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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Volume, High Concentration | Active Comparator |
| |
| High Volume, Low Concentration | Active Comparator |
| |
| Low Volume, High Concentration | Active Comparator |
| |
| Low Volume, Low Concentration | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interscalene brachial plexus block | Other | 4 different administrations of levobupivicaine will be applied:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes after waking in post operative care unit |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of recovery from surgery | By means of a quality of recovery questionnaire | First 24 hours post-operatively |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gillian Foxall, MBChB, MA | Contact | 07917865767 | gillianfoxall@nhs.net | |
| Michele N Kigozi, BMedSci,BMBS | Contact | 07977165224 | nabakka@btinternet.com |
| Name | Affiliation | Role |
|---|---|---|
| Gillian Foxall, MBChB, MA | Royal Surrey County Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Surrey County Hospital | Guildford | Surrey | GU2 7XX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2006740 | Background | 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. | |
| 18682410 | Background | Riazi 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. |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 21059701 | Background | McNaught 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. |
| 10364997 | Background | al-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. |
| Aniline Compounds |
| D000588 | Amines |