Adverse Reaction to Peripheral Nerve- and Plexus-blocking AnestheticsPhase 4NCT01374464
Reducing Respiratory Side Effects of Interscalene Brachial Plexus Block
A Phase 4 study testing Interscalene brachial plexus block in people with Adverse Reaction to Peripheral Nerve- and Plexus-blocking Anesthetics, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Shoulder surgery is known to be extremely painful requiring high doses of opiate analgesics (morphine) to control pain. Morphine has numerous unwanted side effects including sedation, hallucinations and vomiting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adverse Reaction to Peripheral Nerve- and Plexus-blocking Anesthetics
- What is being tested?
- Interscalene brachial plexus block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Mar 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing day case shoulder surgery that would normally be managed with a nerve block for post-operative pain relief will be considered eligible for the study. Inclusion criteria are detailed below
- Age > 18 and < 80 years
- American Society of Anaesthetists (ASA) grades I - III. (ASA grade determines how 'fit' a patient is for surgery, with 1 being a normal healthy patient and 5 being a moribund patient that is not expected to survive. 'Fitter' patients are being chosen as it is felt that severe associated illness may influence our results).
- A composite pain score of 0 when assessed in the post anaesthetic care unit (PACU) at 30mins post-operatively. This will be required in order for the patient to be deemed to have an 'effective' nerve block and be entered into the study. Patients reporting pain at this point will be removed from the study and offered either a rescue brachial plexus block or alternative analgesia. (Published research by Riazi et al and by McNaught et al, indicates that 5mls of local anaesthetic solution is adequate for establishing an effective ISBPB in this immediate post-operative period).
Who cannot join
- Significant respiratory disease including Chronic Obstructive Pulmonary Disease or unstable asthma
- Renal or hepatic impairment
- Allergy to local anaesthetic
- Opiod tolerance (more then 30mg of morphine or its equivalent per day)
- Body mass index > 40
- Body weight < 56kg (due to potentially toxic doses of local anaesthetic drug if using higher volume of 0.75% concentration at below this weight)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX
Michele Kigozi, BMedSci,BMBS
About this study
Official title: A Double Blind Randomised Control Trial Assessing Effects of Local Anaesthetic Concentration (0.5% vs 0.75%) and Volume (5mls vs 15mls) on the Respiratory Consequences of Ultrasound Guided Interscalene Brachial Plexus Nerve Block
Shoulder surgery is known to be extremely painful requiring high doses of opiate analgesics (morphine) to control pain. Morphine has numerous unwanted side effects including sedation, hallucinations and vomiting.
It is now standard procedure for patients undergoing shoulder surgery to have their pain controlled by means of an injection made around the nerves where they pass through the neck to supply the shoulder with sensation (similar to the numbing injections made by the dentist before a dental procedure). This injection is called a 'nerve block'.
Read more
Nerve blocks provide complete analgesia after shoulder surgery allowing clinicians to discharge patients home on the day of surgery, pain free and with no opiate side effects. However, a side effect of nerve blocks at this level is involvement of the phrenic nerve, which is anatomically close to the injection point. This may cause (temporary) paralysis of the diaphragm and in some cases, severe respiratory dysfunction.
Research shows that reducing either the volume or the concentration of the drug injected, can reduce the consequent respiratory dysfunction. However no study has compared both volume and concentration in parallel, to see which of these has the more significant effect in reducing respiratory dysfunction. Furthermore there has been no assessment of how these changes may affect the duration of analgesia received and patient coping after discharge.
The investigators propose to conduct a double blind randomised controlled trial at the Royal Surrey County Hospital, enrolling patients presenting for elective day case arthroscopic (key hole) surgery over a period of 6 months. Patients will receive one of four treatment allocations:
- Low concentration-high volume of local anaesthetic
- Low concentration-low volume of local anaesthetic
- High concentration-high volume of local anaesthetic
- High concentration-low volume of anaesthetic drug of local anaesthetic.
The aim of this study is to inform an optimum dosing regimen for patients in order to facilitate maximal pain relief and quality of recovery with minimum respiratory dysfunction.
- Being tested
- Interscalene brachial plexus block
- Keywords
- Interscalene brachial plexus nerve block, Nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus blockOther
Also called Levobupivicaine, Chirocaine
4 different administrations of levobupivicaine will be applied:
- High Volume, High Concentration = 15mls of 0.75% levobupivicaine
- High Volume, Low Concentration = 15mls of 0.5% levobupivicaine
- Low Volume, High Concentration = 5mls of 0.75% levobupivicaine
- Low Volume, Low Concentration = 5mls of 0.5% levobupivicaine
| Study group | Role | What they receive |
|---|---|---|
| High Volume, High Concentration | Active comparator | Not described Receives: Other: Interscalene brachial plexus block |
| High Volume, Low Concentration | Active comparator | Not described Receives: Other: Interscalene brachial plexus block |
| Low Volume, High Concentration | Active comparator | Not described Receives: Other: Interscalene brachial plexus block |
| Low Volume, Low Concentration | Active comparator | Not described Receives: Other: Interscalene brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Functional Vital Capacity post interscalene brachial plexus block
The functional vital capacity refers to the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Measuring FVC is done by spirometry.
Measured: 30 minutes after waking in post operative care unit
Secondary outcomes (1)
Quality of recovery from surgery
By means of a quality of recovery questionnaire
Measured: First 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study startAug 2012
- Primary completionFeb 2013 (estimated)
- Study completionMar 2013 (estimated)
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 Adverse Reaction to Peripheral Nerve- and Plexus-blocking AnestheticsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Gillian Foxall, MBChB, MA, Principal investigator, Royal Surrey County Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374464
- Sponsor's protocol ID
- 11/LO/0934
- Status last verified
- Jun 2011
- First submitted
- 14 Jun 2011
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
PubMed 2006740Riazi S, Carmichael N, Awad I, Holtby RM, McCartney CJ. Effect of local anaesthetic volume (20 vs 5 ml) on the efficacy and respiratory consequences of ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2008 Oct;101(4):549-56. doi: 10.1093/bja/aen229. Epub 2008 Aug 4.
PubMed 18682410McNaught A, Shastri U, Carmichael N, Awad IT, Columb M, Cheung J, Holtby RM, McCartney CJ. Ultrasound reduces the minimum effective local anaesthetic volume compared with peripheral nerve stimulation for interscalene block. Br J Anaesth. 2011 Jan;106(1):124-30. doi: 10.1093/bja/aeq306. Epub 2010 Nov 8.
PubMed 21059701al-Kaisy AA, Chan VW, Perlas A. Respiratory effects of low-dose bupivacaine interscalene block. Br J Anaesth. 1999 Feb;82(2):217-20. doi: 10.1093/bja/82.2.217.
PubMed 10364997
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomised Control Trial Assessing Effects of Local Anaesthetic Concentration (0.5% vs 0.75%) and Volume (5mls vs 15mls) on the Respiratory Consequences of Ultrasound Guided Interscalene Brachial Plexus Nerve Block
- ClinicalTrials.gov ID
- NCT01374464
- Acronym / sponsor ID
- 11/LO/0934
- Keywords
- Interscalene brachial plexus nerve block, Nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 16 Jun 2011 (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.
Shoulder surgery is known to be extremely painful requiring high doses of opiate analgesics (morphine) to control pain. Morphine has numerous unwanted side effects including sedation, hallucinations and vomiting.
It is now standard procedure for patients undergoing shoulder surgery to have their pain controlled by means of an injection made around the nerves where they pass through the neck to supply the shoulder with sensation (similar to the numbing injections made by the dentist before a dental procedure). This injection is called a 'nerve block'.
Nerve blocks provide complete analgesia after shoulder surgery allowing clinicians to discharge patients home on the day of surgery, pain free and with no opiate side effects. However, a side effect of nerve blocks at this level is involvement of the phrenic nerve, which is anatomically close to the injection point. This may cause (temporary) paralysis of the diaphragm and in some cases, severe respiratory dysfunction.
Research shows that reducing either the volume or the concentration of the drug injected, can reduce the consequent respiratory dysfunction. However no study has compared both volume and concentration in parallel, to see which of these has the more significant effect in reducing respiratory dysfunction. Furthermore there has been no assessment of how these changes may affect the duration of analgesia received and patient coping after discharge.
The investigators propose to conduct a double blind randomised controlled trial at the Royal Surrey County Hospital, enrolling patients presenting for elective day case arthroscopic (key hole) surgery over a period of 6 months. Patients will receive one of four treatment allocations:
- Low concentration-high volume of local anaesthetic
- Low concentration-low volume of local anaesthetic
- High concentration-high volume of local anaesthetic
- High concentration-low volume of anaesthetic drug of local anaesthetic.
The aim of this study is to inform an optimum dosing regimen for patients in order to facilitate maximal pain relief and quality of recovery with minimum respiratory dysfunction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Volume, High Concentration | Active comparator | Other: Interscalene brachial plexus block |
| High Volume, Low Concentration | Active comparator | Other: Interscalene brachial plexus block |
| Low Volume, High Concentration | Active comparator | Other: Interscalene brachial plexus block |
| Low Volume, Low Concentration | Active comparator | Other: Interscalene brachial plexus block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients undergoing day case shoulder surgery that would normally be managed with a nerve block for post-operative pain relief will be considered eligible for the study. Inclusion criteria are detailed below
- Age > 18 and < 80 years
- American Society of Anaesthetists (ASA) grades I - III. (ASA grade determines how 'fit' a patient is for surgery, with 1 being a normal healthy patient and 5 being a moribund patient that is not expected to survive. 'Fitter' patients are being chosen as it is felt that severe associated illness may influence our results).
- A composite pain score of 0 when assessed in the post anaesthetic care unit (PACU) at 30mins post-operatively. This will be required in order for the patient to be deemed to have an 'effective' nerve block and be entered into the study. Patients reporting pain at this point will be removed from the study and offered either a rescue brachial plexus block or alternative analgesia. (Published research by Riazi et al and by McNaught et al, indicates that 5mls of local anaesthetic solution is adequate for establishing an effective ISBPB in this immediate post-operative period).
Key exclusion criteria (6 listed)
- Significant respiratory disease including Chronic Obstructive Pulmonary Disease or unstable asthma
- Renal or hepatic impairment
- Allergy to local anaesthetic
- Opiod tolerance (more then 30mg of morphine or its equivalent per day)
- Body mass index > 40
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 brachial plexus blockAlso: Levobupivicaine, Chirocaine4 different administrations of levobupivicaine will be applied: 1. High Volume, High Concentration = 15mls of 0.75% levobupivicaine 2. High Volume, Low Concentration = 15mls of 0.5% levobupivicaine 3. Low Volume, High Concentration = 5mls of 0.75% levobupivicaine 4. Low Volume, Low Concentration = 5mls of 0.5% levobupivicaine | Other | High Volume, High Concentration, High Volume, Low Concentration, Low Volume, High Concentration, Low Volume, Low Concentration |
Primary outcome
Change from baseline in Functional Vital Capacity post interscalene brachial plexus block
Time frame: 30 minutes after waking in post operative care unit
The functional vital capacity refers to the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Measuring FVC is done by spirometry.
1 secondary outcome
Quality of recovery from surgery
Time frame: First 24 hours post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
- Background: PubMed 2006740Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
- Background: PubMed 18682410Riazi S, Carmichael N, Awad I, Holtby RM, McCartney CJ. Effect of local anaesthetic volume (20 vs 5 ml) on the efficacy and respiratory consequences of ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2008 Oct;101(4):549-56. doi: 10.1093/bja/aen229. Epub 2008 Aug 4.
- Background: PubMed 21059701McNaught A, Shastri U, Carmichael N, Awad IT, Columb M, Cheung J, Holtby RM, McCartney CJ. Ultrasound reduces the minimum effective local anaesthetic volume compared with peripheral nerve stimulation for interscalene block. Br J Anaesth. 2011 Jan;106(1):124-30. doi: 10.1093/bja/aeq306. Epub 2010 Nov 8.
- Background: PubMed 10364997al-Kaisy AA, Chan VW, Perlas A. Respiratory effects of low-dose bupivacaine interscalene block. Br J Anaesth. 1999 Feb;82(2):217-20. doi: 10.1093/bja/82.2.217.
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.
Gillian Foxall, MBChB, MA principal investigator
Royal Surrey County Hospital NHS Foundation Trust
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 brachial plexus block in people with Adverse Reaction to Peripheral Nerve- and Plexus-blocking Anesthetics, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 4 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: status not confirmed, as of the sponsor's last update on 16 Jun 2011. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gillian Foxall, MBChB, MA (07917865767, gillianfoxall@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Functional Vital Capacity post interscalene brachial plexus block (time frame: 30 minutes after waking in post operative care unit). 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 NCT01374464, 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 Jun 2011.