Open Radical Cystectomy Clinical Trial
Official 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
| NCT number | NCT03410186 |
| Other study ID # | EDGE102914 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 5, 2017 |
| Est. completion date | July 15, 2019 |
| Verified date | November 2019 |
| Source | University Hospitals, Leicester |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Background: Bowel dysfunction is a major complication following open surgery for invasive
cancer of the bladder that causes significant discomfort, complications 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 for cancer of the urinary 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 and this has become the standard of care
for our patients undergoing this surgery. The modified ERP care package includes a novel
combination of two established pain relief techniques (erector spinae plane analgesia and
intrathecal opioids) that will avoid the use of epidural analgesia, 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(open radical cystectomy Methods:
Prospective, observational pilot study that will be conducted at Leicester General Hospital
over 24 months. Adult patients scheduled to undergo open radical cystectomy will be included
in the study. Patients who will have laparoscopic surgery will be excluded. 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.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | July 15, 2019 |
| Est. primary completion date | June 15, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Adult patients scheduled to undergo open radical cystectomy 2. American Society of Anesthesiologists (ASA) 2 or 3 Exclusion Criteria: 1. Lack of consent including from those participants who lack mental capacity to give informed consent 2. American Society of Anesthesiologists (ASA) 4 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University Hospitals of Leicester NHS Trust | Leicester | Leicestershire |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospitals, Leicester |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The incidence of Post Operative Ileus (POI) | The incidence of postoperative ileus (POI): POI is defined as 'Intolerance of solid food at the 5th postoperative day with the need to hold oral nutrition because of bloating, nausea and vomiting' | 24 months | |
| Secondary | The length of hospital stay | Defined as duration from the day of surgery to the day the participant meets the following 4 criteria: Pain Free, Ambulant, Bowels Opened & Stoma Trained | 24 months |