Ignite Creation Date:
2024-05-05 @ 11:37 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01374464
Status:
UNKNOWN
Last Update Posted:
2011-06-16
First Post:
2011-06-14
Brief Title:
Reducing Respiratory Side Effects of Interscalene Brachial Plexus Block
Sponsor:
Royal Surrey County Hospital NHS Foundation Trust
Organization:
Royal Surrey County Hospital NHS Foundation Trust
Study Overview
Official Title:
A Double Blind Randomised Control Trial Assessing Effects of Local Anaesthetic Concentration 05 vs 075 and Volume 5mls vs 15mls on the Respiratory Consequences of Ultrasound Guided Interscalene Brachial Plexus Nerve Block
Status:
UNKNOWN
Status Verified Date:
2011-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
1 Low concentration-high volume of local anaesthetic
2 Low concentration-low volume of local anaesthetic
3 High concentration-high volume of local anaesthetic
4 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
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
1 Low concentration-high volume of local anaesthetic
2 Low concentration-low volume of local anaesthetic
3 High concentration-high volume of local anaesthetic
4 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None