The goal of this study is to test the hypothesis that surgical site infiltration with liposomal bupivacaine (LB) is non-inferior to and more cost effective than thoracic epidural analgesia (TEA) for patients undergoing open gynecologic surgery on an established enhanced recovery program (ERP) using a non-inferiority randomized trial design. The impact of TEA and surgical site infiltration with LB on neuroendocrine and inflammatory mediators of surgical stress response (SSR) will also be investigated as a translational endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure.
Perioperative bupivacaine based thoracic epidural placed preoperatively.
Johns Hopkins Hospital
Baltimore, Maryland, United States
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.
Time frame: 0 to 48 hours postoperatively
Total Opioid Consumption
Total opioid consumption in IV mg morphine equivalents from 0 to 48 hours postoperatively will be compared between the two arms.
Time frame: 0 to 48 hours postoperatively
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.
Time frame: Days 1 through 7 post-intervention
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.
Time frame: Up to 7 days post-intervention
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.
Time frame: Up to 7 days post-intervention
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.
Time frame: Up to 7 days post-intervention
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.
Time frame: Up to 7 days post-intervention
Length of Stay
The duration of the index inpatient postoperative admission in days.
Time frame: Up to 1 year
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.
Time frame: Arrival in recovery through hospital discharge, up to 1 year
Total Intravenous Fluids Administered in mL
Total intravenous fluids administered in mL.
Time frame: Arrival in recovery through hospital discharge, up to 1 year
Amount of Vasopressor Required
Total amount (micrograms) of Levophed required.
Time frame: Start of operation through hospital discharge, up to 1 year
Duration of Vasopressor Administration
Duration (minutes) of vasopressor administration.
Time frame: Start of operation through hospital discharge, up to 1 year
Number Participants With Postoperative Complications
Number of participants with postoperative complications (Maryland Hospital Acquired Conditions).
Time frame: Day of admission through postoperative day 30
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)
Time frame: Up to 1 year
Post-discharge Narcotic Utilization
Patient reported total outpatient narcotic use in IV morphine (mg) equivalents on nurse phone survey administered on postoperative day 14.
Time frame: Postoperative day 14
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.
Time frame: Up to 30 days post discharge from index admission
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