guidance for multiple injection axillary brachial plexus block. Anesthesiology. 2007 May;106(5):992-6. doi: 10.1097/01.anes.0000265159.55179.e1.
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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.
Giorgio Danelli, MD principal investigator
UO II Anestesia, Rianimazione e Terapia Antalgica, AOU Parma
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 Ultrasound-guided continuous interscalene brachial plexus block, Continuous interscalene brachial plexus block using electrical nerve stimulation and Ropivacaine in people with Shoulder and Orthopedic Surgery, run by University of Parma at 1 site in Italy.
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 3 inclusion and 6 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 16 Nov 2009. 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 Italy. 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?
Onset time of brachial plexus anesthesia (time frame: ≤30 min). 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 NCT00702416, which also lists 4 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 16 Nov 2009.