Clinical Trial Comparing Epidurals and Local Anaesthetic Wound Catheters in Patients Having Bowel Surgery
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Continuous Wound Infiltration With Local Anaesthetic vs. Epidurals in an Enhanced Recovery Protocol: A Randomised Controlled Trial|
- Length of hospital stay [ Time Frame: determined on discharge from hospital ] [ Designated as safety issue: No ]Length of stay will be measured in days for each group.This will be determined by a set of predefined discharge criteria.
- Postoperative complications [ Time Frame: Whilst an inpatient ] [ Designated as safety issue: Yes ]
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
- Episodes of hypotension in the postoperative period [ Time Frame: whilst an inpatient ] [ Designated as safety issue: Yes ]This will be defined as a systolic blood pressure of less than 90 mmHg
- Postoperative pain [ Time Frame: as an inpatient ] [ Designated as safety issue: No ]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.
- Amount of postoperative IV fluid administered [ Time Frame: as an inpatient ] [ Designated as safety issue: No ]This will be documented on each postoperative day.
- Body composition [ Time Frame: Tests will be performed daily until the epidural or Painbuster® has been removed. ] [ Designated as safety issue: No ]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.
- Postoperative analgesic requirement [ Time Frame: As an inpatient ] [ Designated as safety issue: No ]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.
- Postoperative stress response [ Time Frame: As an inpatient ] [ Designated as safety issue: No ]
This will be assessed using:
SIRS criteria C reactive protein Indirect calorimetry on alternate days at a fixed time.
- Anaesthetic time required [ Time Frame: On the day of operation ] [ Designated as safety issue: No ]he time taken in minutes for insertion of epidural or wound catheter will be recorded in each group.
- Postoperative mobility [ Time Frame: as an inpatient ] [ Designated as safety issue: No ]
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.
- Day of return of gut function [ Time Frame: As an inpatient ] [ Designated as safety issue: No ]Return of gut function will be defined by the tolerance of >/= 80% of the prescribed nutritional requirement. This will be assessed by a dietician.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Epidural
Subjects will have an epidural catheter placed to provide postoperative pain relief. This is standard care for those undergoing an enhanced recovery program.
Epidural analgesia inserted prior to surgery to stay in until at least the second postoperative day
Active Comparator: Painbuster
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
The catheter will be used to infuse the wound with local anaesthetic for 48 hours post op.
Other Name: Painbuster(registered trademark)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279980
|Scarborough General Hospital|
|Scarborough, North Yorkshire, United Kingdom, YO126QL|
|Principal Investigator:||Eleanor R Richards, BM Medicine||Scarborough General Hospital|