Clinical Trial: Surgical Versus Anaesthetic Placement of Rectus Sheath Catheters

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.

This will be recorded in theatre on a stopwatch and recorded.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain scores [ Time Frame: 4 days ]
    Patients will be asked to score their pain in recovery and on days 0,1,2,3 post operatively. This will be graded using a Numeric Pain Rating Scale.
  • Peri-operative analgesic use [ Time Frame: 4 days ]
    Analgesic use intra-operatively and post-operatively for 3 days. This will include strong opioids, paracetamol, NSAIDs, codeine, ketamine, IV lignocaine, tramadol, clonidine and PCA usage post-operatively.
  • Catheter issues [ Time Frame: 4 days ]
    This includes haemorrhage, dislodgement, blockage
  • Duration of catheter use [ Time Frame: 4 days ]
  • TIme to diet and mobilisation [ Time Frame: likely 1-3 days ]
  • Time to discharge [ Time Frame: approximately 7 days ]


Original Secondary Outcome: Same as current

Information By: Countess of Chester NHS Foundation Trust

Dates:
Date Received: April 26, 2017
Date Started: June 2017
Date Completion: June 2018
Last Updated: April 28, 2017
Last Verified: April 2017