Pain, PostoperativePhase 4NCT04284930
Comparison of Local Anesthetic Infusion Pump Versus Depofoam Bupivacaine for Pain Management
A Phase 4 study testing Depobupivacaine, OnQ pump and 0.25% Bupivacaine in people with Pain, Postoperative, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Effective post surgical pain control in patients undergoing unilateral deep inferior epigastric perforator (DIEP) free flap reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Depobupivacaine, OnQ pump and 0.25% Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Nov 2017
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non pregnant women
- age 18 years or older
- scheduled to have unilateral DIEP flap breast reconstruction.
- Must have ASA physical status classification of 1,2, or 3
Who cannot join
- concurrent or recent medical condition that could interfere with study participation
- history of any of the following:
- hepatitis
- alcohol/substance abuse
- uncontrolled psychiatric disorders
- known allergy/ contraindication to any of the following:
Show all 12Show fewer
- amide-type local anesthetics
- opioids
- propofol
- Body weight of less than 50 kg
- have participated in another study involving an investigational medication with in the past 30 days
- taking analgesics, antidepressants, or glucocorticoids within the 3 days before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Controlled Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine For Pain Management After Unilateral Deep Inferior Epigastic Perforator Free Flap Reconstruction
Effective post surgical pain control in patients undergoing unilateral deep inferior epigastric perforator (DIEP) free flap reconstruction.
Read the detailed description
Critical to patient recovery, and can contribute to faster patient mobilization, shorter hospital stays and reduced health care costs. The administration of local anesthetics via wound infiltration is standard of care and an effective practice for post surgical pain management, However this method only provides relatively brief analgesia, usually lasting only 12 hours. Other FDA approved delivery systems using an indwelling fusion pump catheter (On-Q pump) are currently being used in our practice and may be used to extend the duration of action of locally administered analgesia by continuously infusing anesthetic into the wound. Alternatively, a depot form of bupivacaine has been FDA approved and currently used to deliver a single dose administered via wound infiltration for prolonged analgesia by allowing for the diffusion of the drug over an extended period of time. Both of these products are used as a standard practice during DIEP free flap reconstructions. However, no studies compare the efficacy of these two methods patients undergong unilateral DIEP flap reconstructions has been done in a prospective, randomized control manner.
- Conditions
- Pain, Postoperative
- Being tested
- Depobupivacaine, OnQ pump, 0.25% Bupivacaine
- Keywords
- local anesthetic continuous infusion pump, local injection of Exparel
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepobupivacaineDrug
Also called Exparel
surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia.
OnQ pumpDrug
group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure.
0.25% BupivacaineDrug
Also called Marcaine
group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.
| Study group | Role | What they receive |
|---|---|---|
| Depobupivacaine | Experimental | Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml. Receives: Drug: Depobupivacaine |
| OnQ Pump | Active comparator | Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour. Receives: Drug: OnQ pump |
| bupivacaine | Active comparator | Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine. Receives: Drug: 0.25% Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Narcotic Usage
Post-op pain measured by total post-op Morphine equivalents
Measured: total hospital stay, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study startFeb 2016
- Primary completionNov 2017
- Study completionNov 2017
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, PostoperativeStudies of the same condition, open and under way.
- More trials run by The Cleveland 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Risal Djohan, The Cleveland Clinic
- Investigators
- Risal Djohan, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284930
- Sponsor's protocol ID
- 15-1535
- Status last verified
- Dec 2020
- First submitted
- 12 Aug 2016
- Last updated
- 7 Jan 2021
- 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 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine For Pain Management After Unilateral Deep Inferior Epigastic Perforator Free Flap Reconstruction
- ClinicalTrials.gov ID
- NCT04284930
- Acronym / sponsor ID
- 15-1535
- Conditions
- Pain, Postoperative
- Keywords
- local anesthetic continuous infusion pump, local injection of Exparel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Posted 7 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effective post surgical pain control in patients undergoing unilateral deep inferior epigastric perforator (DIEP) free flap reconstruction.
Detailed description
Critical to patient recovery, and can contribute to faster patient mobilization, shorter hospital stays and reduced health care costs. The administration of local anesthetics via wound infiltration is standard of care and an effective practice for post surgical pain management, However this method only provides relatively brief analgesia, usually lasting only 12 hours. Other FDA approved delivery systems using an indwelling fusion pump catheter (On-Q pump) are currently being used in our practice and may be used to extend the duration of action of locally administered analgesia by continuously infusing anesthetic into the wound. Alternatively, a depot form of bupivacaine has been FDA approved and currently used to deliver a single dose administered via wound infiltration for prolonged analgesia by allowing for the diffusion of the drug over an extended period of time. Both of these products are used as a standard practice during DIEP free flap reconstructions. However, no studies compare the efficacy of these two methods patients undergong unilateral DIEP flap reconstructions has been done in a prospective, randomized control manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Depobupivacaine | Experimental | Drug: DepobupivacaineGroup 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml. |
| OnQ Pump | Active comparator | Drug: OnQ pumpGroup 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour. |
| bupivacaine | Active comparator | Drug: 0.25% BupivacaineGroup 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non pregnant women
- age 18 years or older
- scheduled to have unilateral DIEP flap breast reconstruction.
- Must have ASA physical status classification of 1,2, or 3
Key exclusion criteria (12 listed)
- concurrent or recent medical condition that could interfere with study participation
- history of any of the following:
- hepatitis
- alcohol/substance abuse
- uncontrolled psychiatric disorders
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 |
|---|---|---|
| DepobupivacaineAlso: Exparelsurgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia. | Drug | Depobupivacaine |
| OnQ pumpgroup 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure. | Drug | OnQ Pump |
| 0.25% BupivacaineAlso: Marcainegroup 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle. | Drug | bupivacaine |
Primary outcome
Total Narcotic Usage
Time frame: total hospital stay, an average of 3 days
Post-op pain measured by total post-op Morphine equivalents
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Risal Djohan, MD principal investigator
The Cleveland 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 Depobupivacaine, OnQ pump and 0.25% Bupivacaine in people with Pain, Postoperative, run by The Cleveland 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 4 inclusion and 12 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 7 Jan 2021. 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 7 Jan 2021). 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?
Total Narcotic Usage (time frame: total hospital stay, an average of 3 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 7 Jan 2021.