Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery
- Conditions
- AnalgesiaSurgery
- Interventions
- Other: Thoracic epidural analgesia (bupivacaine)
- Registration Number
- NCT04117074
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 106
- Individuals ≥ 18 years of age
- Planned laparotomy by the gynecologic oncology service at the sponsor institution.
- Individuals who have a contraindication to thoracic epidural analgesia
- Individuals with a coagulation disorder
- Individuals with an infection at the site of epidural placement
- Individuals with intracranial pathology such as non-communicating increased intracranial pressure or obstruction of cerebrospinal fluid flow related to mass lesions
- Individuals with spinal pathology: abnormal spine anatomy, surgical fusion, or spinal column lesions
- Individuals who have a contraindication to liposomal bupivacaine
- Individuals with a known allergic reaction to liposomal bupivacaine
- Individuals with Childs-Pugh Class B or C liver disease
- Individuals who have a history of long-term opioid use for chronic pain, defined as use of opioid pain medications for ≥4 weeks prior to surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: Surgical Site Infiltration with Liposomal Bupivacaine 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. Arm 1: Thoracic Epidural Analgesia with bupivicaine Thoracic epidural analgesia (bupivacaine) 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.
- Primary Outcome Measures
Name Time Method Analgesia as assessed by pain intensity scores on a visual analog scale 0 to 48 hours postoperatively Pain intensity will be measured using visual analog scale (VAS) pain intensity scores. The VAS scores pain intensity on a scale of 0-10, where 0 is no pain and 10 is the most severe pain.
Total opioid consumption 0 to 48 hours postoperatively Total opioid consumption in IV mg morphine equivalents from 0 to 48 hours postoperatively will be compared between the two arms.
- Secondary Outcome Measures
Name Time Method Amount of Vasopressor required Start of operation through hospital discharge, up to 1 year Total amount (micrograms) of vasopressor required.
Change in Patient-perceived quality of recovery as assessed by the Quality of Recovery-15 instrument (QoR-15) Days 1 through 7 post-intervention Mean patient-perceived quality of recovery scores using the Quality of Recovery-15 instrument (QoR-15) on postoperative days 1 to 7 will be compared between the two arms. The QoR-15 is a validated instrument designed to measure the major domains of postoperative recovery including functional independence, physical comfort/pain, psychological/emotional well-being, cognition and satisfaction with a score of 0 indicating the poorest patient-perceived quality of recovery and 150 indicating the highest patient-perceived quality of recovery.
Duration of Vasopressor administration Start of operation through hospital discharge, up to 1 year Duration (minutes) of vasopressor administration.
Post-discharge narcotic utilization Postoperative day 14 Patient reported total outpatient narcotic use in IV morphine (mg) equivalents on nurse phone survey administered on postoperative day 14.
Change in Serum adrenocorticotropic hormone (ACTH) Baseline and postoperative day 7 Serum ACTH level in pg/mL.
Change in Epinephrine level (pg/mL) Baseline and postoperative day 7 Change in Total cortisol level (microgram/dL) Baseline and postoperative day 7 Change in C-reactive protein level (ng/mL) Baseline and postoperative day 7 Mobility as assessed by the Johns Hopkins Highest Level of Mobility (JH-HLM) scale Up to 7 days post-intervention The Johns Hopkins Highest Level of Mobility scale is an ordinal scale from 1 to 8, with numbers representing mobility milestones that patients accomplish, based on observation. Patients who score a 2 have some type of bed mobility, while those scoring an 8 can walk more than 250 feet.
Degree of sedation as assessed by the Pasero Opioid-Induced Sedation Scale Up to 7 days post-intervention 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.
Change in Anti-diuretic hormone (ADH) level Baseline and postoperative day 7 ADH level in pg/mL.
Change in Glycosaminoglycans level (ng/mL) Baseline and postoperative day 7 Change in Tumor necrosis factor alpha (TNF-α) level Baseline and postoperative day 7 TNF-α level in pg/mL.
Change in Salivary cortisol (microgram/dL) level Baseline and postoperative day 7 Total intravenous fluids administered in mL Arrival in recovery through hospital discharge, up to 1 year Change in Interleukin-6 level (pg/mL) Baseline and postoperative day 7 Change in Atrial natriuretic peptide (ANP) level Baseline and postoperative day 7 ANP level in pg/mL.
Change in Syndecan-1 level (pg/mL) Baseline and postoperative day 7 Change in Endothelial glycocalyx constituents (ng/mL) Baseline and postoperative day 7 Time (days) to return of bowel function (ROBF) Up to 7 days post-intervention 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.
Number of participants with postoperative ileus Up to 7 days post-intervention 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.
Length of stay Up to 1 year The duration of the index inpatient postoperative admission in days.
Time to postoperative diuresis Arrival in recovery through hospital discharge, up to 1 year 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.
Number of postoperative complications Day of admission through postoperative day 30 Number of postoperative complications (Maryland Hospital Acquired Conditions).
Total direct cost of TEA placement and LB surgical site infiltration Up to 1 year Pharmacy and equipment costs, professional fees and the dollar-value of total OR time required for administration of each intervention will be compared.
Rate of 30-day hospital readmission Up to 30 days post discharge from index admission Rate of 30-day hospital readmission assessed as the number of participants who get readmitted within 30 days of discharge from the initial admission.
Trial Locations
- Locations (1)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States