Clinical trial NCT04117074: Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery
Official title: A Non-Inferiority Randomized Trial Comparing the Impact of Thoracic Epidural Analgesia Versus Surgical Site Infiltration With Liposomal Bupivicaine on the Postoperative Recovery of Patients Following Open Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgery
Analgesia
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2019-10-07
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Individuals ≥ 18 years of age
* Planned laparotomy by the gynecologic oncology service at the sponsor institution.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Analgesia as assessed by pain intensity scores on a visual analog scale
timeFrame: 0 to 48 hours postoperatively
measure: Total opioid consumption
timeFrame: 0 to 48 hours postoperatively
Secondary outcomes:
measure: Change in Patient-perceived quality of recovery as assessed by the Quality of Recovery-15 instrument (QoR-15)
timeFrame: Days 1 through 7 post-intervention
measure: Time (days) to return of bowel function (ROBF)
timeFrame: Up to 7 days post-intervention
measure: Number of participants with postoperative ileus
timeFrame: Up to 7 days post-intervention
measure: Mobility as assessed by the Johns Hopkins Highest Level of Mobility (JH-HLM) scale
timeFrame: Up to 7 days post-intervention
measure: Degree of sedation as assessed by the Pasero Opioid-Induced Sedation Scale
timeFrame: Up to 7 days post-intervention
measure: Length of stay
timeFrame: Up to 1 year
measure: Time to postoperative diuresis
timeFrame: Arrival in recovery through hospital discharge, up to 1 year
measure: Total intravenous fluids administered in mL
timeFrame: Arrival in recovery through hospital discharge, up to 1 year
measure: Amount of Vasopressor required
timeFrame: Start of operation through hospital discharge, up to 1 year
measure: Duration of Vasopressor administration
timeFrame: Start of operation through hospital discharge, up to 1 year
measure: Number of postoperative complications
timeFrame: Day of admission through postoperative day 30
measure: Total direct cost of TEA placement and LB surgical site infiltration
timeFrame: Up to 1 year
measure: Post-discharge narcotic utilization
timeFrame: Postoperative day 14
measure: Change in Serum adrenocorticotropic hormone (ACTH)
timeFrame: Baseline and postoperative day 7
measure: Change in Epinephrine level (pg/mL)
timeFrame: Baseline and postoperative day 7
measure: Change in Total cortisol level (microgram/dL)
timeFrame: Baseline and postoperative day 7
measure: Change in Anti-diuretic hormone (ADH) level
timeFrame: Baseline and postoperative day 7
measure: Change in Interleukin-6 level (pg/mL)
timeFrame: Baseline and postoperative day 7
measure: Change in Atrial natriuretic peptide (ANP) level
timeFrame: Baseline and postoperative day 7
measure: Change in Syndecan-1 level (pg/mL)
timeFrame: Baseline and postoperative day 7
measure: Change in Glycosaminoglycans level (ng/mL)
timeFrame: Baseline and postoperative day 7
measure: Change in Endothelial glycocalyx constituents (ng/mL)
timeFrame: Baseline and postoperative day 7
measure: Change in C-reactive protein level (ng/mL)
timeFrame: Baseline and postoperative day 7
measure: Change in Tumor necrosis factor alpha (TNF-α) level
timeFrame: Baseline and postoperative day 7
measure: Change in Salivary cortisol (microgram/dL) level
timeFrame: Baseline and postoperative day 7
measure: Rate of 30-day hospital readmission
timeFrame: Up to 30 days post discharge from index admission
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Rebecca L Stone, MD
role: PRINCIPAL_INVESTIGATOR
References: