Pain Management Strategies in Liver Resection SurgeryNCT02192879
TEA vs. PVB vs. PCA in Liver Resection Surgery
A study testing thoracic epidural and continuous paravertebral catheter in people with Pain Management Strategies in Liver Resection Surgery, run by Duke University at 1 site in United States.
Trial summary
This study aims to compare the efficacy and safety of three alternative methods of analgesia in patients undergoing complex liver resection surgery: 1) thoracic epidural analgesia (TEA), 2) continuous paravertebral block (PVB) with patient-controlled analgesia (PCA) and 3) patient-controlled analgesia (PCA) alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain Management Strategies in Liver Resection Surgery
- What is being tested?
- thoracic epidural and continuous paravertebral catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 18 years and </= 80 years
- Scheduled for elective hepatic resection surgery
Who cannot join
- Preexisting coagulopathy (INR >1.5)
- Spinal stenosis
- Local infection in area where catheter will be inserted
- Severe cardiovascular disease (NYHA Class III/IV)
- Severe pulmonary disease (FEV1 <50% of predicted value)
- Allergy or sensitivity to narcotics or local anesthetics
- BMI >45
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Comparison of the Efficacy of Alternative Analgesia Modalities in Complex Hepatic Resection Surgery: Thoracic Epidural Analgesia Versus Continuous Paravertebral Block With Patient-Controlled Analgesia Versus Patient-Controlled Analgesia
This study aims to compare the efficacy and safety of three alternative methods of analgesia in patients undergoing complex liver resection surgery: 1) thoracic epidural analgesia (TEA), 2) continuous paravertebral block (PVB) with patient-controlled analgesia (PCA) and 3) patient-controlled analgesia (PCA) alone. Regional anesthesia techniques such as TEA and PVB may improve recovery and decrease postoperative pain scores in addition to other benefits such earlier return of bowel function and shortened length of hospital stay, although some practitioners have voiced concerns about the safety and efficacy of these techniques in patients after liver resection who may develop postoperative coagulation abnormalities. The investigators plan to enroll a total of 150 patients (adults >/= 18 years of age who meet study criteria) scheduled for complex liver resection surgery in this study, who will then be randomized into 50 patients per arm of the study (3 total arms). Postoperative pain scores will be collected in PACU and throughout the patient's hospital stay as well as routine blood tests including complete blood count, coagulation labs (PT/INR, aPTT) and serum creatinine to measure renal function. The study team will also collect additional data prospectively on all patients enrolled in the study; these parameters will include age, sex, type of operation performed, length of operation, volume of intraoperative blood loss, volume of intraoperative fluid administration including blood products, daily postoperative intravenous fluid administration, length of time to first feeding, day of epidural catheter removal, length of hospital stay and incidence of major postoperative complications (surgical, respiratory, cardiac, renal, etc.). Once primary and secondary data points are obtained, the data will undergo rigorous statistical analysis using the appropriate statistical techniques to determine the outcomes. The investigators propose that epidural and/or paravertebral analgesia may improve recovery times and decrease hospital length of stay, which would be beneficial for the patient as well as decrease hospital costs. In addition, if better postoperative pain management scores can be achieved with epidural or paravertebral analgesia, and no significant prolonged postoperative coagulopathy is associated with patients undergoing major hepatic resection surgical procedures, these regional analgesia strategies can be considered a safe option for pain management in this patient population.
- Being tested
- thoracic epidural, continuous paravertebral catheter, Patient-Controlled Analgesia
- Keywords
- thoracic epidural, continuous paravertebral catheter, PCA, liver resection, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic epiduralDevice
Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
continuous paravertebral catheterDevice
Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
Patient-Controlled AnalgesiaDrug
Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Epidural | Active comparator | Not described Receives: Device: thoracic epidural |
| Continuous Paravertebral Catheter | Active comparator | Not described Receives: Device: continuous paravertebral catheter |
| Patient-Controlled Analgesia | Active comparator | Not described Receives: Drug: Patient-Controlled Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highest VAS Pain Score at Rest
Post-operative pain scores at rest, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be the primary outcome measured. Pain scores will be collected per standard PACU protocol (every 60 minutes) and on the hospital ward at hours 2, 4, 6 and 12, and then daily until day 3 or when the epidural/paravertebral catheter is removed. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).
Measured: postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days
Secondary outcomes (5)
Hospital Length of Stay
Hospital length of stay will be recorded for each of the 3 groups to see if there is a statistical difference between groups.
Measured: time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise
Gastrointestinal Recovery
Postoperative return of bowel function and time to first feeding will be recorded for each of the 3 groups.
Measured: postoperatively until return of bowel function, up to 7 days
Cumulative Postoperative Opioid Requirement
Cumulative postoperative opioid use in morphine equivalents will be recorded for subjects in the 3 arms of the study. The investigators hypothesize that the TEA and/or PVB arms may show less opioid use over PCA.
Measured: postpoperatively until regional catheter removed or subjects transitioned to an oral pain management regimen, an expected average of 3 days and up to 7 days
Incidence of Major Postoperative Complication
Major surgical, infectious, respiratory, cardiac, and renal complications will be recorded for subjects in each arm of the study.
Measured: time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise
Highest VAS Pain Scores With Coughing
Post-operative pain scores with coughing, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be measured. Pain score is from 0 (no hurt) to 10 (hurts worst).
Measured: postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Unable to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain Management Strategies in Liver Resection SurgeryStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth B Malinzak, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192879
- Sponsor's protocol ID
- Pro00042166
- Status last verified
- Sep 2016
- First submitted
- 11 Jul 2014
- Last updated
- 24 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Efficacy of Alternative Analgesia Modalities in Complex Hepatic Resection Surgery: Thoracic Epidural Analgesia Versus Continuous Paravertebral Block With Patient-Controlled Analgesia Versus Patient-Controlled Analgesia
- ClinicalTrials.gov ID
- NCT02192879
- Acronym / sponsor ID
- Pro00042166
- Keywords
- thoracic epidural, continuous paravertebral catheter, PCA, liver resection, pain management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit subjects
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Posted 12 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the efficacy and safety of three alternative methods of analgesia in patients undergoing complex liver resection surgery: 1) thoracic epidural analgesia (TEA), 2) continuous paravertebral block (PVB) with patient-controlled analgesia (PCA) and 3) patient-controlled analgesia (PCA) alone. Regional anesthesia techniques such as TEA and PVB may improve recovery and decrease postoperative pain scores in addition to other benefits such earlier return of bowel function and shortened length of hospital stay, although some practitioners have voiced concerns about the safety and efficacy of these techniques in patients after liver resection who may develop postoperative coagulation abnormalities. The investigators plan to enroll a total of 150 patients (adults >/= 18 years of age who meet study criteria) scheduled for complex liver resection surgery in this study, who will then be randomized into 50 patients per arm of the study (3 total arms). Postoperative pain scores will be collected in PACU and throughout the patient's hospital stay as well as routine blood tests including complete blood count, coagulation labs (PT/INR, aPTT) and serum creatinine to measure renal function. The study team will also collect additional data prospectively on all patients enrolled in the study; these parameters will include age, sex, type of operation performed, length of operation, volume of intraoperative blood loss, volume of intraoperative fluid administration including blood products, daily postoperative intravenous fluid administration, length of time to first feeding, day of epidural catheter removal, length of hospital stay and incidence of major postoperative complications (surgical, respiratory, cardiac, renal, etc.). Once primary and secondary data points are obtained, the data will undergo rigorous statistical analysis using the appropriate statistical techniques to determine the outcomes. The investigators propose that epidural and/or paravertebral analgesia may improve recovery times and decrease hospital length of stay, which would be beneficial for the patient as well as decrease hospital costs. In addition, if better postoperative pain management scores can be achieved with epidural or paravertebral analgesia, and no significant prolonged postoperative coagulopathy is associated with patients undergoing major hepatic resection surgical procedures, these regional analgesia strategies can be considered a safe option for pain management in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thoracic Epidural | Active comparator | Device: thoracic epidural |
| Continuous Paravertebral Catheter | Active comparator | Device: continuous paravertebral catheter |
| Patient-Controlled Analgesia | Active comparator | Drug: Patient-Controlled Analgesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >/= 18 years and </= 80 years
- Scheduled for elective hepatic resection surgery
Key exclusion criteria (8 listed)
- Preexisting coagulopathy (INR >1.5)
- Spinal stenosis
- Local infection in area where catheter will be inserted
- Severe cardiovascular disease (NYHA Class III/IV)
- Severe pulmonary disease (FEV1 <50% of predicted value)
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 |
|---|---|---|
| thoracic epiduralThoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS). | Device | Thoracic Epidural |
| continuous paravertebral catheterBilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed. | Device | Continuous Paravertebral Catheter |
| Patient-Controlled AnalgesiaIntravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team. | Drug | Patient-Controlled Analgesia |
Primary outcome
Highest VAS Pain Score at Rest
Time frame: postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days
Post-operative pain scores at rest, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be the primary outcome measured. Pain scores will be collected per standard PACU protocol (every 60 minutes) and on the hospital ward at hours 2, 4, 6 and 12, and then daily until day 3 or when the epidural/paravertebral catheter is removed. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).
5 secondary outcomes
Hospital Length of Stay
Time frame: time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise
Gastrointestinal Recovery
Time frame: postoperatively until return of bowel function, up to 7 days
Cumulative Postoperative Opioid Requirement
Time frame: postpoperatively until regional catheter removed or subjects transitioned to an oral pain management regimen, an expected average of 3 days and up to 7 days
Incidence of Major Postoperative Complication
Time frame: time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise
Highest VAS Pain Scores With Coughing
Time frame: postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Elizabeth B Malinzak, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracic epidural and continuous paravertebral catheter in people with Pain Management Strategies in Liver Resection Surgery, run by Duke University at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 24 Oct 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 States. 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?
Yes. Results are posted in the registry (first posted 12 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Highest VAS Pain Score at Rest (time frame: postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days). 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 24 Oct 2016.