Open Liver ResectionLIVER 2NCT01747122
The Effects of Local Infiltration Versus Epidural Following Liver Resection 2
A study testing Wound catheter and Epidural in people with Open Liver Resection, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
The investigators plan to compare epidurals versus wound catheters for effects on pain relief and recovery following open liver surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Liver Resection
- What is being tested?
- Wound catheter and Epidural
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2012to Aug 2014
- 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
- Patients undergoing open hepatic resection for benign or malignant conditions.
Who cannot join
- Patients with contraindication to either epidural or wound catheter techniques.
- Inability to give written, informed consent.
- Jaundice (Bilirubin > 100 μmol/L)
- Liver resection combined with secondary surgical procedure.
- Age < 18 years
- Pregnant women
- patients on long term opiates for chronic pain
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA
About this study
Official title: A Randomised Trial of Peri-operative Nerve Block and Continuous Infusion of Local Anaesthetic Via Wound Catheter Versus Epidural in Patients Undergoing Open Liver Resection.
The investigators plan to compare epidurals versus wound catheters for effects on pain relief and recovery following open liver surgery.
- Conditions
- Open Liver Resection
- Being tested
- Wound catheter, Epidural
- Keywords
- epidurals, wound catheters, liver resection, liver surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound catheterDevice
Also called On-Q Painbuster
Wound catheter, placed at end of procedure, prior to closure. To be kept in for 48 hours.
EpiduralDevice
| Study group | Role | What they receive |
|---|---|---|
| Wound catheter | Experimental | Wound catheter Receives: Device: Wound catheter |
| Epidural | Active comparator | Standard epidural, pre-operative insertion, to be run for 48 hours Receives: Device: Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Number of days (to nearest half day) patients stay in hospital.
Measured: Measurement made on day of discharge which is expected to be on average bewteen 5 and 10 days after surgery.
Secondary outcomes (6)
Pain Scores
Visual analogue scores of pain experienced.
Measured: Performed daily at 0900 hours. On the day of surgery pain scores will be performed at 2, 6 and 12 hours post surgery.
Molecular response to surgery
HMGB1, RAGE and cytokines
Measured: Days 0, 1 and 3
Central Venous Pressure
Mean Central Venous Pressure during liver transection will be quantified and compared between groups.
Measured: During liver transection
Estimated Blood Loss
Measured: Intra-operative
Operative field asessment
Measured: During liver transection
Pringle time
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Open Liver ResectionStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Michael J Hughes, MBChB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747122
- Sponsor's protocol ID
- 2012/R/SU/01 - LIVER 2 Trial
- Acronym
- LIVER 2
- Status last verified
- Oct 2014
- First submitted
- 28 Nov 2012
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Revie EJ, McKeown DW, Wilson JA, Garden OJ, Wigmore SJ. Randomized clinical trial of local infiltration plus patient-controlled opiate analgesia vs. epidural analgesia following liver resection surgery. HPB (Oxford). 2012 Sep;14(9):611-8. doi: 10.1111/j.1477-2574.2012.00490.x. Epub 2012 Jun 10.
PubMed 22882198Hughes MJ, Harrison EM, Peel NJ, Stutchfield B, McNally S, Beattie C, Wigmore SJ. Randomized clinical trial of perioperative nerve block and continuous local anaesthetic infiltration via wound catheter versus epidural analgesia in open liver resection (LIVER 2 trial). Br J Surg. 2015 Dec;102(13):1619-28. doi: 10.1002/bjs.9949. Epub 2015 Oct 8.
PubMed 26447461
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial of Peri-operative Nerve Block and Continuous Infusion of Local Anaesthetic Via Wound Catheter Versus Epidural in Patients Undergoing Open Liver Resection.
- ClinicalTrials.gov ID
- NCT01747122
- Acronym / sponsor ID
- LIVER 2 / 2012/R/SU/01 - LIVER 2 Trial
- Conditions
- Open Liver Resection
- Keywords
- epidurals, wound catheters, liver resection, liver surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- Dec 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Dec 2012 (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 investigators plan to compare epidurals versus wound catheters for effects on pain relief and recovery following open liver surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wound catheter | Experimental | Device: Wound catheterWound catheter |
| Epidural | Active comparator | Device: EpiduralStandard epidural, pre-operative insertion, to be run for 48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing open hepatic resection for benign or malignant conditions.
Key exclusion criteria (7 listed)
- Patients with contraindication to either epidural or wound catheter techniques.
- Inability to give written, informed consent.
- Jaundice (Bilirubin > 100 μmol/L)
- Liver resection combined with secondary surgical procedure.
- Age < 18 years
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 |
|---|---|---|
| Wound catheterAlso: On-Q PainbusterWound catheter, placed at end of procedure, prior to closure. To be kept in for 48 hours. | Device | Wound catheter |
| Epidural | Device | Epidural |
Primary outcome
Length of stay
Time frame: Measurement made on day of discharge which is expected to be on average bewteen 5 and 10 days after surgery.
Number of days (to nearest half day) patients stay in hospital.
6 secondary outcomes
Pain Scores
Time frame: Performed daily at 0900 hours. On the day of surgery pain scores will be performed at 2, 6 and 12 hours post surgery.
Molecular response to surgery
Time frame: Days 0, 1 and 3
Central Venous Pressure
Time frame: During liver transection
Estimated Blood Loss
Time frame: Intra-operative
Operative field asessment
Time frame: During liver transection
Pringle time
Time frame: Intra-operative
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 15 Oct 2014.
- Background: PubMed 22882198Revie EJ, McKeown DW, Wilson JA, Garden OJ, Wigmore SJ. Randomized clinical trial of local infiltration plus patient-controlled opiate analgesia vs. epidural analgesia following liver resection surgery. HPB (Oxford). 2012 Sep;14(9):611-8. doi: 10.1111/j.1477-2574.2012.00490.x. Epub 2012 Jun 10.
- Derived from this study: PubMed 26447461Hughes MJ, Harrison EM, Peel NJ, Stutchfield B, McNally S, Beattie C, Wigmore SJ. Randomized clinical trial of perioperative nerve block and continuous local anaesthetic infiltration via wound catheter versus epidural analgesia in open liver resection (LIVER 2 trial). Br J Surg. 2015 Dec;102(13):1619-28. doi: 10.1002/bjs.9949. Epub 2015 Oct 8.
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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.
Michael J Hughes, MBChB principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound catheter and Epidural in people with Open Liver Resection, run by University of Edinburgh 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 15 Oct 2014. 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?
Length of stay (time frame: Measurement made on day of discharge which is expected to be on average bewteen 5 and 10 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01747122, which also lists 2 linked publications.
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 15 Oct 2014.