Pain, Postoperative Clinical Trial
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
This is a single centred randomized controlled trial comparing surgeon versus anaesthetist inserted rectus sheath catheters for management of analgesia post major abdominal surgery.
Background and study aims Pain management post laparotomy (abdominal surgery) can be
difficult and in our trust we are increasingly using rectus sheath catheters (RSCs).This 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 Hospital's Research and
Development department.
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