Clinical Trial Comparing Epidurals and Local Anaesthetic Wound Catheters in Patients Having Bowel Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Continuous Wound Infiltration With Local Anaesthetic vs. Epidurals in an Enhanced Recovery Protocol: A Randomised Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Other: Epidural
* Other: Local anaesthetic wound catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who are undergoing either laparoscopic or open colorectal resection will be considered eligible for the study. Exclusion Criteria: Patients under 18 years of age Pregnant females Patients undergoing an abdominoperineal resection Patients unable to understand English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural<br>Subjects will have an epidural catheter placed to provide postoperative pain relief. This is standard care for those undergoing an enhanced recovery program. | Other: Epidural<br>* Epidural analgesia inserted prior to surgery to stay in until at least the second postoperative day<br>|
| Active Comparator: Painbuster<br>Subjects 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. | Other: Local anaesthetic wound catheter<br>* The catheter will be used to infuse the wound with local anaesthetic for 48 hours post op.<br>* Other names: Painbuster(registered trademark);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | All complications in the postoperative period will be recorded. Particular emphasis will be given to: Wound infection: this will be defined as clinical evidence of purulent discharge and erythema accompanied by microbiological (culture of microorganisms) and haematological evidence (raised white cell count) Cardiac failure: This will be defined as the presence of clinical signs of fluid overload accompanied by radiological features on a chest X-Ray. Complications related to epidural/spinal Adequacy of deep vein thrombosis prophylaxis | Whilst an inpatient | 
| Episodes of hypotension in the postoperative period | This will be defined as a systolic blood pressure of less than 90 mmHg | whilst an inpatient | 
| Postoperative pain | This will be assessed objectively using the visual analogue scale for pain. Measurements will be taken twice a day for as long as the epidural catheter or Painbuster® is in situ. Pain scores will be measured at rest and on coughing. | as an inpatient | 
| Amount of postoperative IV fluid administered | This will be documented on each postoperative day. | as an inpatient | 
| Body composition | Body composition (Fat Mass, Fat Free Mass, Extracellular Fluid Volume, Intracellular Fluid Volume, and Total Body Water) will be determined using a bioelectrical impedence analysis (BIA) machine, specifically the Bodystat machine. | Tests will be performed daily until the epidural or Painbuster® has been removed. | 
| Postoperative analgesic requirement | The total quantity and type (opiate or non-opiate) of all analgesics administered during the period when epidurals or Painbuster® was in situ will be recorded. | As an inpatient | 
| Postoperative stress response | This will be assessed using: SIRS criteria C reactive protein Indirect calorimetry on alternate days at a fixed time. | As an inpatient | 
| Anaesthetic time required | he time taken in minutes for insertion of epidural or wound catheter will be recorded in each group. | On the day of operation | 
| Postoperative mobility | Postoperative mobility will be assessed as time until sit to stand aided and unaided, duration of time spent out of bed on each postoperative day and maximum walking distance with assistance on a daily basis. In addition, assessment of mobilisation will be carried out by the physiotherapists who will record this in patient notes. All patients will be given pedometer to wear which will count the number of steps taken. Pedometer readings will be taken twice a day. Pedometers have been previously validated as an objective measurement of mobility. | as an inpatient | 
| Day of return of gut function | Return of gut function will be defined by the tolerance of >/= 80% of the prescribed nutritional requirement. This will be assessed by a dietician. | As an inpatient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS, Local anaesthetic wound catheter, Painbuster, Epidural, colorectal surgery, enhanced recovery program