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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Scarborough General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Scarborough General Hospital
ClinicalTrials.gov Identifier:
NCT01279980
First received: January 19, 2011
Last updated: February 17, 2011
Last verified: February 2011

January 19, 2011
February 17, 2011
February 2011
July 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01279980 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
  • Other: Epidural
    Epidural analgesia inserted prior to surgery to stay in until at least the second postoperative day
  • 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)
  • 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.
    Intervention: Other: Epidural
  • 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.
    Intervention: Other: Local anaesthetic wound catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Eleanor R Richards, BM Medicine 0044723368111 ext 5324 errichards@doctors.org.uk
United Kingdom
 
NCT01279980
10/H1308/63
Yes
Miss Eleanor Richards, Scarborough General Hospital
Scarborough General Hospital
Not Provided
Principal Investigator: Eleanor R Richards, BM Medicine Scarborough General Hospital
Scarborough General Hospital
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP