Pain, PostoperativePhase 4NCT04278846

Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander

A Phase 4 study testing Depofoam bupivacaine and Bupivacaine hydrochloride (HCl) in people with Pain, Postoperative and Mammaplasty, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Patients undergoing breast reconstruction with tissue expanders will be treated with a local anesthetic during their procedure and monitor their post-operative pain level and amount of oral pain medication taken. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pain, Postoperative, Mammaplasty
What is being tested?: Depofoam bupivacaine and Bupivacaine hydrochloride (HCl)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 22 Aug 2014to 15 May 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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

undergoing breast reconstruction with tissue expander

Who cannot join

history of adverse reaction to local anesthesia
chronic liver disease
history of chronic preoperative consumption of narcotics or opioids
history of alcohol and/or illicit drug dependence
undergoing combined procedures
diagnosed with neuromuscular/neurosensory disorder

Show all 11Show fewer

positive pregnancy test
previous breast conservation therapy (lumpectomy with radiation treatment
previous surgeries or trauma in the breast or chest region (denervation may bias pain perception)
axillary node dissection
psychosis.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

Read the detailed description

Fifty consecutive (25 per arm) patients undergoing unilateral or bilateral breast reconstruction with tissue expanders will be administered intraoperatively in a standardized manner with either bupivicaine HCl (control group) or liposomal bupivacaine/Exparel (experimental group). Pain will be assessed qualitatively through the use of: 1) numeric rating scale during rest (NRS-R) and activity (NRS-A), 2) brief pain inventory (BPI) questionnaire, and 3) postoperative analgesia patient satisfaction scale. Furthermore, investigators will record the use of rescue analgesics for each patient. This part of the study will provide quantitative data that investigators can then use in comparison to the qualitative measurements (NSR, BPI, patient satisfaction scale rate). In turn, this will allow us to objectify patient's pain, thereby increasing the validity of our results. More importantly, this aspect of the investigation will enable us to study the impact that liposomal bupivacaine has in reducing the postoperative usage of opioid medications in this patient population. As this is a pilot study, a sample size of 50 total patients (25 per treatment group) is planned. This sample size should provide estimates of potential effect sizes and variability in the present setting to allow for future study planning. This study should provide adequate evidence of whether pain decreases of 15% or more are unlikely in this setting.

Investigators aim to evaluate the effectiveness of DepoFoam Bupivicaine (Exparel®) to reduce postoperative pain in breast reconstruction patients compared to the current standard treatment (bupivacaine HCl). Investigators hypothesize that patients undergoing breast reconstruction with tissue expander will achieve greater control of post-operative pain and longer lasting analgesia with the use of liposomal bupivacaine.

Conditions: Pain, Postoperative, Mammaplasty
Being tested: Depofoam bupivacaine, Bupivacaine hydrochloride (HCl)
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Depofoam bupivacaineDrug
Also called liposomal bupivacaine, Exparel
The study drug Depofoam bupivacaine will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
Bupivacaine hydrochloride (HCl)Drug
Also called Marcaine
The study drug bupivacaine HCl will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.

Study groups in NCT04278846
Study group	Role	What they receive
DepoFoam bupivacaine	Experimental	local anesthetic Receives: Drug: Depofoam bupivacaine
Bupivacaine hydrochloride (HCl)	Active comparator	local anesthetic Receives: Drug: Bupivacaine hydrochloride (HCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

1 Hour Pain Assessment Numeric Rating Scale During Rest
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R) Scale name: Numeric rating scale during rest (NRS-R) The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)
Measured: 1 hour post-operatively
8-12 Hour Pain Assessment Numeric Rating Scale During Rest
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R) The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)
Measured: 8-12 hours post-operatively
24 Hour Pain Assessment Numeric Rating Scale During Rest
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R).
The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)
Measured: 24 hours post-operatively
36 Hour Pain Assessment Numeric Rating Scale During Rest
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R).
The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)
Measured: 36 hours post-operatively
48 Hour Pain Assessment Numeric Rating Scale During Rest
Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R).
The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
Measured: 48 hours post-operatively
60 Hour Pain Assessment Numeric Rating Scale During Rest
Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R).
The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
Measured: 60 hours post-operatively
72 Hour Pain Assessment Numeric Rating Scale During Rest
Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R).
The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
Measured: 72 hours post-operatively
84 Hour Pain Assessment Numeric Rating Scale During Rest
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R).
The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
Measured: 84 hours post-operatively
96 Hour Pain Assessment Numeric Rating Scale During Rest
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R).
The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) Range 0-10
Measured: 96 hours post-operatively
36 Hour Pain Assessment Numeric Rating Scale During Activity
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).
The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
Measured: 36 hours post-operatively
48 Hour Pain Assessment Numeric Rating Scale During Activity
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).
The higher scores indicate more severe pain during activity (10 meaning the worst pain,0 meaning no pain) The range is 0 to 10.
Measured: 48 hours post-operatively
60 Hour Pain Assessment Numeric Rating Scale During Activity
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).
The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
Measured: 60 hours post-operatively
72 Hour Pain Assessment Numeric Rating Scale During Activity
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).
The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
Measured: 72 hours post-operatively
84 Hour Pain Assessment Numeric Rating Scale During Activity
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).
The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
Measured: 84 hours post-operatively
96 Hour Pain Assessment Numeric Rating Scale During Activity
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).
The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
Measured: 96 hours post-operatively
24 Hour Pain Assessment Brief Pain Inventory
Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain
Measured: 24 hours post-operatively
48 Hour Pain Assessment Brief Pain Inventory
Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain
Measured: 48 hours post-operatively
72 Hour Pain Assessment Brief Pain Inventory
Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain
Measured: 72 hours post-operatively
96 Hour Pain Assessment Brief Pain Inventory
Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain
Measured: 96 hours post-operatively
96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction
Pain will be assessed qualitatively through the use of post-operative analgesia patient satisfaction scale (0-5) The higher scores indicate more satisfied patients.( 5 would be very satisfied-less pain, 0 would indicate unsatisfied patients-more pain)
Measured: 96 hours post-operatively

Secondary outcomes (4)

24 Hour Use of Rescue Analgesic
We will record the amount in milligrams and type of rescue analgesic for each patient.
Measured: 24 hours post operatively
48 Hour Use of Rescue Analgesic
We will record the amount in milligrams and type of rescue analgesic for each patient.
Measured: 48 hours post operatively
72 Hour Use of Rescue Analgesic
We will record the amount in milligrams and type of rescue analgesic for each patient.
Measured: 72 hours post operatively
96 Hour Use of Rescue Analgesic
We will record the amount in milligrams and type of rescue analgesic for each patient.
Measured: 96 hours post operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 201415 May 2019

First posted20 Feb 2020
Study start22 Aug 2014
Primary completion31 Dec 2017
Study completion15 May 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, 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: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04278846
Sponsor's protocol ID: 14-903
Status last verified: Jun 2022
First submitted: 28 Dec 2016
Last updated: 1 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pain, Postoperative trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander
ClinicalTrials.gov ID: NCT04278846
Acronym / sponsor ID: 14-903
Conditions: Pain, Postoperative, Mammaplasty
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Collaborators: Pacira Pharmaceuticals, Inc
Study start: 22 Aug 2014 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 15 May 2019 (actual)
First posted: 20 Feb 2020 (actual)
Results: Posted 1 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DepoFoam bupivacaine	Experimental	Drug: Depofoam bupivacainelocal anesthetic
Bupivacaine hydrochloride (HCl)	Active comparator	Drug: Bupivacaine hydrochloride (HCl)local anesthetic

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

undergoing breast reconstruction with tissue expander

Key exclusion criteria (11 listed)

history of adverse reaction to local anesthesia
chronic liver disease
history of chronic preoperative consumption of narcotics or opioids
history of alcohol and/or illicit drug dependence
undergoing combined procedures

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
Depofoam bupivacaineAlso: liposomal bupivacaine, ExparelThe study drug Depofoam bupivacaine will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Drug	DepoFoam bupivacaine
Bupivacaine hydrochloride (HCl)Also: MarcaineThe study drug bupivacaine HCl will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Drug	Bupivacaine hydrochloride (HCl)

Primary outcome

1 Hour Pain Assessment Numeric Rating Scale During Rest
Time frame: 1 hour post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R) Scale name: Numeric rating scale during rest (NRS-R) The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)
8-12 Hour Pain Assessment Numeric Rating Scale During Rest
Time frame: 8-12 hours post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R) The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)
24 Hour Pain Assessment Numeric Rating Scale During Rest
Time frame: 24 hours post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)
36 Hour Pain Assessment Numeric Rating Scale During Rest
Time frame: 36 hours post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)
48 Hour Pain Assessment Numeric Rating Scale During Rest
Time frame: 48 hours post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
60 Hour Pain Assessment Numeric Rating Scale During Rest
Time frame: 60 hours post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
72 Hour Pain Assessment Numeric Rating Scale During Rest
Time frame: 72 hours post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
84 Hour Pain Assessment Numeric Rating Scale During Rest
Time frame: 84 hours post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
96 Hour Pain Assessment Numeric Rating Scale During Rest
Time frame: 96 hours post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) Range 0-10
36 Hour Pain Assessment Numeric Rating Scale During Activity
Time frame: 36 hours post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
48 Hour Pain Assessment Numeric Rating Scale During Activity
Time frame: 48 hours post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain,0 meaning no pain) The range is 0 to 10.
60 Hour Pain Assessment Numeric Rating Scale During Activity
Time frame: 60 hours post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
72 Hour Pain Assessment Numeric Rating Scale During Activity
Time frame: 72 hours post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
84 Hour Pain Assessment Numeric Rating Scale During Activity
Time frame: 84 hours post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
96 Hour Pain Assessment Numeric Rating Scale During Activity
Time frame: 96 hours post-operatively
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.
24 Hour Pain Assessment Brief Pain Inventory
Time frame: 24 hours post-operatively
Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain
48 Hour Pain Assessment Brief Pain Inventory
Time frame: 48 hours post-operatively
Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain
72 Hour Pain Assessment Brief Pain Inventory
Time frame: 72 hours post-operatively
Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain
96 Hour Pain Assessment Brief Pain Inventory
Time frame: 96 hours post-operatively
Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain
96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction
Time frame: 96 hours post-operatively
Pain will be assessed qualitatively through the use of post-operative analgesia patient satisfaction scale (0-5) The higher scores indicate more satisfied patients.( 5 would be very satisfied-less pain, 0 would indicate unsatisfied patients-more pain)

4 secondary outcomes

24 Hour Use of Rescue Analgesic
Time frame: 24 hours post operatively
48 Hour Use of Rescue Analgesic
Time frame: 48 hours post operatively
72 Hour Use of Rescue Analgesic
Time frame: 72 hours post operatively
96 Hour Use of Rescue Analgesic
Time frame: 96 hours post operatively

Results and safety

Results posted to the registry on 1 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DepoFoam Bupivacaine	25	25
Bupivacaine HCl	25	25

Primary outcome: 1 Hour Pain Assessment Numeric Rating Scale During Rest

Time frame: 1 hour post-operatively. Median (Inter-Quartile Range). Unit: units on a scale

Measure	DepoFoam Bupivacaine n = 25	Bupivacaine HCl n = 25
Value	5 (3 to 6)	5 (3 to 6)

DepoFoam Bupivacaine vs Bupivacaine HCl: p = .87, Kruskal-Wallis

Population analysed: All randomized patients

Primary outcome: 8-12 Hour Pain Assessment Numeric Rating Scale During Rest

Time frame: 8-12 hours post-operatively. Median (Inter-Quartile Range). Unit: units on a scale

Measure	DepoFoam Bupivacaine n = 25	Bupivacaine HCl n = 25
Value	3 (2 to 4)	3 (2 to 4)

DepoFoam Bupivacaine vs Bupivacaine HCl: p = .49, Kruskal-Wallis

Population analysed: All randomized patients

Primary outcome: 24 Hour Pain Assessment Numeric Rating Scale During Rest

Time frame: 24 hours post-operatively. Median (Inter-Quartile Range). Unit: units on a scale

Measure	DepoFoam Bupivacaine n = 23	Bupivacaine HCl n = 24
Value	3 (2 to 5)	3.5 (2.5 to 5)

DepoFoam Bupivacaine vs Bupivacaine HCl: p = .57, Kruskal-Wallis

Population analysed: All randomized patients who completed the tools

Primary outcome: 36 Hour Pain Assessment Numeric Rating Scale During Rest

Time frame: 36 hours post-operatively. Median (Inter-Quartile Range). Unit: units on a scale

Measure	DepoFoam Bupivacaine n = 25	Bupivacaine HCl n = 24
Value	3 (2 to 5)	3 (2 to 4)

DepoFoam Bupivacaine: p = .3, Kruskal-Wallis

Population analysed: All randomized patients who completed the tools

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: The following adverse events will be evaluated: 1) nausea; 2) vomiting; 3) constipation; 4) somnolence; 5) dizziness; 6) respiratory distress. They will be assessed at 1, 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after the administration of the local anesthetics.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DepoFoam Bupivacaine	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Bupivacaine HCl	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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.

Raymond Isakov, 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 Depofoam bupivacaine and Bupivacaine hydrochloride (HCl) in people with Pain, Postoperative and Mammaplasty, 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 1 inclusion and 11 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 1 Jul 2022. 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 1 Jul 2022). 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?

1 Hour Pain Assessment Numeric Rating Scale During Rest (time frame: 1 hour post-operatively). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04278846.

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 1 Jul 2022.