PainNCT01279980
Clinical Trial Comparing Epidurals and Local Anaesthetic Wound Catheters in Patients Having Bowel Surgery
A study testing Epidural and Local anaesthetic wound catheter in people with Pain, run by Scarborough General Hospital at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Epidural and Local anaesthetic wound catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who are undergoing either laparoscopic or open colorectal resection will be considered eligible for the study.
Who cannot join
- Patients under 18 years of age
- Pregnant females
- Patients undergoing an abdominoperineal resection
- Patients unable to understand English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Scarborough General Hospital
Scarborough, North Yorkshire, YO126QL
Mark Andrews, (Medical director), 00441723368111, Mark.Andrews@acute.sney.nhs.uk
Eleanor R Richards, BM Medicine
About this study
Official title: 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.
- Conditions
- Pain
- Being tested
- Epidural, Local anaesthetic wound catheter
- Keywords
- ERAS, Local anaesthetic wound catheter, Painbuster, Epidural, colorectal surgery, enhanced recovery program
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiduralOther
Epidural analgesia inserted prior to surgery to stay in until at least the second postoperative day
Local anaesthetic wound catheterOther
Also called Painbuster(registered trademark)
The catheter will be used to infuse the wound with local anaesthetic for 48 hours post op.
| Study group | Role | What they receive |
|---|---|---|
| Epidural | Active comparator | Subjects will have an epidural catheter placed to provide postoperative pain relief. This is standard care for those undergoing an enhanced recovery program. Receives: Other: Epidural |
| Painbuster | Active comparator | 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. Receives: Other: Local anaesthetic wound catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: determined on discharge from hospital
Secondary outcomes (10)
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
Measured: Whilst an inpatient
Episodes of hypotension in the postoperative period
This will be defined as a systolic blood pressure of less than 90 mmHg
Measured: 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.
Measured: as an inpatient
Amount of postoperative IV fluid administered
This will be documented on each postoperative day.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: As an inpatient
Anaesthetic time required
he time taken in minutes for insertion of epidural or wound catheter will be recorded in each group.
Measured: 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.
Measured: 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.
Measured: As an inpatient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scarborough General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Eleanor R Richards, BM Medicine, Principal investigator, Scarborough General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279980
- Sponsor's protocol ID
- 10/H1308/63
- Status last verified
- Feb 2011
- First submitted
- 19 Jan 2011
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Wound Infiltration With Local Anaesthetic vs. Epidurals in an Enhanced Recovery Protocol: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01279980
- Acronym / sponsor ID
- 10/H1308/63
- Conditions
- Pain
- Keywords
- ERAS, Local anaesthetic wound catheter, Painbuster, Epidural, colorectal surgery, enhanced recovery program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Scarborough General HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 20 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural | Active comparator | Other: EpiduralSubjects will have an epidural catheter placed to provide postoperative pain relief. This is standard care for those undergoing an enhanced recovery program. |
| Painbuster | Active comparator | Other: Local anaesthetic wound catheterSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who are undergoing either laparoscopic or open colorectal resection will be considered eligible for the study.
Key exclusion criteria (4 listed)
- Patients under 18 years of age
- Pregnant females
- Patients undergoing an abdominoperineal resection
- Patients unable to understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpiduralEpidural analgesia inserted prior to surgery to stay in until at least the second postoperative day | Other | Epidural |
| Local anaesthetic wound catheterAlso: Painbuster(registered trademark)The catheter will be used to infuse the wound with local anaesthetic for 48 hours post op. | Other | Painbuster |
Primary outcome
Length of hospital stay
Time frame: 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.
10 secondary outcomes
Postoperative complications
Time frame: Whilst an inpatient
Episodes of hypotension in the postoperative period
Time frame: whilst an inpatient
Postoperative pain
Time frame: as an inpatient
Amount of postoperative IV fluid administered
Time frame: as an inpatient
Body composition
Time frame: Tests will be performed daily until the epidural or Painbuster® has been removed.
Postoperative analgesic requirement
Time frame: As an inpatient
Postoperative stress response
Time frame: As an inpatient
Anaesthetic time required
Time frame: On the day of operation
Postoperative mobility
Time frame: as an inpatient
Day of return of gut function
Time frame: As an inpatient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleanor R Richards, BM Medicine principal investigator
Scarborough General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural and Local anaesthetic wound catheter in people with Pain, run by Scarborough General Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleanor R Richards, BM Medicine (0044723368111 ext. 5324, errichards@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: determined on discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2011.