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

Not Applicable

• Conditions: Pain
• Interventions: Other: Epidural; Other: Local anaesthetic wound catheter

• Registration Number: NCT01279980
• Lead Sponsor: Scarborough General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-19
• Study First Posted: 2011-01-20
• Status Verified: 2011-02
• Study Start: 2011-02
• Last Update Submitted: 2011-02-17
• Last Update Posted: 2011-02-18
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural	Epidural	Subjects will have an epidural catheter placed to provide postoperative pain relief. This is standard care for those undergoing an enhanced recovery program.
Painbuster	Local anaesthetic wound catheter	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 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.
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.

Trial Locations

Locations (1)

Scarborough General Hospital; 🇬🇧 Scarborough, North Yorkshire, United Kingdom