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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
  Purpose

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.


Condition Intervention
Pain
Other: Epidural
Other: Local anaesthetic wound catheter

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Scarborough General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
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)
Arms Assigned Interventions
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.
Other: Epidural
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279980

Contacts
Contact: Eleanor R Richards, BM Medicine 0044723368111 ext 5324 errichards@doctors.org.uk

Locations
United Kingdom
Scarborough General Hospital Recruiting
Scarborough, North Yorkshire, United Kingdom, YO126QL
Contact: Mark Andrews, (Medical director)    00441723368111    Mark.Andrews@acute.sney.nhs.uk   
Principal Investigator: Eleanor R Richards, BM Medicine         
Sub-Investigator: Irfan Kabir, MBBS         
Sponsors and Collaborators
Scarborough General Hospital
Investigators
Principal Investigator: Eleanor R Richards, BM Medicine Scarborough General Hospital
  More Information

No publications provided

Responsible Party: Miss Eleanor Richards, Scarborough General Hospital
ClinicalTrials.gov Identifier: NCT01279980     History of Changes
Other Study ID Numbers: 10/H1308/63
Study First Received: January 19, 2011
Last Updated: February 17, 2011
Health Authority: United Kingdo: Research Ethics Committee

Keywords provided by Scarborough General Hospital:
ERAS
Local anaesthetic wound catheter
Painbuster
Epidural
colorectal surgery
enhanced recovery program

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014