Phase 3
N=106
Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery
Surgery · Analgesia
Bottom Line
View on ClinicalTrials.gov: NCT04117074 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Analgesia Assessed by the Area Under the Curve of Visual Analog Scale Pain Intensity Scores — 87.1; 92.8 VAS score x Hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Liposomal bupivacaine (Drug); Thoracic epidural analgesia (bupivacaine) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Analgesia Assessed by the Area Under the Curve of Visual Analog Scale Pain Intensity Scores |
87.1; 92.8 | — |
| PRIMARY Total Opioid Consumption |
21.2; 18.8 | — |
| SECONDARY Patient-perceived Quality of Recovery as Assessed by the Quality of Recovery-15 Instrument (QoR-15) |
106.24; 107.46 | — |
| SECONDARY Time (Days) to Return of Bowel Function (ROBF) |
2; 3 | — |
| SECONDARY Number of Participants With Postoperative Ileus |
6; 6 | — |
| SECONDARY Mobility as Assessed by the Johns Hopkins Highest Level of Mobility (JH-HLM) Scale |
7.25; 7.27 | — |
| SECONDARY Number of Participants With Sedation Score ≥2 as Assessed by the Pasero Opioid-Induced Sedation Scale |
1; 3 | — |
| SECONDARY Length of Stay |
4; 4.5 | — |
| SECONDARY Time to Postoperative Diuresis |
48; 41.75 | — |
| SECONDARY Total Intravenous Fluids Administered in mL |
2523; 2379 | — |
| SECONDARY Amount of Vasopressor Required |
540; 890 | — |
| SECONDARY Duration of Vasopressor Administration |
139.5; 219 | — |
| SECONDARY Number Participants With Postoperative Complications |
1; 0; 1; 5; 1; 3 | — |
| SECONDARY Total Direct Cost of TEA Placement and LB Surgical Site Infiltration |
1168.6; 670.5 | — |
| SECONDARY Post-discharge Narcotic Utilization |
22.5; 7.5 | — |
| SECONDARY Number of Participants With 30-day Hospital Readmission |
3; 6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04117074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.