Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03137732
Status:
UNKNOWN
Last Update Posted:
2017-05-03
First Post:
2017-04-26
Brief Title:
Surgical Versus Anaesthetic Placement of Rectus Sheath Catheters
Sponsor:
Countess of Chester NHS Foundation Trust
Organization:
Countess of Chester NHS Foundation Trust
Study Overview
Official Title:
Surgical Placement Versus Anaesthetic Placement of Rectus Sheath Catheter for Pain Relief Following Major Abdominal Surgery SPARC A Single Centre Randomised Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2017-04
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:
SPARC
Brief Summary:
This is a single centred randomized controlled trial comparing surgeon versus anaesthetist inserted rectus sheath catheters for management of analgesia post major abdominal surgery
Detailed Description:
Background and study aims Pain management post laparotomy abdominal surgery can be difficult and in our trust we are increasingly using rectus sheath catheters RSCsThis is achieved by placing catheters done by either by the surgeon or anaesthetist into the potential space between the rectus muscle and the posterior rectus sheath Two catheters are placed one on either side of the mid-line wound Local anaesthetic is then infused through the catheters for up to 3 days post-operatively This provides analgesia to the central abdominal wall in the region of the T7-T11 dermatomes It only provides analgesia for somatic pain not visceral pain and hence needs to be used in addition to a multi-modal analgesic regime usually including a patient controlled analgesia device PCA containing either morphine or oxycodone Advantages of a RSC infusion over an epidural include that it can be used in patients with coagulopathy or systemic infection and can be safely performed asleep It is also less labour intensive to manage on the ward and does not carry the same risks of hypotension and excessive fluid administration that are associated with an epidural
There is randomised controlled trial evidence that RSC infusions in addition to PCA provide superior analgesia when compared to PCA alone in surgery performed through a midline incision There is also a randomised controlled trial in progress that is comparing analgesic quality of epidural infusions to RSC with PCA In most published literature to date RSC are inserted by the anaesthetist using ultrasound to aid placement In our hospital some RSC are inserted by anaesthetists although the majority are performed by surgeons at the end of an operation This is because we believe that this technique is less time consuming and both insertion techniques result in equivalent analgesia
The primary aim endpoint of this study is to determine any difference in insertion time for rectus sheath catheters between those inserted by surgeons and those inserted by anaesthetists Observationally in our hospital there is no difference in quality of analgesia provided by the two insertion techniques However surgical insertion of RSC causes less disruption of an operation as the patient already has their abdomen draped with sterilised skin as part of their surgical procedure Also surgical insertion of RSC with an open abdomen is potentially easier than ultrasound guided insertion by an anaesthetist before an operation
Who can participate Any adults undergoing emergency or elective laparotomy major abdominal surgery What does the study involve All participants will receive rectus sheath catheters but will be randomly allocated to each group Following the surgery participants will have to answer questions about their pain on 3 consecutive days
What are the possible benefits and risks of participating There are no specific benefits to patients and the risks are the same if they were in the trial or not as it is routine in our hospital to use rectus sheath catheters as a means of analgesia post laparotomy These risks include bleeding dislodgement of catheter and failure of catheter and are low risk
Where is the study run from This a single centre study at the Countess of Chester Hospital in the United Kingdom
When is study starting and how long is it expected to run for We anticipate recruiting patient from June 2017 for 6 months How long will the trial be recruiting participants for No funding is required as all data collection will be carried out by doctors working in the departments but the study is being supported and supervised by the Hospitals Research and Development department
There is randomised controlled trial evidence that RSC infusions in addition to PCA provide superior analgesia when compared to PCA alone in surgery performed through a midline incision There is also a randomised controlled trial in progress that is comparing analgesic quality of epidural infusions to RSC with PCA In most published literature to date RSC are inserted by the anaesthetist using ultrasound to aid placement In our hospital some RSC are inserted by anaesthetists although the majority are performed by surgeons at the end of an operation This is because we believe that this technique is less time consuming and both insertion techniques result in equivalent analgesia
The primary aim endpoint of this study is to determine any difference in insertion time for rectus sheath catheters between those inserted by surgeons and those inserted by anaesthetists Observationally in our hospital there is no difference in quality of analgesia provided by the two insertion techniques However surgical insertion of RSC causes less disruption of an operation as the patient already has their abdomen draped with sterilised skin as part of their surgical procedure Also surgical insertion of RSC with an open abdomen is potentially easier than ultrasound guided insertion by an anaesthetist before an operation
Who can participate Any adults undergoing emergency or elective laparotomy major abdominal surgery What does the study involve All participants will receive rectus sheath catheters but will be randomly allocated to each group Following the surgery participants will have to answer questions about their pain on 3 consecutive days
What are the possible benefits and risks of participating There are no specific benefits to patients and the risks are the same if they were in the trial or not as it is routine in our hospital to use rectus sheath catheters as a means of analgesia post laparotomy These risks include bleeding dislodgement of catheter and failure of catheter and are low risk
Where is the study run from This a single centre study at the Countess of Chester Hospital in the United Kingdom
When is study starting and how long is it expected to run for We anticipate recruiting patient from June 2017 for 6 months How long will the trial be recruiting participants for No funding is required as all data collection will be carried out by doctors working in the departments but the study is being supported and supervised by the Hospitals Research and Development department
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