Clinical Trial Comparing Epidurals and Local Anaesthetic Wound Catheters in Patients Having Bowel Surgery
Continuous Wound Infiltration With Local Anaesthetic vs. Epidurals in an Enhanced Recovery Protocol: A Randomised Controlled Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to find out whether the use of Painbuster® (a local anaesthetic wound catheter) can be used instead of epidurals for patients having bowel surgery in an enhanced recovery programme. The investigators want to find out whether or not using this device means people need to stay in hospital for less time after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Feb 2011
Typical duration for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2011
CompletedFirst Posted
Study publicly available on registry
January 20, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFebruary 18, 2011
February 1, 2011
1.4 years
January 19, 2011
February 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of hospital stay
Length of stay will be measured in days for each group.This will be determined by a set of predefined discharge criteria.
determined on discharge from hospital
Secondary Outcomes (10)
Postoperative complications
Whilst an inpatient
Episodes of hypotension in the postoperative period
whilst an inpatient
Postoperative pain
as an inpatient
Amount of postoperative IV fluid administered
as an inpatient
Body composition
Tests will be performed daily until the epidural or Painbuster® has been removed.
- +5 more secondary outcomes
Study Arms (2)
Epidural
ACTIVE COMPARATORSubjects will have an epidural catheter placed to provide postoperative pain relief. This is standard care for those undergoing an enhanced recovery program.
Painbuster
ACTIVE COMPARATORSubjects will have a local anaesthetic wound catheter inserted into the wound at time of surgery rather than an epidural for the provision of postoperative pain relief.
Interventions
Epidural analgesia inserted prior to surgery to stay in until at least the second postoperative day
The catheter will be used to infuse the wound with local anaesthetic for 48 hours post op.
Eligibility Criteria
You may qualify if:
- All patients who are undergoing either laparoscopic or open colorectal resection will be considered eligible for the study.
You may not qualify if:
- Patients under 18 years of age
- Pregnant females
- Patients undergoing an abdominoperineal resection
- Patients unable to understand English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Scarborough General Hospital
Scarborough, North Yorkshire, YO126QL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eleanor R Richards, BM Medicine
Scarborough General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 19, 2011
First Posted
January 20, 2011
Study Start
February 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
February 18, 2011
Record last verified: 2011-02