| Primary | Analgesia Assessed by the Area Under the Curve of Visual Analog Scale Pain Intensity Scores | Pain intensity was measured using the Visual Analog Scale (VAS), a 0-10 scale where 0 indicates no pain and 10 indicates worst pain imaginable. VAS scores were assessed hourly from 0 to 48 hours postoperatively. The area under the curve (AUC) was calculated as the sum of hourly VAS scores over 48 hours, yielding a possible range of 0 to 480. Higher scores indicate greater cumulative pain burden and worse outcomes. | | Posted | | Mean | Standard Deviation | VAS score x Hours | | 0 to 48 hours postoperatively | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. Liposomal bupivacaine: Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00087.1± 65.4
- OG00192.8± 69.6
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| Primary | Total Opioid Consumption | Total opioid consumption in IV mg morphine equivalents from 0 to 48 hours postoperatively will be compared between the two arms. | | Posted | | Median | Inter-Quartile Range | Morphine Miligram Equivalents | | 0 to 48 hours postoperatively | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. Liposomal bupivacaine: Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. |
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| Secondary | Patient-perceived Quality of Recovery as Assessed by the Quality of Recovery-15 Instrument (QoR-15) | Mean patient-perceived quality of recovery scores using the Quality of Recovery-15 instrument (QoR-15) on postoperative days 1 to 7 were compared between the two arms. The QoR-15 is a validated instrument designed to measure the major domains of postoperative recovery with a score range of 0 indicating the poorest patient-perceived quality of recovery to 150 indicating the highest patient-perceived quality of recovery. QoR-15 scores were analyzed using a linear mixed-effects model for repeated measures across postoperative days 1-7. The single value reported for each arm represents the model-based estimated marginal mean (least squares mean) across all assessed postoperative days using all available observed data without imputation. This reflects an overall POD1-7 summary rather than a score from a single postoperative day. | Although 49 participants were assigned to arm A, one participant withdrew immediately after surgery and did not provide any QOR-15 data. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on scale | | Days 1 through 7 post-intervention | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. |
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| Secondary | Time (Days) to Return of Bowel Function (ROBF) | Time to ROBF is defined as the time lapse from the day of surgery (DOS) to the day oral intake is consistently tolerated for 48 hours without vomiting. | | Posted | | Median | 95% Confidence Interval | days | | Up to 7 days post-intervention | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. Liposomal bupivacaine: Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. |
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| Secondary | Number of Participants With Postoperative Ileus | Ileus is defined as the occurrence of postoperative nausea and vomiting requiring cessation of oral intake and initiation of intravenous hydration +/- nasogastric tube placement following documented ROBF or the persistence of these symptoms beyond postoperative day 5 in the absence of ROBF. | | Posted | | Count of Participants | | Participants | | Up to 7 days post-intervention | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. Liposomal bupivacaine: Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. |
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| Secondary | Mobility as Assessed by the Johns Hopkins Highest Level of Mobility (JH-HLM) Scale | The Johns Hopkins Highest Level of Mobility (JH-HLM) scale is an ordinal scale ranging from 1 to 8, with higher scores indicating better mobility. Scores represent observed mobility milestones achieved by the patient; a score of 1 indicates lying in bed, while a score of 8 indicates walking 250 feet or more. Mobility was analyzed using a linear mixed-effects model for repeated measures across postoperative days 1-7. The single value reported for each arm represents the model-based estimated marginal mean (least squares mean) across all assessed postoperative days using all available observed data without imputation. This reflects an overall POD1-7 summary rather than a single postoperative day. | | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Up to 7 days post-intervention | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine |
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| Secondary | Number of Participants With Sedation Score ≥2 as Assessed by the Pasero Opioid-Induced Sedation Scale | The Pasero Opioid-induced Sedation Scale (POSS) is a valid, reliable tool used to assess sedation when administering opioid medications to manage pain. It uses an ordinal scale of 1-4 with a POSS of 1 or 2 indicating an acceptable level of sedation and a score of 3 or 4 indicating over-sedation and the need for intervention, such as the administration of a reversal agent in the case of a score of 4. | The number of participants with a sedation score ≥2 at any time from postoperative day 0 through postoperative day 7 was reported. | Posted | | Count of Participants | | Participants | | Up to 7 days post-intervention | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. Liposomal bupivacaine: Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. |
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| Secondary | Length of Stay | The duration of the index inpatient postoperative admission in days. | | Posted | | Median | Inter-Quartile Range | Days | | Up to 1 year | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. Liposomal bupivacaine: Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. |
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| Secondary | Time to Postoperative Diuresis | Time to diuresis is defined as the recovery time in hours to achieve a net negative fluid balance sustained over a 24 hour time period. | | Posted | | Median | Inter-Quartile Range | Hours | | Arrival in recovery through hospital discharge, up to 1 year | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. Liposomal bupivacaine: Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. |
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| Secondary | Total Intravenous Fluids Administered in mL | Total intravenous fluids administered in mL. | | Posted | | Median | Inter-Quartile Range | Milliliters | | Arrival in recovery through hospital discharge, up to 1 year | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. Liposomal bupivacaine: Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. |
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| Secondary | Amount of Vasopressor Required | Total amount (micrograms) of Levophed required. | | Posted | | Median | Inter-Quartile Range | Micrograms | | Start of operation through hospital discharge, up to 1 year | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. Liposomal bupivacaine: Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. |
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| Secondary | Duration of Vasopressor Administration | Duration (minutes) of vasopressor administration. | The analysis population includes only participants who received vasopressors. Participants who did not receive vasopressors were excluded from this analysis. | Posted | | Median | Inter-Quartile Range | Minutes | | Start of operation through hospital discharge, up to 1 year | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. Liposomal bupivacaine: Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. |
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| Secondary | Number Participants With Postoperative Complications | Number of participants with postoperative complications (Maryland Hospital Acquired Conditions). | The denominator reflects the number of participants with available data for this outcome. Participants with missing postoperative complication data were not included in the analysis. In addition, for 30-day outcomes, participants who remained hospitalized at day 30 were not included because these post-discharge outcomes were not applicable. | Posted | | Count of Participants | | Participants | | Day of admission through postoperative day 30 | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. Liposomal bupivacaine: Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. |
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| Secondary | Total Direct Cost of TEA Placement and LB Surgical Site Infiltration | Total Direct Cost (Pharmacy and equipment costs, professional fees and the dollar-value of total OR time required for administration of each intervention) | Participants with collected data. | Posted | | Median | Inter-Quartile Range | U.S. Dollars | | Up to 1 year | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. Liposomal bupivacaine: Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. |
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| Secondary | Post-discharge Narcotic Utilization | Patient reported total outpatient narcotic use in IV morphine (mg) equivalents on nurse phone survey administered on postoperative day 14. | Participants with collected data. | Posted | | Median | Inter-Quartile Range | PO Morphine Milligram Equivalents | | Postoperative day 14 | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. Thoracic epidural analgesia (bupivacaine): Perioperative bupivacaine based thoracic epidural placed preoperatively. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. Liposomal bupivacaine: Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. |
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| Other Pre-specified | Change in Serum Adrenocorticotropic Hormone (ACTH) | Serum ACTH level in pg/mL. | | Not Posted | | | | | | Baseline and postoperative day 7 | | Participants | | | | |
| Other Pre-specified | Change in Epinephrine Level (pg/mL) | | | Not Posted | | | | | | Baseline and postoperative day 7 | | Participants | | | | |
| Other Pre-specified | Change in Total Cortisol Level (Microgram/dL) | | | Not Posted | | | | | | Baseline and postoperative day 7 | | Participants | | | | |
| Other Pre-specified | Change in Anti-diuretic Hormone (ADH) Level | | | Not Posted | | | | | | Baseline and postoperative day 7 | | Participants | | | | |
| Other Pre-specified | Change in Interleukin-6 Level (pg/mL) | | | Not Posted | | | | | | Baseline and postoperative day 7 | | Participants | | | | |
| Other Pre-specified | Change in Syndecan-1 Level (pg/mL) | | | Not Posted | | | | | | Baseline and postoperative day 7 | | Participants | | | | |
| Other Pre-specified | Change in Atrial Natriuretic Peptide (ANP) Level | | | Not Posted | | | | | | Baseline and postoperative day 7 | | Participants | | | | |
| Other Pre-specified | Change in Glycosaminoglycans Level (ng/mL) | | | Not Posted | | | | | | Baseline and postoperative day 7 | | Participants | | | | |
| Other Pre-specified | Change in Endothelial Glycocalyx Constituents (ng/mL) | | | Not Posted | | | | | | Baseline and postoperative day 7 | | Participants | | | | |
| Other Pre-specified | Change in C-reactive Protein Level (ng/mL) | | | Not Posted | | | | | | Baseline and postoperative day 7 | | Participants | | | | |
| Other Pre-specified | Change in Tumor Necrosis Factor Alpha (TNF-α) Level | | | Not Posted | | | | | | Baseline and postoperative day 7 | | Participants | | | | |
| Other Pre-specified | Change in Salivary Cortisol (Microgram/dL) Level | | | Not Posted | | | | | | Baseline and postoperative day 7 | | Participants | | | | |
| Secondary | Number of Participants With 30-day Hospital Readmission | Number of participants with 30-day hospital readmission assessed as the number of participants who get readmitted within 30 days of discharge from the initial admission. | Participants with data collected. | Posted | | Count of Participants | | Participants | | Up to 30 days post discharge from index admission | | | | ID | Title | Description |
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| OG000 | Arm 1: Thoracic Epidural Analgesia With Bupivicaine | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. | | OG001 | Arm 2: Surgical Site Infiltration With Liposomal Bupivacaine | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. |
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