ESP analgesia within an ERP in Open Radical Cystectomy
Research type
Research Study
Full title
Effectiveness of a continuous paravertebral analgesia via erector spinae plane (ESP) catheters within a strict enhanced recovery protocol (ERP) in adult patients following open radical cystectomy (ORC): an observational pilot study
IRAS ID
235001
Contact name
Niraj Gopinath
Contact email
Sponsor organisation
University Hospitals of Leicester NHS Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Background: Bowel dysfunction (constipation) is a major complication following open surgery for invasive cancer of the bladder that causes significant discomfort, complications (vomiting, aspiration of stomach contents into lungs) and prolongs the length of stay in the hospital. Amenable factors that are responsible for postoperative bowel dysfunction include intravenous morphine given for pain relief and epidural infusion requiring excess intravenous fluids administration after surgery. The British Association of Urological Surgeons (BAUS) have published the Enhanced Recovery protocol (ERP) to reduce length of hospital stay following open surgery on the bladder. The ERP is a care package that is provided to the patient from the day of the surgery till hospital discharge. At Leicester, we have modified the ERP to include a novel combination of two established pain relief techniques (paravertebral block via erector spinae plane and spinal morphine) that will avoid the use of epidural catheter, excess intravenous fluids administration and intravenous morphine in the postoperative period. The modified ERP has been well accepted by the patients and the clinical team looking after these patients. We would like to perform a formal evaluation of the modified ERP care package in the management of adult patients undergoing open bladder surgery through an observational pilot study.
Aim of the study is to evaluate the incidence of postoperative bowel dysfunction and the median length of hospital stay in adult patients undergoing major open urinary bladder surgery (open radical cystectomy)
Methods: The proposed study is a prospective, observational pilot study that will be conducted at Leicester General Hospital over 24 months. Adult patients scheduled to undergo major open surgery for invasive cancer of their urinary bladder will be included in the study. Patients who will have keyhole surgery will be excluded form the study. After providing written consent, the participants will receive an enhanced recovery protocol (ERP) care package that will commence from the day of their surgery till they are discharged from the hospital. Participants will be asked to report time of opening their bowel, pain scores on movement, presence of nausea and vomiting, bowel dysfunction, length of hospital stay and any complication from day of surgery till 30 days after surgery. Participation in the study will end at 30 days after surgery.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
17/YH/0380
Date of REC Opinion
7 Nov 2017
REC opinion
Favourable Opinion