Ignite Creation Date:
2024-05-06 @ 1:02 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03919916
Status:
UNKNOWN
Last Update Posted:
2021-06-02
First Post:
2019-04-08
Brief Title:
Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia in Rib Fractures
Sponsor:
Chelsea and Westminster NHS Foundation Trust
Organization:
Chelsea and Westminster NHS Foundation Trust
Study Overview
Official Title:
Comparison of Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia Alone in Acute Rib fracturEs
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
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:
COPE
Brief Summary:
In this multicentre randomised controlled trial adult patients with isolated chest trauma and two or more unilateral rib fractures will be randomised to either serratus plane block and patient controlled analgesia or patient controlled analgesia alone Our primary outcome is the static visual analogue scale score at one hour
Detailed Description:
Rib breaks or fractures can cause pain that can be very difficult to manage and can result in chest infection and death Such pain can be managed with either systemic drugs like morphine which are given by mouth or through the veins or local anaesthetic techniques which can numb the painful area Use of systemic drugs is however limited by significant side effects and traditional local anaesthetic techniques have problems of their own Epidural analgesia where local anaesthetic is placed near the spine can only be done by those with a high level of technical skill and cannot be performed in patients with spine injuries positioning difficulties and clotting problems Complications and side effects can be common andor serious and include failure fall in blood pressure and nerve and spinal cord damage More recently there has been interest in a new local anaesthetic technique serratus plane block Serratus plane block is simple to learn and can be done without any need for repositioning of the patient It avoids some of the complications and side effects related to other local anaesthetic techniques and is more easily looked after by nursing staff on the ward In view of this we are aiming to recruit 44 adults with isolated chest injury and two or more rib fractures on one side Each patient will either receive a serratus plane block in conjunction with morphine through the veins or just morphine alone Our main aim is to assess how bad the pain is at 1 hour but we will also compare the pain score morphine consumption lung function level of sleepiness and the frequency of low blood pressure nausea and vomiting and slow breathing over the first 72 hours as well as the hospital length of stay and occurrence of lung infection within 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None