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Effectiveness of Continuous Erector Spinae Plane and Intrathecal Opioid (ESPITO) Analgesia in Open Radical Cystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03410186
Recruitment Status : Completed
First Posted : January 25, 2018
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospitals, Leicester

Study Description
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Brief Summary:

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.


Condition or disease
Open Radical Cystectomy

Study Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : December 5, 2017
Actual Primary Completion Date : June 15, 2019
Actual Study Completion Date : July 15, 2019
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. The incidence of Post Operative Ileus (POI) [ Time Frame: 24 months ]
    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'


Secondary Outcome Measures :
  1. The length of hospital stay [ Time Frame: 24 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study is based on a cohort of adult patients scheduled to undergo elective open radical cystectomy for muscle invasive carcinoma of the urinary bladder.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410186


Locations
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United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE54PW
Sponsors and Collaborators
University Hospitals, Leicester
More Information
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Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT03410186    
Other Study ID Numbers: EDGE102914
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No