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

Johns Hopkins Medicine

Status and phase: Completed; Phase 3

Conditions: Surgery; Analgesia

Treatments: Other: Thoracic epidural analgesia (bupivacaine); Drug: Liposomal bupivacaine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04117074

IRB00223229 (Other Identifier)

J17157

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Arm 1: Thoracic Epidural Analgesia with bupivicaine

Experimental group

Description:

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.

Treatment:

Other: Thoracic epidural analgesia (bupivacaine)

Arm 2: Surgical Site Infiltration with Liposomal Bupivacaine

Experimental group

Description:

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.

Treatment:

Drug: Liposomal bupivacaine