| ID | Type | Description | Link |
|---|---|---|---|
| HSC-MS-13-0620 | Other Identifier | UTHSC IRB |
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The purpose of this study is to assess the efficacy of the intraoperative injection of prolonged acting (liposomal) bupivacaine in postoperative pain control after truncal surgical incisions.
Study Design:
This is a prospective, single-institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing bupivacaine liposomal injectable suspension (Exparel®) versus regular bupivacaine hydrochloride (HCl).
Procedure:
In patients aged 18 and over who require sternotomy, thoracotomy, mini-thoracotomy, or laparotomy incisions will be screened and consented for potential enrollment. Patients will be randomized following consenting to either Exparel® or regular bupivacaine hydrochloride group.
Course of Study:
The study will accrue patients over the course of 4 years.
Enrollment:
Enrollment will consist of all adult patients aged 18 and over undergoing surgical procedures requiring sternotomy, thoracotomy, mini-thoracotomy, or laparotomy incisions. Patients will be screened and consented preoperatively. If the patient is deemed eligible and consents to participate, randomization will occur and the patient will be considered enrolled.
Recruitment:
The target for enrollment will be 280 patients (the study target sample size per power analysis, but actual enrollment will be greater (330 patients) to account for exclusions for various reasons in order to achieve the target recruitment).
Risks:
There is a small increased risk to the patients by participating in the study in addition to a possible chance of breach in patient confidentiality as the study involves evaluation of an FDA-approved drug. As detailed in the informed consent, the subjects are at risk of developing adverse effects from Exparel®, described on the drug packet insert and from HCl Bupivacaine, also described on the drug packet insert. The investigators do not expect any additional physical risks other than an unintentional disclosure of sensitive patient health information.
Data Safety Monitoring:
As the Principal Investigator of this study, Dr. Charlton-Ouw from the Department of Cardiothoracic and Vascular Surgery at The University of Texas at Houston Medical School will conduct the data safety monitoring of this study. He will annually meet with all other co-investigators to review the patients enrolled in this study. As part of the data safety monitoring plan, all patients enrolled until that point in time would be unblinded in order to review the outcomes. Additionally, in view of the uncertainty attached to the treatment effects in this heterogeneous population, owing to limited currently available data, an independent Data Safety Monitoring Committee, will oversee the progress of the trial.
IND#:
The drugs that will be used are already approved by the FDA and do not have IND/IDE#
Proposed Funding Source:
The study is internally funded and is investigator-initiated.
Communication of Study Results:
The communication of study results will occur only between authorized individuals who are listed to take part in the study through our department. The individuals who will take part in the study will acknowledge and adhere to the importance of patient safety and the protection of their private information. The results of this study will be analyzed and published after the approval of the principal investigator, co-investigators, and biostatistician in a peer-reviewed scientific journal and/or presented at an international/national scientific conference or meeting regardless of outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel® | Experimental | Patients in this group will receive will receive the study drug [bupivacaine liposomal injectable suspension (Exparel®)] and Patient Controlled Analgesia (PCA). Exparel® is an FDA-approved bupivacaine liposome injectable suspension produced by Pacira Pharmaceuticals. |
|
| Regular Bupivacaine | Active Comparator | Patients in this group will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension. The standard non-liposomal bupivacaine will be from Hospira pharmaceuticals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain"). | postoperative day 1 |
| Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain"). | postoperative day 2 |
| Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain"). | postoperative day 3 |
| Postoperative Pain as Assessed by a Five-point Satisfaction Scale | The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied). | postoperative day 1 |
| Postoperative Pain as Assessed by a Five-point Satisfaction Scale | The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied). | postoperative day 2 |
| Postoperative Pain as Assessed by a Five-point Satisfaction Scale | The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied). | postoperative day 3 |
| Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) | The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine"). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Opioid Use | The total amount in mg of opioid medication consumed through 12, 24, 36, 48, 60, and 72 hours after surgery will be assessed. | Over the first 72 hours after surgery |
| Mean Length of Hospital Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristofer M Charlton-Ouw, MD FACS | University of Texas Health Science Center, Department of Cardiothoracic and Vascular Surgery, UT Medical School at Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33724391 | Derived | Sandhu HK, Miller CC 3rd, Tanaka A, Estrera AL, Charlton-Ouw KM. Effectiveness of Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine for Postoperative Pain Control in Patients Undergoing Truncal Incisions: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e210753. doi: 10.1001/jamanetworkopen.2021.0753. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exparel® | Patients will receive will receive the study drug [bupivacaine liposomal injectable suspension (Exparel®)] and Patient Controlled Analgesia (PCA). Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure. Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day |
| FG001 | Regular Bupivacaine | Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension. Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure. Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exparel® | Patients will receive will receive the study drug [bupivacaine liposomal injectable suspension (Exparel®)] and Patient Controlled Analgesia (PCA). Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure. Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age wasn't collected for all participants. |
| 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 Pain as Assessed by a Numeric Pain Scale (NPS) | The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain"). | Intention-to-treat analysis. Data for this measure was collected for only 153 in the Exparel arm and 152 in the Regular Bupivacaine group. | Posted | Mean | Standard Deviation | units on a scale | postoperative day 1 |
|
30 days after surgery
Only adverse events that were related to the study drug were collected.
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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 | Exparel® | Patients will receive will receive the study drug [bupivacaine liposomal injectable suspension (Exparel®)] and Patient Controlled Analgesia (PCA). Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure. Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristofer M Charlton-Ouw | The University of Texas Health Science Center at Houston | (713) 486-5100 | Kristofer.CharltonOuw@uth.tmc.edu |
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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 | Sep 12, 2016 | Aug 20, 2018 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Prospective, blinded, controlled randomized clinical trial with 2-armed parallel-group sequential design
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Masking included all patients, who were blinded to the contents of the intraoperative injection, as well as partial blinding of the surgical team who were masked from the treatment allocation up until the time of injection following which the knowledge of drug was inevitable as Exparel® has a milky appearance as opposed to the colorless bupivacaine hydrochloride (standard) formulations.
|
|
| Bupivacaine hydrochloride | Drug | Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure. |
|
|
| Patient Controlled Analgesia (PCA) | Drug | Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day |
|
| postoperative day 1 |
| Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) | The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine"). | postoperative day 2 |
| Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) | The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine"). | postoperative day 3 |
Indirect outcome measure to assess the adequacy of postoperative pain control as an indicator of improvement in healing period, patient participation in physical therapy and faster patient mobilization, and overall health care cost
| Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Change From Baseline in Quality of Life | The impact of pain on patient's quality of life will be assessed through a brief pain inventory (BPI). In addition, the 5-point scale analgesia satisfaction survey will be used along with the BPI to assess patient satisfaction and quality of life. | Will be assessed preoperatively, on the first post-op day (POD 1), on POD2, and POD 3 |
| Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours | 72 hours after surgery |
| Hospital Cost for Patient Care During Hospitalization | Hospital cost for patient care during hospitalization will be estimated from hospital charges and financial records. | duration of hospital stay, an expected average of 4 weeks |
| BG001 | Regular Bupivacaine | Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension. Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure. Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity data wasn't collected from all participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race data wasn't collected from all participants. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Regular Bupivacaine | Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension. Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure. Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day |
|
|
|
| Primary | Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain"). | Intention-to-treat analysis. Data for this measure was collected for only 160 in the Exparel arm and 159 in the Regular Bupivacaine group. | Posted | Mean | Standard Deviation | units on a scale | postoperative day 2 |
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|
|
|
| Primary | Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain"). | Intention-to-treat analysis. Data for this measure was collected for only 159 in the Exparel arm and 151 in the Regular Bupivacaine group. | Posted | Mean | Standard Deviation | units on a scale | postoperative day 3 |
|
|
|
|
| Primary | Postoperative Pain as Assessed by a Five-point Satisfaction Scale | The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied). | Intention-to-treat analysis. Data for this measure was collected for only 144 in the Exparel arm and 146 in the Regular Bupivacaine group. | Posted | Mean | Standard Deviation | units on a scale | postoperative day 1 |
|
|
|
|
| Primary | Postoperative Pain as Assessed by a Five-point Satisfaction Scale | The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied). | Intention-to-treat analysis. Data for this measure was collected for only 155 in the Exparel arm and 155 in the Regular Bupivacaine group. | Posted | Mean | Standard Deviation | units on a scale | postoperative day 2 |
|
|
|
|
| Primary | Postoperative Pain as Assessed by a Five-point Satisfaction Scale | The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied). | Intention-to-treat analysis. Data for this measure was collected for only 148 in the Exparel arm and 148 in the Regular Bupivacaine group. | Posted | Mean | Standard Deviation | units on a scale | postoperative day 3 |
|
|
|
|
| Primary | Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) | The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine"). | Intention-to-treat analysis. Data for this measure was collected for only 142 in the Exparel arm and 140 in the Regular Bupivacaine group. | Posted | Mean | Standard Deviation | units on a scale | postoperative day 1 |
|
|
|
|
| Primary | Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) | The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine"). | Intention-to-treat analysis. Data for this measure was collected for only 151 in the Exparel arm and 149 in the Regular Bupivacaine group. | Posted | Mean | Standard Deviation | units on a scale | postoperative day 2 |
|
|
|
|
| Primary | Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) | The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine"). | Intention-to-treat analysis. Data for this measure was collected for only 150 in the Exparel arm and 135 in the Regular Bupivacaine group. | Posted | Mean | Standard Deviation | units on a scale | postoperative day 3 |
|
|
|
|
| Secondary | Overall Opioid Use | The total amount in mg of opioid medication consumed through 12, 24, 36, 48, 60, and 72 hours after surgery will be assessed. | Not Posted | Over the first 72 hours after surgery | Participants |
| Secondary | Mean Length of Hospital Stay | Indirect outcome measure to assess the adequacy of postoperative pain control as an indicator of improvement in healing period, patient participation in physical therapy and faster patient mobilization, and overall health care cost | Not Posted | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Participants |
| Secondary | Change From Baseline in Quality of Life | The impact of pain on patient's quality of life will be assessed through a brief pain inventory (BPI). In addition, the 5-point scale analgesia satisfaction survey will be used along with the BPI to assess patient satisfaction and quality of life. | Not Posted | Will be assessed preoperatively, on the first post-op day (POD 1), on POD2, and POD 3 | Participants |
| Secondary | Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours | Not Posted | 72 hours after surgery | Participants |
| Secondary | Hospital Cost for Patient Care During Hospitalization | Hospital cost for patient care during hospitalization will be estimated from hospital charges and financial records. | Not Posted | duration of hospital stay, an expected average of 4 weeks | Participants |
| 4 |
| 171 |
| 0 |
| 171 |
| 0 |
| 171 |
| EG001 | Regular Bupivacaine | Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension. Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure. Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day | 2 | 175 | 0 | 175 | 0 | 175 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|