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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Other: Epidural; Other: Local anaesthetic wound catheter

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eleanor R Richards, BM Medicine; Phone Number: 5324 0044723368111; Email: errichards@doctors.org.uk

Study Locations

• United Kingdom
  • North Yorkshire
    • Scarborough, North Yorkshire, United Kingdom, YO126QL
      • Recruiting
      • Scarborough General Hospital
      • Contact: Mark Andrews, (Medical director); Phone Number: 00441723368111; Email: Mark.Andrews@acute.sney.nhs.uk
      • Principal Investigator: Eleanor R Richards, BM Medicine
      • Sub-Investigator: Irfan Kabir, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Painbuster(registered trademark)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Length of stay will be measured in days for each group.This will be determined by a set of predefined discharge criteria.	determined on discharge from hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	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	Whilst an inpatient
Episodes of hypotension in the postoperative period	This will be defined as a systolic blood pressure of less than 90 mmHg	whilst an inpatient
Postoperative pain	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.	as an inpatient
Amount of postoperative IV fluid administered	This will be documented on each postoperative day.	as an inpatient
Body composition	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.	Tests will be performed daily until the epidural or Painbuster® has been removed.
Postoperative analgesic requirement	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.	As an inpatient
Postoperative stress response	This will be assessed using: SIRS criteria C reactive protein Indirect calorimetry on alternate days at a fixed time.	As an inpatient
Anaesthetic time required	he time taken in minutes for insertion of epidural or wound catheter will be recorded in each group.	On the day of operation
Postoperative mobility	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.	as an inpatient
Day of return of gut function	Return of gut function will be defined by the tolerance of >/= 80% of the prescribed nutritional requirement. This will be assessed by a dietician.	As an inpatient

Collaborators and Investigators

• Sponsor: Scarborough General Hospital
• Investigators: Principal Investigator: Eleanor R Richards, BM Medicine, Scarborough General Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: January 19, 2011
• First Submitted That Met QC Criteria: January 19, 2011
• First Posted (Estimate): January 20, 2011

Study Record Updates

• Last Update Posted (Estimate): February 18, 2011
• Last Update Submitted That Met QC Criteria: February 17, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Epidural; colorectal surgery; ERAS; enhanced recovery program; Local anaesthetic wound catheter; Painbuster
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 10/H1308/63