Esophageal CancerNCT03570996
A Trial Comparing Transversus Abdominis Plane Catheter Versus Epidural After Esophagectomy
A study testing Esophagectomy, Transversus abdominis plane catheter and Epidural in people with Esophageal Cancer and Pain, Postoperative, run by Swedish Medical Center at 1 site in United States.
Trial summary
A randomized trial comparing perioperative outcomes between bilateral transversus abdominis plane TAP catheters with patient controlled analgesia (PCA) to epidural for esophagectomy patients with a VATS chest approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Pain, Postoperative
- What is being tested?
- Esophagectomy, Transversus abdominis plane catheter and Epidural
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 1 Mar 2020
- 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 adult individuals who undergo an esophagectomy with a minimally invasive approach of the chest at Swedish Medical Center-First Hill. These approaches include:
- 3 hole with R video-assisted thoracoscopic surgery (VATS)
- Ivor Lewis R VATS
- Transhiatal
Who cannot join
- Age <18
- Unable to consent
- Additional surgical procedures planned
- Patient with chronic pain on a daily regimen of narcotics
- Patients who remain intubated greater than 24 hours post operatively
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Transversus Abdominis Plane Catheter Versus Epidural After Esophagectomy
A randomized trial comparing perioperative outcomes between bilateral transversus abdominis plane TAP catheters with patient controlled analgesia (PCA) to epidural for esophagectomy patients with a VATS chest approach. Further objectives are to determine pain requirements between multiple modalities of pain control and compare the subsequent sequelae of narcotic use and blood pressure control and to compare complications such as anastomotic leak, atrial fibrillation and perioperative morbidity and mortality between the two groups.
Read the detailed description
Epidural analgesia is considered the 'gold standard' for post-operative analgesia following open esophagectomy. Epidurals have been shown to reduce post-operative pulmonary morbidity and mortality. However, epidurals are often associated with sympathetic blockade that creates hypotension and could therefore adversely affect the conduit. Pain management techniques that use peripheral nerve blockade are becoming more prevalent, reducing the need for an epidural. Transversus abdominis plane (TAP) catheters have been used in colorectal and abdominal surgery showing equivocal pain scores to epidurals. With the minimally invasive chest approach, the analgesia coverage focuses on the abdominal incision where both epidurals and TAPs are considered standard of care.
The investigators have completed a retrospective study in preparation for a randomized control trial. The investigators previous retrospective study found that TAP blocks/catheters are a reasonable alternative to epidurals, providing adequate pain coverage for abdominal incisions. The study found no statistical difference in pain scores between the two groups. The TAP group had a lower prevalence of hypotension and lower crystalloid resuscitation needs. Pulmonary complications were similar between the two groups. This retrospective review showed that TAP blocks are a reasonable alternative to epidurals and may reduce episodes of hypotension. The investigators aim is to now expand this study to a randomized control trial.
- Conditions
- Esophageal Cancer, Pain, Postoperative
- Being tested
- Esophagectomy, Transversus abdominis plane catheter, Epidural
- Keywords
- esophageal cancer, transversus abdominis plane catheter, epidural, pain, postoperative
- Medical subject headings
- Esophageal Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagectomyProcedure or surgery
Esophagectomy with minimally invasive approach of the chest including:
3 hole with R video-assisted thoracoscopic surgery (VATS), Ivor Lewis R VATS, Transhiatal
Transversus abdominis plane catheterProcedure or surgery
Also called TAP catheter
TAP group will have bilateral subcostal TAP catheters and single shot bilateral rectus sheath blocks placed at the end of the surgery, prior to emergence. Bilateral subcostal TAP catheters will be bolused with 20ml of .2% ropivacaine on each side and then infused with .2% ropivacaine at 10ml/ hr for 75 hours each. Rectus sheath blocks will be bilateral bolus 20ml of .2% ropivacaine
EpiduralProcedure or surgery
Also called TEP
Patients randomize the TEP group will have bilateral TEP placed at T8-9 +/- one level based on patient anatomy. TEP will be bolused with 5ml of 1.5% lidocaine with epinephrine and then started on infusion of .0625% bupivacaine plus 4 mcg/ml fentanyl plus 2 mcg/ ml epinephrine at 6ml/hr with a range of 6-12 ml/hr, titrating to optimize patient comfort. Epidurals are placed before surgery start time.
| Study group | Role | What they receive |
|---|---|---|
| Transversus abdominis plane catheter | Active comparator | Transversus abdominis plane catheter (TAP) for pain control in esophagectomy operations. TAP group will have bilateral subcostal TAP catheters and single shot bilateral rectus sheath blocks placed at the end of the surgery, prior to emergence. Bilateral subcostal TAP catheters will be bolused with 20ml of .2% ropivacaine on each side and then infused with .2% ropivacaine at 10ml/ hr for 75 hours each. Rectus sheath blocks will be bilateral bolus 20ml of .2% ropivacaine. Receives: Procedure: Esophagectomy; Procedure: Transversus abdominis plane catheter |
| epidural | Active comparator | Epidural pain control for pain control in esophagectomy operation. Patients randomize the TEP group will have bilateral TEP placed at T8-9 +/- one level based on patient anatomy. TEP will be bolused with 5ml of 1.5% lidocaine with epinephrine and then started on infusion of .0625% bupivacaine plus 4 mcg/ml fentanyl plus 2 mcg/ ml epinephrine at 6ml/hr with a range of 6-12 ml/hr, titrating to optimize patient comfort. Epidurals are placed before surgery start time. Receives: Procedure: Esophagectomy; Procedure: Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Pain scores on a scale of 0-10 will be collected from patients twice a day
Measured: Up to post-operative day 4
Secondary outcomes (2)
Volume Resuscitation
Amount of fluids given to patient
Measured: Up to post-operative day 4
Hypotension
Total episodes of hypotension
Measured: Up to post-operative day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start1 Jan 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it stopped: COVID 19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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
- Sequential
- Model description
- Randomization into either transversus abdominis plane catheter (TAP) or epidural for patients undergoing esophagectomy
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian E Louie, MD, Principal investigator, Swedish Cancer Institute and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570996
- Sponsor's protocol ID
- STUDY2017000592
- Status last verified
- Jan 2023
- First submitted
- 21 Mar 2018
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Transversus Abdominis Plane Catheter Versus Epidural After Esophagectomy
- ClinicalTrials.gov ID
- NCT03570996
- Acronym / sponsor ID
- STUDY2017000592
- Conditions
- Esophageal Cancer, Pain, Postoperative
- Keywords
- esophageal cancer, transversus abdominis plane catheter, epidural, pain, postoperative
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID 19
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 27 Jun 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.
A randomized trial comparing perioperative outcomes between bilateral transversus abdominis plane TAP catheters with patient controlled analgesia (PCA) to epidural for esophagectomy patients with a VATS chest approach. Further objectives are to determine pain requirements between multiple modalities of pain control and compare the subsequent sequelae of narcotic use and blood pressure control and to compare complications such as anastomotic leak, atrial fibrillation and perioperative morbidity and mortality between the two groups.
Detailed description
Epidural analgesia is considered the 'gold standard' for post-operative analgesia following open esophagectomy. Epidurals have been shown to reduce post-operative pulmonary morbidity and mortality. However, epidurals are often associated with sympathetic blockade that creates hypotension and could therefore adversely affect the conduit. Pain management techniques that use peripheral nerve blockade are becoming more prevalent, reducing the need for an epidural. Transversus abdominis plane (TAP) catheters have been used in colorectal and abdominal surgery showing equivocal pain scores to epidurals. With the minimally invasive chest approach, the analgesia coverage focuses on the abdominal incision where both epidurals and TAPs are considered standard of care.
The investigators have completed a retrospective study in preparation for a randomized control trial. The investigators previous retrospective study found that TAP blocks/catheters are a reasonable alternative to epidurals, providing adequate pain coverage for abdominal incisions. The study found no statistical difference in pain scores between the two groups. The TAP group had a lower prevalence of hypotension and lower crystalloid resuscitation needs. Pulmonary complications were similar between the two groups. This retrospective review showed that TAP blocks are a reasonable alternative to epidurals and may reduce episodes of hypotension. The investigators aim is to now expand this study to a randomized control trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization into either transversus abdominis plane catheter (TAP) or epidural for patients undergoing esophagectomy
| Arm | Type | Receives |
|---|---|---|
| Transversus abdominis plane catheter | Active comparator | Procedure: Esophagectomy, Procedure: Transversus abdominis plane catheterTransversus abdominis plane catheter (TAP) for pain control in esophagectomy operations. TAP group will have bilateral subcostal TAP catheters and single shot bilateral rectus sheath blocks placed at the end of the surgery, prior to emergence. Bilateral subcostal TAP catheters will be bolused with 20ml of .2% ropivacaine on each side and then infused with .2% ropivacaine at 10ml/ hr for 75 hours each. Rectus sheath blocks will be bilateral bolus 20ml of .2% ropivacaine. |
| epidural | Active comparator | Procedure: Esophagectomy, Procedure: EpiduralEpidural pain control for pain control in esophagectomy operation. Patients randomize the TEP group will have bilateral TEP placed at T8-9 +/- one level based on patient anatomy. TEP will be bolused with 5ml of 1.5% lidocaine with epinephrine and then started on infusion of .0625% bupivacaine plus 4 mcg/ml fentanyl plus 2 mcg/ ml epinephrine at 6ml/hr with a range of 6-12 ml/hr, titrating to optimize patient comfort. Epidurals are placed before surgery start time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All adult individuals who undergo an esophagectomy with a minimally invasive approach of the chest at Swedish Medical Center-First Hill. These approaches include:
- 3 hole with R video-assisted thoracoscopic surgery (VATS)
- Ivor Lewis R VATS
- Transhiatal
Key exclusion criteria (6 listed)
- Age <18
- Unable to consent
- Additional surgical procedures planned
- Patient with chronic pain on a daily regimen of narcotics
- Patients who remain intubated greater than 24 hours post operatively
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 |
|---|---|---|
| EsophagectomyEsophagectomy with minimally invasive approach of the chest including: 3 hole with R video-assisted thoracoscopic surgery (VATS), Ivor Lewis R VATS, Transhiatal | Procedure or surgery | Transversus abdominis plane catheter, epidural |
| Transversus abdominis plane catheterAlso: TAP catheterTAP group will have bilateral subcostal TAP catheters and single shot bilateral rectus sheath blocks placed at the end of the surgery, prior to emergence. Bilateral subcostal TAP catheters will be bolused with 20ml of .2% ropivacaine on each side and then infused with .2% ropivacaine at 10ml/ hr for 75 hours each. Rectus sheath blocks will be bilateral bolus 20ml of .2% ropivacaine | Procedure or surgery | Transversus abdominis plane catheter |
| EpiduralAlso: TEPPatients randomize the TEP group will have bilateral TEP placed at T8-9 +/- one level based on patient anatomy. TEP will be bolused with 5ml of 1.5% lidocaine with epinephrine and then started on infusion of .0625% bupivacaine plus 4 mcg/ml fentanyl plus 2 mcg/ ml epinephrine at 6ml/hr with a range of 6-12 ml/hr, titrating to optimize patient comfort. Epidurals are placed before surgery start time. | Procedure or surgery | epidural |
Primary outcome
Pain scores
Time frame: Up to post-operative day 4
Pain scores on a scale of 0-10 will be collected from patients twice a day
2 secondary outcomes
Volume Resuscitation
Time frame: Up to post-operative day 4
Hypotension
Time frame: Up to post-operative day 4
Results and safety
The study was stopped early (reason given: COVID 19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Brian E Louie, MD principal investigator
Swedish Cancer Institute and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophagectomy, Transversus abdominis plane catheter and Epidural in people with Esophageal Cancer and Pain, Postoperative, run by Swedish Medical Center 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 4 inclusion and 6 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 23 Jan 2023. 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?
The study was stopped early (reason given: COVID 19). Results are not available in the source record.
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?
Pain scores (time frame: Up to post-operative day 4). 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 23 Jan 2023.