Pain
Conditions
Keywords
ERAS, Local anaesthetic wound catheter, Painbuster, Epidural, colorectal surgery, enhanced recovery program
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.
Interventions
OTHEREpidural
Epidural analgesia inserted prior to surgery to stay in until at least the second postoperative day
OTHERLocal anaesthetic wound catheter
The catheter will be used to infuse the wound with local anaesthetic for 48 hours post op.
Sponsors
Scarborough General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | determined on discharge from hospital | Length of stay will be measured in days for each group.This will be determined by a set of predefined discharge criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Episodes of hypotension in the postoperative period | whilst an inpatient | This will be defined as a systolic blood pressure of less than 90 mmHg |
| Postoperative pain | as an inpatient | 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 | as an inpatient | This will be documented on each postoperative day. |
| Body composition | Tests will be performed daily until the epidural or Painbuster® has been removed. | 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 complications | Whilst an inpatient | 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 |
| Postoperative stress response | As an inpatient | This will be assessed using: SIRS criteria C reactive protein Indirect calorimetry on alternate days at a fixed time. |
| Anaesthetic time required | On the day of operation | he time taken in minutes for insertion of epidural or wound catheter will be recorded in each group. |
| Postoperative mobility | as an inpatient | 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 | As an inpatient | Return of gut function will be defined by the tolerance of \>/= 80% of the prescribed nutritional requirement. This will be assessed by a dietician. |
| Postoperative analgesic requirement | As an inpatient | 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. |
Countries
United Kingdom
Contacts
Primary ContactEleanor R Richards, BM Medicine
Outcome results
None listed