Title: A pilot prospective randomised controlled trial of Thoracic Epidural Analgesia (TEA) versus Rectus Sheath Catheters (RSC) for open midline incisions in major abdominal surgery within an Enhanced Recovery Programme (TERSC)
Funder: Department of Health (England)

Abstract: Background: The common method for providing pain relief after abdominal operations requiring a vertical incision is a thoracic epidural (TEA). The epidural blocks the nerve supply to the whole abdomen, numbing the wound and internal pain. TEA can provide very effective pain relief but is associated with rare and serious complications such as lowering blood pressure (hypotension) in 11-14% of patients. Hypotension often requires fluid IVs which can lead to further delay in the bowels working (a common complication after bowel surgery and the reason for delayed patient recovery). Importantly, 25-40% of epidurals fail within the first 48 hours following surgery. This occurs for a number of reasons (e.g., disconnections or displacement of the epidural tubes due to patient movement or staff reducing local anaesthetic due to hypotension). Further, some epidurals require replacement or removal and patients given a different kind of pain relief (e.g., morphine) which significantly adds to staff time and patient complications. We have introduced a technique called 'rectus sheath catheter' (RSC). This technique utilises ultrasound to accurately place catheters for the administering of local anaesthetic between the muscle layers of the abdominal wall. This completely blocks pain to the wound in the abdomen by numbing nerves supplying sensation to this area and is the source of most reported long-lasting pain after surgery. Small amounts of morphine-type medication are needed for a period following surgery to relieve internal (visceral) pain; we use a pain-relieving skin patch for this purpose. There are no reports of RSCs leading to complications associated with epidurals, they do not cause hypotension and have a high success rate with failure due to disconnection or displacement measured at only 5% in our Trust. Importantly, this new technique is currently in extremely limited use in the NHS and no research has been undertaken to determine which technique provides the best form of pain relief following major abdominal surgery. One study is currently examining RSCs in a small trial but this study has insufficient numbers, does not include all abdominal surgery and manages RSCs in a manner that would be difficult to implement across the NHS. Aims: We will conduct a prospective clinical trial to determine which technique (TEA or RSC) provides the best form of pain relief, patient experience and safety profile following major abdominal surgery. We will collect measures of functional recovery, quality of life and calculate cost effectiveness for use in a larger, planned multi-centre study. Plan of investigation: Adult patients receiving elective open major abdominal surgery (including upper and lower gastrointestinal surgery and radical cystectomies) with a vertical incision will be allocated at random to receive pain relief via either TEA or RSC. If the assigned intervention fails the patient will be given morphine through a drip to stop any discomfort (usual practice for failed TEA). Information will be collected about the quality of pain relief, side effects, recovery and any complications during the operation and afterwards until discharge or up to 30 days. Patient experience will be assessed through qualitative interviews and health economic costs will be assessed for a planned, multi-centre study. Benefits: RSCs may bring benefits to patients and the NHS in the form of improvements in quality of pain relief, fewer complications and better functional recovery with improved patient experience, better bed usage and improved cost effectiveness. This would have great benefit if implemented across the NHS (29577 major colorectal cancer resections annually) [50], with benign resections, upper GI and major urology accounting for a further equally large volume of surgery) for patients, staff in terms of satisfaction and management time and the health economy as a whole.


Research activity codes: 6.4 SURGERY
Health categories: ORAL AND GASTROINTESTINAL