Pain, PostoperativePhase 4NCT04606836
ICNBs for Post-op Pain in Breast Surgery
A Phase 4 study testing Bupivacaine Hydrochloride in people with Pain, Postoperative and Length of Stay, run by Christine M. Kleinert Institute for Hand and Microsurgery at 5 sites in United States.
Trial summary
The authors will conduct this study to analyze the effectiveness of peri-operative intercostal nerve blocks (ICNBs) in reducing acute postoperative pain after reconstructive breast surgery and mammoplasty and how it affects the length of hospital stay. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Pain, Postoperative, Length of Stay
- What is being tested?
- Bupivacaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Dec 2020to Aug 2021
- Phase
- Phase 4
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists Classification (ASA Class) 3 and below.
- Bilateral or unilateral breast surgery including cancer extirpation, reconstruction (implant and expander), oncoplastic surgery (<200 gm), breast augmentation and breast reduction, etc.
Who cannot join
- Patients who refuse local anesthesia.
- Patients who cannot receive local anesthesia.
- Below the age of 20 and above the age of 70.
- Patients requiring reoperation due to complications of mammoplasty or another breast surgery.
- Poorly controlled diabetics, uncontrolled hypertension, heart disease, arrhythmias, diagnosed with bipolar and generalized anxiety disorders.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Christine M Kleinert Institute for Hand and Microsurgery
Louisville, Kentucky, 40202
Michelle Palazzo, MD, mpalazzo@kleinertkutz.com
Julianne Sutton, MPH, 5025620390, jsutton@kleinertkutz.com
- Recruiting
HCCOC, Jewish Hospital
Louisville, Kentucky, 40202
Michelle Palazzo, MD, mpalazzo@kleinertkutz.com
Uzair Qazi, MD
- Recruiting
Baptist Health Louisville
Louisville, Kentucky, 40207
Michelle Palazzo, MD, mpalazzo@kleinertkutz.com
Michelle Palazzo, MD
- Recruiting
Ambulatory Surgery Center, Kleinert Kutz Hand Care Center
New Albany, Indiana, 47150
Michelle Palazzo, MD, mpalazzo@kleinertkutz.com
Michelle Palazzo, MD
- Recruiting
Baptist Health Floyd
New Albany, Indiana, 47150
Michelle Palazzo, MD, mpalazzo@kleinertkutz.com
Michelle Palazzo, MD
About this study
Official title: Analyzing the Efficacy of Peri-operative Intercostal Nerve Blocks ICNB for Acute Postoperative Pain Control in Reconstructive Breast Surgery and Mammoplasty
The authors will conduct this study to analyze the effectiveness of peri-operative intercostal nerve blocks (ICNBs) in reducing acute postoperative pain after reconstructive breast surgery and mammoplasty and how it affects the length of hospital stay.
- Conditions
- Pain, Postoperative, Length of Stay
- Being tested
- Bupivacaine Hydrochloride
- Keywords
- ICNB, pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
Also called Marcaine
See group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cases | Experimental | These cases will be recruited prospectively, and receive the intercostal nerve block(s) on operated site(s). Peri-operative injections of 30 ml of 0.25% Bupivacaine each, injected over the 4th, 5th, and 6th ribs on the operated site(s). Receives: Drug: Bupivacaine Hydrochloride |
| Retrospective Controls | No intervention | Controls will be gathered retrospectively from chart reviews where patient did not receive a intercostal nerve blocker bilaterally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)
Measured: Immediately post-operation
Post-operative pain
Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)
Measured: 30 minutes post-operation
Post-operative pain
Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)
Measured: 60 minutes post-operation
Post-operative pain
Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)
Measured: 120 minutes post-operation
Secondary outcomes (1)
Length of Hospital Stay
time of discharge compared with time of surgery completion; Measured in number of days spent in hospital, i.e., 1 day
Measured: Through study completion, average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start7 Dec 2020
- Primary completionApr 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cases will be recruited prospectively and controls will be taken retrospectively
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christine M. Kleinert Institute for Hand and Microsurgery
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish Hospital and St. Mary's Healthcare, Baptist Health, Kleinert, Kutz and Associates
- Responsible party
- Sponsor
- Investigators
- Michelle Palazzo, MD, Principal investigator, Christine M. Kleinert Institute for Hand and Microsurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606836
- Sponsor's protocol ID
- 20.0781
- Status last verified
- Dec 2020
- First submitted
- 12 Oct 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Only those researchers involved with the trial will have access to the individual participant data
Publications
Park JW, Kim JH, Woo KJ. Intraoperative Intercostal Nerve Block for Postoperative Pain Control in Pre-Pectoral versus Subpectoral Direct-to-Implant Breast Reconstruction: A Retrospective Study. Medicina (Kaunas). 2020 Jun 30;56(7):325. doi: 10.3390/medicina56070325.
PubMed 32629834
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing the Efficacy of Peri-operative Intercostal Nerve Blocks ICNB for Acute Postoperative Pain Control in Reconstructive Breast Surgery and Mammoplasty
- ClinicalTrials.gov ID
- NCT04606836
- Acronym / sponsor ID
- 20.0781
- Conditions
- Pain, Postoperative, Length of Stay
- Keywords
- ICNB, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Christine M. Kleinert Institute for Hand and MicrosurgeryUniversity, hospital or other
- Collaborators
- Jewish Hospital and St. Mary's Healthcare, Baptist Health, Kleinert, Kutz and Associates
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 28 Oct 2020 (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.
The authors will conduct this study to analyze the effectiveness of peri-operative intercostal nerve blocks (ICNBs) in reducing acute postoperative pain after reconstructive breast surgery and mammoplasty and how it affects the length of hospital stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Cases will be recruited prospectively and controls will be taken retrospectively
| Arm | Type | Receives |
|---|---|---|
| Prospective Cases | Experimental | Drug: Bupivacaine HydrochlorideThese cases will be recruited prospectively, and receive the intercostal nerve block(s) on operated site(s). Peri-operative injections of 30 ml of 0.25% Bupivacaine each, injected over the 4th, 5th, and 6th ribs on the operated site(s). |
| Retrospective Controls | No intervention | –Controls will be gathered retrospectively from chart reviews where patient did not receive a intercostal nerve blocker bilaterally. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists Classification (ASA Class) 3 and below.
- Bilateral or unilateral breast surgery including cancer extirpation, reconstruction (implant and expander), oncoplastic surgery (<200 gm), breast augmentation and breast reduction, etc.
Key exclusion criteria (5 listed)
- Patients who refuse local anesthesia.
- Patients who cannot receive local anesthesia.
- Below the age of 20 and above the age of 70.
- Patients requiring reoperation due to complications of mammoplasty or another breast surgery.
- Poorly controlled diabetics, uncontrolled hypertension, heart disease, arrhythmias, diagnosed with bipolar and generalized anxiety 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 |
|---|---|---|
| Bupivacaine HydrochlorideAlso: MarcaineSee group descriptions | Drug | Prospective Cases |
Primary outcome
Post-operative pain
Time frame: Immediately post-operation
Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)
Post-operative pain
Time frame: 30 minutes post-operation
Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)
Post-operative pain
Time frame: 60 minutes post-operation
Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)
Post-operative pain
Time frame: 120 minutes post-operation
Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)
1 secondary outcome
Length of Hospital Stay
Time frame: Through study completion, average of 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Results publication: PubMed 32629834Park JW, Kim JH, Woo KJ. Intraoperative Intercostal Nerve Block for Postoperative Pain Control in Pre-Pectoral versus Subpectoral Direct-to-Implant Breast Reconstruction: A Retrospective Study. Medicina (Kaunas). 2020 Jun 30;56(7):325. doi: 10.3390/medicina56070325.
- Individual participant dataSharing planned: No. Only those researchers involved with the trial will have access to the individual participant data
Related trials for Pain, Postoperative
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
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.
Michelle Palazzo, MD principal investigator
Christine M. Kleinert Institute for Hand and Microsurgery
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine Hydrochloride in people with Pain, Postoperative and Length of Stay, run by Christine M. Kleinert Institute for Hand and Microsurgery at 5 sites 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 5 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: status not confirmed, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julianne Sutton, MPH (5025620390, jsutton@klienertkutz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: Immediately post-operation). The study lists 4 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 NCT04606836, which also lists 1 linked publication.
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 Dec 2020.