Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery

NCT ID: NCT04117074

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-14
• Study Completion Date: 2025-03-17

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.

Conditions

Surgery; Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Thoracic Epidural Analgesia with bupivicaine

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.

Group Type: EXPERIMENTAL

Thoracic epidural analgesia (bupivacaine)

Intervention Type: OTHER

Perioperative bupivacaine based thoracic epidural placed preoperatively.

Arm 2: Surgical Site Infiltration with 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.

Group Type: EXPERIMENTAL

Liposomal bupivacaine

Intervention Type: DRUG

Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure.

Interventions

Liposomal bupivacaine

Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure.

Intervention Type: DRUG

Thoracic epidural analgesia (bupivacaine)

Perioperative bupivacaine based thoracic epidural placed preoperatively.

Intervention Type: OTHER

Other Intervention Names

Exparel

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca L Stone, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00223229

Identifier Type: OTHER

Identifier Source: secondary_id

J17157

Identifier Type: -

Identifier Source: org_study_id