Colorectal CancerPROSPNCT02210260
Pain Relief After Colorectal Surgery: Spinal Combined With Painbuster® vs Painbuster® Alone.
A study testing Spinal and infusion of local anaesthetic, Continuous infusion of local anaesthetic and Bupivacaine in people with Colorectal Cancer, run by York Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Limiting surgical stress and managing postoperative pain are well understood to influence recovery and outcome from major surgery for colorectal cancer and both are fundamental aspects of enhanced recovery protocols. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Spinal and infusion of local anaesthetic, Continuous infusion of local anaesthetic and Bupivacaine
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Feb 2016
- 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 resections will be considered eligible for the study.
Who cannot join
- Patients under 18 years of age.
- Pregnant females.
- Patients undergoing an abdominoperineal resection.
- Patients who will not contemplate being randomized to receive a spinal anaesthetic.
- Patients with a history of failure to place an epidural / spinal anaesthetic.
- Hypersensitivity to local anaesthetics.
- Lack of capacity to give consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Scarborough General Hospital
Scarborough, North Yorkshire, YO12 6QL
About this study
Official title: Pain Relief After Colorectal Surgery: Single-shot Spinal Combined With Painbuster® vs Painbuster® Alone. A Pilot Randomised Controlled Trial
Limiting surgical stress and managing postoperative pain are well understood to influence recovery and outcome from major surgery for colorectal cancer and both are fundamental aspects of enhanced recovery protocols.
Traditional approaches for dealing with these problems such as epidural or patient controlled intravenous opioid analgesia are associated with problems that may be detrimental to postoperative recovery and surgical outcome. As a result there is evidence in the literature of increasing interest in alternative techniques such as intrathecal anaesthesia or continuous wound infusion of local anaesthetic, however nobody has examined the effect of combining the techniques or their impact on the surgical stress response.
Read more
We intend to compare patients undergoing major resections for colorectal cancer receiving intrathecal anaesthesia in combination with a wound infusion of local anaesthetic with those receiving a continuous wound infusion alone. We will examine the surgical stress response and postoperative pain control in addition to objective measures of postoperative recovery.
We suggest that our approach will attenuate the surgical stress response and provide optimal pain control that will ultimately translate in improved recovery and outcome following surgery for colorectal cancer.
Read the detailed description
This is a pilot randomised controlled trial
Hypotheses -
Following colorectal surgery, spinal anaesthesia combined with a continuous infusion of local anaesthetic into the surgical wound provides
- better pain relief
- a reduced stress response when compared to the use of continuous infusion of local anaesthetic into the surgical wound alone.
Patients undergoing surgical resection for colorectal cancer will be randomised to receive either
- A single shot of spinal anaesthesia plus a continuous infusion of local anaesthetic into the surgical wound or
- Continuous infusion of local anaesthetic into the surgical wound
Spinal Anaesthesia
The spinal anaesthetic (SA) with be placed after commencement of general anaesthesia this will ensure the patients remain blinded to the intervention. SA will be performed in the lateral position using a midline approach. L3/4 interspace will be identified using Tuffier's as the anatomical landmark. After confirmation of correct placement using a 25G Whitacre needle, 12.5 mg of hyperbaric Bupivacaine in a mixture with 500mcg Diamorphine will be injected intrathecally.
Infusion of local anaesthetic
The catheter through which the infusion of local anaesthetic will be given, will be placed by the surgeon at the end of the procedure in a location determined by the surgical approach. A bolus dose of 20ml 0.25% L-Bupivacaine will be injected down the catheters prior to the connection of the elastomeric pump which will also contain 270ml 0.25% L-Bupivacaine
General anaesthesia will be managed in the same way for both groups
- Conditions
- Colorectal Cancer
- Being tested
- Spinal and infusion of local anaesthetic, Continuous infusion of local anaesthetic, Bupivacaine, Diamorphine, A Painbuster® catheter
- Keywords
- Cancer, Colorectal, Pain relief
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal and infusion of local anaestheticProcedure or surgery
Spinal anaesthetic will be performed in the lateral position using a midline approach. L3/4 interspace will be identified using Tuffier's as the anatomical landmark. After confirmation of correct placement using a 25G Whitacre needle, 12.5 mg of hyperbaric Bupivacaine in a mixture with 500mcg Diamorphine will be injected intrathecally.
PLUS
Painbuster® catheters will be placed by the surgeon at the end of the procedure in a location determined by the surgical approach. A bolus dose of 20ml 0.25% L-Bupivacaine will be injected down the catheters prior to the connection of the elastomeric pump which will also contain 270ml 0.25% L-Bupivacaine.
Continuous infusion of local anaestheticProcedure or surgery
A Painbuster® catheter will be placed by the surgeon at the end of the procedure in a location determined by the surgical approach. A bolus dose of 20ml 0.25% L-Bupivacaine will be injected down the catheters prior to the connection of the elastomeric pump which will also contain 270ml 0.25% L-Bupivacaine.
BupivacaineDrug
DiamorphineDrug
500mcg
A Painbuster® catheterDevice
25G Whitacre needleDevice
| Study group | Role | What they receive |
|---|---|---|
| Continuous infusion of local anaesthetic | Active comparator | Continuous infusion of local anaesthetic into the surgical wound Receives: Procedure: Continuous infusion of local anaesthetic; Drug: Bupivacaine; Device: A Painbuster® catheter |
| Spinal and infusion of local anaesthetic | Experimental | A one off spinal anaesthetic plus a continuous infusion of local anaesthetic into the surgical wound Receives: Procedure: Spinal and infusion of local anaesthetic; Drug: Bupivacaine; Drug: Diamorphine; Device: A Painbuster® catheter; Device: 25G Whitacre needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroendocrine response to surgery
Peripheral blood samples taken at baseline, 60 minutes after surgical incision and 24 hours postoperatively will be analysed for cortisol and noradrenaline.
Measured: 24 hours
Secondary outcomes (10)
Length of hospital stay or fitness for discharge
Discharge criteria:
- Good pain control with oral analgesia.
- Tolerating solid food without nausea and vomiting.
- No IV fluid or medication.
- Independently mobile and self-caring or at the same level as prior to admission.
- Stable observations and blood biochemistry.
- No other concerns or complications preventing discharge.
Measured: Up to 12 days
Postoperative complications
All complications in the postoperative period will be recorded. Particular emphasis will be given to:
Wound infection
Cardiac failure:
Complications related to spinal anaesthesia.
Adequacy of deep vein thrombosis prophylaxis.
Measured: Up to 12 days
Episodes of hypotension in the postoperative period
This will be defined as a sustained systolic blood pressure of less than 90 mm/Hg.
Measured: Up to 12 days
Postoperative pain
This will be assessed using a visual analogue scale . Measurements will be taken in recovery then once a day for 72 hours postoperatively. Pain scores will be measured at rest and on coughing.
Measured: Up to 72 hours after surgery
Postoperative analgesic requirement
The total quantity and type (opiate or non-opiate) of all analgesics administered for 72 hours postoperatively.
Measured: Up to 72 hours after surgery
Amount of postoperative IV fluid administered
Total amount of IV fluid given in postoperative period
Measured: Up to 12 days
Postoperative mobility
Postoperative mobility will be assessed as
time until able to stand aided and unaided,
duration of time spent out of bed on each postoperative day
maximum walking distance with assistance on a daily basis.
Measured: Up to 12 days
Return of gut function
4.2.8 Time to return of gut function This is defined by the oral/enteral tolerance of > 80% of nutritional requirement.
These requirements will be assessed individually for each patient in the study by an appropriately trained dietician
Measured: Up to 12 days
Oxidative stress
Peripheral blood samples will be taken at baseline, 60 minutes after surgical incision and 24 hours postoperatively and analysed for heat shock proteins 37 and 32.
Measured: For 24 hours
Inflammatory pathway
Peripheral blood samples taken at baseline, 60 minutes after surgical incision and 24 hours postoperatively will be analysed for IL1.
Peritoneal biopsies taken prior to closure of surgical wound and analysed for IL1.
Measured: Up to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- York Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Harper, MBChB, FRCA, Principal investigator, York Teaching Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210260
- Sponsor's protocol ID
- SNE 2190
- Acronym
- PROSP
- Status last verified
- Sep 2016
- First submitted
- 31 Jul 2014
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief After Colorectal Surgery: Single-shot Spinal Combined With Painbuster® vs Painbuster® Alone. A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02210260
- Acronym / sponsor ID
- PROSP / SNE 2190
- Conditions
- Colorectal Cancer
- Keywords
- Cancer, Colorectal, Pain relief
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- York Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 6 Aug 2014 (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.
Limiting surgical stress and managing postoperative pain are well understood to influence recovery and outcome from major surgery for colorectal cancer and both are fundamental aspects of enhanced recovery protocols.
Traditional approaches for dealing with these problems such as epidural or patient controlled intravenous opioid analgesia are associated with problems that may be detrimental to postoperative recovery and surgical outcome. As a result there is evidence in the literature of increasing interest in alternative techniques such as intrathecal anaesthesia or continuous wound infusion of local anaesthetic, however nobody has examined the effect of combining the techniques or their impact on the surgical stress response.
We intend to compare patients undergoing major resections for colorectal cancer receiving intrathecal anaesthesia in combination with a wound infusion of local anaesthetic with those receiving a continuous wound infusion alone. We will examine the surgical stress response and postoperative pain control in addition to objective measures of postoperative recovery.
We suggest that our approach will attenuate the surgical stress response and provide optimal pain control that will ultimately translate in improved recovery and outcome following surgery for colorectal cancer.
Detailed description
This is a pilot randomised controlled trial
Hypotheses -
Following colorectal surgery, spinal anaesthesia combined with a continuous infusion of local anaesthetic into the surgical wound provides
- better pain relief
- a reduced stress response when compared to the use of continuous infusion of local anaesthetic into the surgical wound alone.
Patients undergoing surgical resection for colorectal cancer will be randomised to receive either
- A single shot of spinal anaesthesia plus a continuous infusion of local anaesthetic into the surgical wound or
- Continuous infusion of local anaesthetic into the surgical wound
Spinal Anaesthesia
The spinal anaesthetic (SA) with be placed after commencement of general anaesthesia this will ensure the patients remain blinded to the intervention. SA will be performed in the lateral position using a midline approach. L3/4 interspace will be identified using Tuffier's as the anatomical landmark. After confirmation of correct placement using a 25G Whitacre needle, 12.5 mg of hyperbaric Bupivacaine in a mixture with 500mcg Diamorphine will be injected intrathecally.
Infusion of local anaesthetic
The catheter through which the infusion of local anaesthetic will be given, will be placed by the surgeon at the end of the procedure in a location determined by the surgical approach. A bolus dose of 20ml 0.25% L-Bupivacaine will be injected down the catheters prior to the connection of the elastomeric pump which will also contain 270ml 0.25% L-Bupivacaine
General anaesthesia will be managed in the same way for both groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion of local anaesthetic | Active comparator | Procedure: Continuous infusion of local anaesthetic, Drug: Bupivacaine, Device: A Painbuster® catheterContinuous infusion of local anaesthetic into the surgical wound |
| Spinal and infusion of local anaesthetic | Experimental | Procedure: Spinal and infusion of local anaesthetic, Drug: Bupivacaine, Drug: Diamorphine, Device: A Painbuster® catheter, Device: 25G Whitacre needleA one off spinal anaesthetic plus a continuous infusion of local anaesthetic into the surgical wound |
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 resections will be considered eligible for the study.
Key exclusion criteria (7 listed)
- Patients under 18 years of age.
- Pregnant females.
- Patients undergoing an abdominoperineal resection.
- Patients who will not contemplate being randomized to receive a spinal anaesthetic.
- Patients with a history of failure to place an epidural / spinal anaesthetic.
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 |
|---|---|---|
| Spinal and infusion of local anaestheticSpinal anaesthetic will be performed in the lateral position using a midline approach. L3/4 interspace will be identified using Tuffier's as the anatomical landmark. After confirmation of correct placement using a 25G Whitacre needle, 12.5 mg of hyperbaric Bupivacaine in a mixture with 500mcg Diamorphine will be injected intrathecally. PLUS Painbuster® catheters will be placed by the surgeon at the end of the procedure in a location determined by the surgical approach. A bolus dose of 20ml 0.25% L-Bupivacaine will be injected down the catheters prior to the connection of the elastomeric pump which will also contain 270ml 0.25% L-Bupivacaine. | Procedure or surgery | Spinal and infusion of local anaesthetic |
| Continuous infusion of local anaestheticA Painbuster® catheter will be placed by the surgeon at the end of the procedure in a location determined by the surgical approach. A bolus dose of 20ml 0.25% L-Bupivacaine will be injected down the catheters prior to the connection of the elastomeric pump which will also contain 270ml 0.25% L-Bupivacaine. | Procedure or surgery | Continuous infusion of local anaesthetic |
| Bupivacaine | Drug | Continuous infusion of local anaesthetic, Spinal and infusion of local anaesthetic |
| Diamorphine500mcg | Drug | Spinal and infusion of local anaesthetic |
| A Painbuster® catheter | Device | Continuous infusion of local anaesthetic, Spinal and infusion of local anaesthetic |
| 25G Whitacre needle | Device | Spinal and infusion of local anaesthetic |
Primary outcome
Neuroendocrine response to surgery
Time frame: 24 hours
Peripheral blood samples taken at baseline, 60 minutes after surgical incision and 24 hours postoperatively will be analysed for cortisol and noradrenaline.
10 secondary outcomes
Length of hospital stay or fitness for discharge
Time frame: Up to 12 days
Postoperative complications
Time frame: Up to 12 days
Episodes of hypotension in the postoperative period
Time frame: Up to 12 days
Postoperative pain
Time frame: Up to 72 hours after surgery
Postoperative analgesic requirement
Time frame: Up to 72 hours after surgery
Amount of postoperative IV fluid administered
Time frame: Up to 12 days
Postoperative mobility
Time frame: Up to 12 days
Return of gut function
Time frame: Up to 12 days
Oxidative stress
Time frame: For 24 hours
Inflammatory pathway
Time frame: Up to 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
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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.
Daniel Harper, MBChB, FRCA principal investigator
York Teaching Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal and infusion of local anaesthetic, Continuous infusion of local anaesthetic and Bupivacaine in people with Colorectal Cancer, run by York Teaching Hospitals NHS Foundation Trust 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 7 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: finished, as of the sponsor's last update on 14 Sep 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroendocrine response to surgery (time frame: 24 hours). 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 14 Sep 2016.