SurgeryPhase 3NCT04117074
Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery
A Phase 3 study testing Liposomal bupivacaine and Thoracic epidural analgesia (bupivacaine) in people with Surgery and Analgesia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Liposomal bupivacaine and Thoracic epidural analgesia (bupivacaine)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2021to 17 Mar 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals ≥ 18 years of age
- Planned laparotomy by the gynecologic oncology service at the sponsor institution.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Liposomal bupivacaine, Thoracic epidural analgesia (bupivacaine)
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Exparel
Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure.
Thoracic epidural analgesia (bupivacaine)Other
Perioperative bupivacaine based thoracic epidural placed preoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Thoracic Epidural Analgesia with bupivicaine | Experimental | 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. Receives: Other: Thoracic epidural analgesia (bupivacaine) |
| Arm 2: Surgical Site Infiltration with Liposomal Bupivacaine | Experimental | 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. Receives: Drug: Liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0 to 48 hours postoperatively
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 7 days post-intervention
Length of Stay
The duration of the index inpatient postoperative admission in days.
Measured: 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.
Measured: Arrival in recovery through hospital discharge, up to 1 year
Total Intravenous Fluids Administered in mL
Total intravenous fluids administered in mL.
Measured: Arrival in recovery through hospital discharge, up to 1 year
Amount of Vasopressor Required
Total amount (micrograms) of Levophed required.
Measured: Start of operation through hospital discharge, up to 1 year
Duration of Vasopressor Administration
Duration (minutes) of vasopressor administration.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Up to 30 days post discharge from index admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start14 Apr 2021
- Primary completion3 Mar 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Sponsor
- Investigators
- Rebecca L Stone, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117074
- Sponsor's protocol ID
- J17157
- Other IDs
- IRB00223229
- Status last verified
- Apr 2026
- First submitted
- 3 Oct 2019
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04117074
- Acronym / sponsor ID
- J17157
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Posted 19 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Thoracic Epidural Analgesia with bupivicaine | Experimental | Other: 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. |
| Arm 2: Surgical Site Infiltration with Liposomal Bupivacaine | Experimental | Drug: Liposomal bupivacaineLiposomal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals ≥ 18 years of age
- Planned laparotomy by the gynecologic oncology service at the sponsor institution.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaineAlso: ExparelSurgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. | Drug | Arm 2: Surgical Site Infiltration with Liposomal Bupivacaine |
| Thoracic epidural analgesia (bupivacaine)Perioperative bupivacaine based thoracic epidural placed preoperatively. | Other | Arm 1: Thoracic Epidural Analgesia with bupivicaine |
Primary outcome
Analgesia Assessed by the Area Under the Curve of Visual Analog Scale Pain Intensity Scores
Time frame: 0 to 48 hours postoperatively
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.
Total Opioid Consumption
Time frame: 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.
14 secondary outcomes
Patient-perceived Quality of Recovery as Assessed by the Quality of Recovery-15 Instrument (QoR-15)
Time frame: Days 1 through 7 post-intervention
Time (Days) to Return of Bowel Function (ROBF)
Time frame: Up to 7 days post-intervention
Number of Participants With Postoperative Ileus
Time frame: Up to 7 days post-intervention
Mobility as Assessed by the Johns Hopkins Highest Level of Mobility (JH-HLM) Scale
Time frame: Up to 7 days post-intervention
Number of Participants With Sedation Score ≥2 as Assessed by the Pasero Opioid-Induced Sedation Scale
Time frame: Up to 7 days post-intervention
Length of Stay
Time frame: Up to 1 year
Time to Postoperative Diuresis
Time frame: Arrival in recovery through hospital discharge, up to 1 year
Total Intravenous Fluids Administered in mL
Time frame: Arrival in recovery through hospital discharge, up to 1 year
Amount of Vasopressor Required
Time frame: Start of operation through hospital discharge, up to 1 year
Duration of Vasopressor Administration
Time frame: Start of operation through hospital discharge, up to 1 year
Number Participants With Postoperative Complications
Time frame: Day of admission through postoperative day 30
Total Direct Cost of TEA Placement and LB Surgical Site Infiltration
Time frame: Up to 1 year
Post-discharge Narcotic Utilization
Time frame: Postoperative day 14
Number of Participants With 30-day Hospital Readmission
Time frame: Up to 30 days post discharge from index admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca L Stone, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liposomal bupivacaine and Thoracic epidural analgesia (bupivacaine) in people with Surgery and Analgesia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia Assessed by the Area Under the Curve of Visual Analog Scale Pain Intensity Scores (time frame: 0 to 48 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.