Transplant SurgeryNCT03638401
Epidural vs. Wound Catheter Following Liver Resection
A study testing This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA. in people with Transplant Surgery, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Good postoperative pain control after any major surgery allows early mobilization, minimises postoperative complications and reduces patient distress. Multiple different methods of delivering analgesia have been described. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Transplant Surgery
- What is being tested?
- This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2014to 5 Oct 2015
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients scheduled to undergo an open liver resection at this hospital will be eligible to participate.
Who cannot join
- Patients with a contraindication to either epidural or wound catheter
- Inability to give written, informed consent
- Aged less than 18 years old
- Liver resection combined with a secondary surgical procedure
- Body mass index of <18 or >40
- Pregnancy or lactation
- A history of chronic pain requiring regular opioid analgesia
- Prisoners
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3HE,
About this study
Good postoperative pain control after any major surgery allows early mobilization, minimises postoperative complications and reduces patient distress. Multiple different methods of delivering analgesia have been described.
This study aims to compare postoperative pain control between patients with epidural analgesia versus the combination of continuous infiltration of local anaesthetic with wound catheters, TAP block and IV PCA with opiate analgesia following open liver resection. The investigators expect that pain control will be similar between the two groups but that the utilization of wound catheters will confer benefit due to the lack of systemic side effects associated with epidural analgesia
- Conditions
- Transplant Surgery
- Being tested
- This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA.Procedure or surgery
This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | No intervention | Not described |
| Intervention arm | Active comparator | Not described Receives: Procedure: This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of hospital stay following open liver resection
Measured: 6 months (or length of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start3 Mar 2014
- Primary completion5 Oct 2015
- Study completion5 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant SurgeryStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638401
- Sponsor's protocol ID
- RL14/11048
- Status last verified
- Aug 2018
- First submitted
- 18 May 2015
- Last updated
- 20 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural vs. Wound Catheter Following Liver Resection
- ClinicalTrials.gov ID
- NCT03638401
- Acronym / sponsor ID
- RL14/11048
- Conditions
- Transplant Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 3 Mar 2014 (actual)
- Primary completion
- 5 Oct 2015 (actual)
- Study completion
- 5 Oct 2015 (actual)
- First posted
- 20 Aug 2018 (actual)
- 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.
Good postoperative pain control after any major surgery allows early mobilization, minimises postoperative complications and reduces patient distress. Multiple different methods of delivering analgesia have been described.
This study aims to compare postoperative pain control between patients with epidural analgesia versus the combination of continuous infiltration of local anaesthetic with wound catheters, TAP block and IV PCA with opiate analgesia following open liver resection. The investigators expect that pain control will be similar between the two groups but that the utilization of wound catheters will confer benefit due to the lack of systemic side effects associated with epidural analgesia
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | No intervention | – |
| Intervention arm | Active comparator | Procedure: This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients scheduled to undergo an open liver resection at this hospital will be eligible to participate.
Key exclusion criteria (8 listed)
- Patients with a contraindication to either epidural or wound catheter
- Inability to give written, informed consent
- Aged less than 18 years old
- Liver resection combined with a secondary surgical procedure
- Body mass index of <18 or >40
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 |
|---|---|---|
| This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA.This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA. | Procedure or surgery | Intervention arm |
Primary outcome
The length of hospital stay following open liver resection
Time frame: 6 months (or length of the study)
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 20 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA. in people with Transplant Surgery, run by The Leeds Teaching Hospitals NHS 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 8 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 20 Aug 2018. 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?
The length of hospital stay following open liver resection (time frame: 6 months (or length of the study)). 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 20 Aug 2018.