Pain Following Thoracotomy SurgeryPhase 4NCT02178553
Study of Exparel Versus Epidural for Pain Control After Thoracotomy
A Phase 4 study testing Epidural and Intercostal Bupivicaine (Exparel) in people with Pain Following Thoracotomy Surgery, run by Mayo Clinic at 1 site in United States.
Trial summary
Unilateral intercostal nerve blocks provide pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Following Thoracotomy Surgery
- What is being tested?
- Epidural and Intercostal Bupivicaine (Exparel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2014to 25 Jan 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection or pneumonectomy).
Who cannot join
- Planned chest wall resection or abdominal incision and/or gastroesophageal surgery;
- Current enrollment in another post-thoracotomy analgesic research protocol; pre-existing pain syndrome (such as fibromyalgia, complex regional pain syndrome or postherpetic neuralgia in a thoracic distribution);
- Daily opioid therapy;
- Current gabapentin or pregabalin therapy;
- Allergy to any study medication; coagulation or infectious issues that would preclude epidural catheter placement;
- Severe psychological disorders or inability to understand the study protocol; -Prisoners or other institutionalized individuals;
- Severe hepatic, renal or cardiovascular disorders.
- Women who are pregnant will not be included in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Non-inferiority Trial of Continuous Thoracic Epidural Analgesia Versus Single Intercostal Nerve Block After Thoracotomy
Unilateral intercostal nerve blocks provide pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects.
Read the detailed description
In this study we will study to see if a single set of unilateral intercostal nerve blocks provides pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects. Although the anesthesiologists involved in providing care for patients having thoracotomy incisions at St. Mary's Hospital are experts at placing thoracic epidural catheters, this study will attempt to show that a less technically challenging procedure done by surgeons intra-operatively can provide comparable pain relief.
- Conditions
- Pain Following Thoracotomy Surgery
- Being tested
- Epidural, Intercostal Bupivicaine (Exparel)
- Keywords
- Thoracotomy, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiduralDrug
Intercostal Bupivicaine (Exparel)Drug
| Study group | Role | What they receive |
|---|---|---|
| Epidural | Active comparator | In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr. Receives: Drug: Epidural |
| Intercostal bupivicaine (Exparel) | Active comparator | In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered. Receives: Drug: Intercostal Bupivicaine (Exparel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores With Cough on First Postoperative Day
Pain with cough documented using the numerical rating scale pain scores (0-10)
Measured: In the morning (8 am) on first postoperative day
Pain Scores With Cough on the Second Postoperative Day
Pain with cough documented using the numerical rating scale pain scores (0-10). Zero indicates no pain, and 10 indicates the worst pain one could imagine.
Measured: In the morning (8 am) on the second postoperative day
Secondary outcomes (2)
Pain Scores at Rest in the Morning on the First Postoperative Day
NRS pain scores on a 0-10 scale at rest at 8 am on the first postoperative day. Zero indicates no pain, and 10 indicates the worst pain one could imagine.
Measured: Each morning for two days postoperative
Pain Scores at Rest on the Second Postoperative Day
NRS pain scores on a 0-10 scale at rest in the morning on the second postoperative day. Zero indicates no pain, and 10 indicates the worst pain one could imagine.
Measured: Each morning for two days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study start15 Oct 2014
- Primary completion9 Oct 2018
- Study completion25 Jan 2019
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 Following Thoracotomy SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James D. Hannon, M.D., Mayo Clinic
- Investigators
- James D Hannon, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178553
- Sponsor's protocol ID
- 14-002940
- Status last verified
- Nov 2019
- First submitted
- 27 Jun 2014
- Last updated
- 9 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Non-inferiority Trial of Continuous Thoracic Epidural Analgesia Versus Single Intercostal Nerve Block After Thoracotomy
- ClinicalTrials.gov ID
- NCT02178553
- Acronym / sponsor ID
- 14-002940
- Conditions
- Pain Following Thoracotomy Surgery
- Keywords
- Thoracotomy, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Oct 2014 (actual)
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Posted 9 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Unilateral intercostal nerve blocks provide pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects.
Detailed description
In this study we will study to see if a single set of unilateral intercostal nerve blocks provides pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects. Although the anesthesiologists involved in providing care for patients having thoracotomy incisions at St. Mary's Hospital are experts at placing thoracic epidural catheters, this study will attempt to show that a less technically challenging procedure done by surgeons intra-operatively can provide comparable pain relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural | Active comparator | Drug: EpiduralIn the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr. |
| Intercostal bupivicaine (Exparel) | Active comparator | Drug: Intercostal Bupivicaine (Exparel)In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years and older
- Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection or pneumonectomy).
Key exclusion criteria (8 listed)
- Planned chest wall resection or abdominal incision and/or gastroesophageal surgery;
- Current enrollment in another post-thoracotomy analgesic research protocol; pre-existing pain syndrome (such as fibromyalgia, complex regional pain syndrome or postherpetic neuralgia in a thoracic distribution);
- Daily opioid therapy;
- Current gabapentin or pregabalin therapy;
- Allergy to any study medication; coagulation or infectious issues that would preclude epidural catheter placement;
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 |
|---|---|---|
| Epidural | Drug | Epidural |
| Intercostal Bupivicaine (Exparel) | Drug | Intercostal bupivicaine (Exparel) |
Primary outcome
Pain Scores With Cough on First Postoperative Day
Time frame: In the morning (8 am) on first postoperative day
Pain with cough documented using the numerical rating scale pain scores (0-10)
Pain Scores With Cough on the Second Postoperative Day
Time frame: In the morning (8 am) on the second postoperative day
Pain with cough documented using the numerical rating scale pain scores (0-10). Zero indicates no pain, and 10 indicates the worst pain one could imagine.
2 secondary outcomes
Pain Scores at Rest in the Morning on the First Postoperative Day
Time frame: Each morning for two days postoperative
Pain Scores at Rest on the Second Postoperative Day
Time frame: Each morning for two days postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pain Following Thoracotomy Surgery
RecruitingObservational study
Continuous Erector Spinae Block Versus Thoracic Epidural Analgesia for the Prevention of Chronic Pain Following Thoracotomy: a Retrospective Study
Thoracic Surgery
Recruiting
SPS Block vs. Surgical Intercostal Block for Chronic Pain After Thoracoscopic Surgery
Chronic Post-thoracotomy Pain, Neuropathic Pain
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.
James D Hannon, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epidural and Intercostal Bupivicaine (Exparel) in people with Pain Following Thoracotomy Surgery, run by Mayo Clinic 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: finished, as of the sponsor's last update on 9 Jan 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2020). 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?
Pain Scores With Cough on First Postoperative Day (time frame: In the morning (8 am) on first postoperative day). The study lists 2 primary outcomes in all. 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 9 Jan 2020.