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| Name | Class |
|---|---|
| Jewish Hospital and St. Mary's Healthcare | OTHER |
| Baptist Health | OTHER |
| Kleinert, Kutz and Associates | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Retrospective Controls | No Intervention | Controls will be gathered retrospectively from chart reviews where patient did not receive a intercostal nerve blocker bilaterally. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Hydrochloride | Drug | See group descriptions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | 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) | 120 minutes post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, average of 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julianne Sutton, MPH | Contact | 5025620390 | jsutton@klienertkutz.com |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Palazzo, MD | Christine M. Kleinert Institute for Hand and Microsurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulatory Surgery Center, Kleinert Kutz Hand Care Center | Recruiting | New Albany | Indiana | 47150 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32629834 | Result | 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. |
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Only those researchers involved with the trial will have access to the individual participant data
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Cases will be recruited prospectively and controls will be taken retrospectively
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The statistician will be masked to the groups the participants fall in (case vs control).
| Baptist Health Floyd | Recruiting | New Albany | Indiana | 47150 | United States |
|
| Christine M Kleinert Institute for Hand and Microsurgery | Recruiting | Louisville | Kentucky | 40202 | United States |
|
| HCCOC, Jewish Hospital | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Baptist Health Louisville | Recruiting | Louisville | Kentucky | 40207 | United States |
|
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |