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| ID | Type | Description | Link |
|---|---|---|---|
| 06-18-03 | Other Identifier | Atrium | |
| Pro00027862 | Other Identifier | Atrium |
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We aim to study the impact of perioperative IV lidocaine on postoperative pain control in patients undergoing paraesophageal hernia repair. This is in the context of an established ERAS protocol. We wish to study the effect of IV Lidocaine on postoperative short and long-term outcomes, including patients' length of stay postoperative mortality, morbidity, and quality of life. We will compare this to our standard pain management.
Patients will be prospectively enrolled from Carolinas Hernia Center's outpatient clinic. All paraesophageal hernia patients, age 18 and older, undergoing PEH repair at CHS will be included. We will conduct a two-arm prospective randomized study, IV Lidocaine versus placebo, to study the reduction of narcotics, return to bowel function and length of stay. Both arms will receive standard multimodal pain control in the operative and postoperative period. There will be two arms: 1. IV Lidocaine 2. Placebo. Subject participation will last approximately 6 months for this study. Lidocaine will be used as a perioperative adjunct. At the conclusion of the study, chart review will be performed to evaluate if Lidocaine infusion limited narcotic need, or effected Visual Analog Scale (VAS) values. VAS is the standard nursing method of documenting pain using pain scores. The nurses ask the patient to rate pain from 0 (no pain) to 10 (excruciating pain). LOS is a secondary endpoint of the study, as subjects in the lidocaine arm are hypothesized to have improved pain control and require lower narcotic dosing, potentially leading to earlier discharge. We will evaluate patient demographics, preoperative lab values, intraoperative and perioperative variables, as well as postoperative outcomes and pain reported by VAS. Postoperative data to be reviewed will also include total opioid analgesia administered, time from surgery to a clear liquid diet, time from surgery to a post-fundoplication diet, time to return of bowel function, length of stay, pain/VAS scores at 6 hours postoperatively, pain/VAS scores on each post-operative day until discharge, pain/VAS scores at 2 and 4 weeks, and pain/VAS scores at 6 months, infectious complications (urinary tract infections as well as surgical site infections, deep organ space infections, pneumonia), and non-infectious complications (stroke, myocardial infarction, respiratory failure, post-op bleeding, unplanned return to the OR, acute renal failure, death, etc.). When results of the study are published, the subject's identity will remain confidential. Data will be analyzed using standard statistical methods; all patient-identifying information will be removed prior to analysis. Descriptive statistics including means and standard deviations, medians and interquartile range, or counts and percentages, will be used to describe the study population on all variables. For continuous variables comparisons will be made between groups using t-tests and Wilcoxon Rank Sum test. For categorical variables, Chi-Square test and Kruskal-Wallis tests will be used for comparisons between groups. Multivariate regression will be performed as needed to control for potential confounding factors such as age, gender and type of procedure. A p-value of <0.05 will be used for all significance determinations. The SAS® system version 9.4 (Cary, NC) or similar program will be used to complete all statistical analyses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Lidocaine | Experimental | 100 mg Lidocaine bolus on induction, then an infusion of 1.5 mg/kg/hr to begin prior to incision, run throughout the operation and continues into PACU for 1 hour OR until one 2gm/250mL D5W bag has been infused, whichever occurs first. The Patient will be monitored by nursing staff with the aid of continuous cardiac monitoring in the PACU for at least 30 minutes after the discontinuation of the lidocaine drip. |
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| Placebo | Placebo Comparator | Patients will receive D5W solution at the same volume and rate as the IV lidocaine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV lidocaine | Drug | Patients randomized to the IV lidocaine group will receive a 100 mg lidocaine bolus on induction then an infusion of 1.5 mg/kg/hr prior to incision. This infusion will continue throughout operation and into the PACU for 1 hour OR until the 2gm/250 mL D5W bag has been infused, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Morphine Equivalents | Postoperative consumption of morphine equivalents | Post-operation up to 48 hours |
| Visual Analogue Scale Pain Score | Visual Analogue Scale pain score is the standard nursing method of documenting pain using pain scores. The nurses ask the patient to rate pain from 0 (no pain) to 10 (excruciating pain). | post-op to 6 months |
| Length of Stay | Length of postoperative stay | up to 1 week |
| Return of Bowel Function | We will track when each patient passes first bowel movement | up to week 1 |
| Hours to Toleration of Diet | Number of hours until patient tolerates a normal diet | up to day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul D Colavita, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health - Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Lidocaine | 100 mg Lidocaine bolus on induction, then an infusion of 1.5 mg/kg/hr to begin prior to incision, run throughout the operation and continues into PACU for 1 hour OR until one 2gm/250mL D5W bag has been infused, whichever occurs first. The Patient will be monitored by nursing staff with the aid of continuous cardiac monitoring in the PACU for at least 30 minutes after the discontinuation of the lidocaine drip. IV lidocaine: Patients randomized to the IV lidocaine group will receive a 100 mg lidocaine bolus on induction then an infusion of 1.5 mg/kg/hr prior to incision. This infusion will continue throughout operation and into the PACU for 1 hour OR until the 2gm/250 mL D5W bag has been infused, whichever occurs first. |
| FG001 | Placebo | Patients will receive D5W solution at the same volume and rate as the IV lidocaine. Placebo: o Patients randomized to the placebo group will receive D5W solution (as this is the carrier for lidocaine) at the same volume and rate as the IV lidocaine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Lidocaine | 100 mg Lidocaine bolus on induction, then an infusion of 1.5 mg/kg/hr to begin prior to incision, run throughout the operation and continues into PACU for 1 hour OR until one 2gm/250mL D5W bag has been infused, whichever occurs first. The Patient will be monitored by nursing staff with the aid of continuous cardiac monitoring in the PACU for at least 30 minutes after the discontinuation of the lidocaine drip. IV lidocaine: Patients randomized to the IV lidocaine group will receive a 100 mg lidocaine bolus on induction then an infusion of 1.5 mg/kg/hr prior to incision. This infusion will continue throughout operation and into the PACU for 1 hour OR until the 2gm/250 mL D5W bag has been infused, whichever occurs first. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Morphine Equivalents | Postoperative consumption of morphine equivalents | Posted | Mean | Standard Deviation | morphine milligram equivalents | Post-operation up to 48 hours |
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baseline to six months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV Lidocaine | 100 mg Lidocaine bolus on induction, then an infusion of 1.5 mg/kg/hr to begin prior to incision, run throughout the operation and continues into PACU for 1 hour OR until one 2gm/250mL D5W bag has been infused, whichever occurs first. The Patient will be monitored by nursing staff with the aid of continuous cardiac monitoring in the PACU for at least 30 minutes after the discontinuation of the lidocaine drip. IV lidocaine: Patients randomized to the IV lidocaine group will receive a 100 mg lidocaine bolus on induction then an infusion of 1.5 mg/kg/hr prior to incision. This infusion will continue throughout operation and into the PACU for 1 hour OR until the 2gm/250 mL D5W bag has been infused, whichever occurs first. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Greg Scarola, MS, MBA | Atrium Health | 704-355-5766 | gregory.scarola@advocatehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2022 | May 26, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 21, 2026 | May 26, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006551 | Hernia, Hiatal |
| ID | Term |
|---|---|
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo | Drug | o Patients randomized to the placebo group will receive D5W solution (as this is the carrier for lidocaine) at the same volume and rate as the IV lidocaine. |
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| BG001 | Placebo | Patients will receive D5W solution at the same volume and rate as the IV lidocaine. Placebo: o Patients randomized to the placebo group will receive D5W solution (as this is the carrier for lidocaine) at the same volume and rate as the IV lidocaine. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Placebo | Patients will receive D5W solution at the same volume and rate as the IV lidocaine. Placebo: o Patients randomized to the placebo group will receive D5W solution (as this is the carrier for lidocaine) at the same volume and rate as the IV lidocaine. |
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| Primary | Visual Analogue Scale Pain Score | Visual Analogue Scale pain score is the standard nursing method of documenting pain using pain scores. The nurses ask the patient to rate pain from 0 (no pain) to 10 (excruciating pain). | Discrepancies in participants at postoperative timeframes were due to some participants being discharged sooner than others. Discrepancies in participants at follow-up timeframes is due to participants missing follow-up appointments. | Posted | Mean | Standard Deviation | score on a scale | post-op to 6 months |
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| Primary | Length of Stay | Length of postoperative stay | Posted | Mean | Standard Deviation | days | up to 1 week |
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| Primary | Return of Bowel Function | We will track when each patient passes first bowel movement | Posted | Mean | Standard Deviation | days | up to week 1 |
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| Primary | Hours to Toleration of Diet | Number of hours until patient tolerates a normal diet | Posted | Mean | Standard Deviation | hours | up to day 2 |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Placebo | Patients will receive D5W solution at the same volume and rate as the IV lidocaine. Placebo: o Patients randomized to the placebo group will receive D5W solution (as this is the carrier for lidocaine) at the same volume and rate as the IV lidocaine. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| Incision Pain Postoperative Day 1 |
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| Incision Pain Postoperative Day 2 |
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| Incision Pain Postoperative Day 3 |
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| Incision Pain Postoperative Day 4 |
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| Incision Pain Postoperative Day 5 |
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| Incision Pain Week 2 |
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| Incision Pain Week 6 |
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| Incision Pain Month 6 |
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| Shoulder Pain Hour 6 Postoperative |
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| Shoulder Pain Postoperative Day 1 |
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| Shoulder Pain Postoperative Day 2 |
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| Shoulder Pain Postoperative Day 3 |
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| Shoulder Pain Postoperative Day 4 |
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| Shoulder Pain Postoperative Day 5 |
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| Postoperative Week 2 |
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| Postoperative Week 6 |
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| Postoperative Month 6 |
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