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

NCT04117074 | Completed Phase 3 FDA Drug

• 2 other identifiers: J17157IRB00223229
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Analgesia as assessed by pain intensity scores on a visual analog scale

  Pain intensity will be measured using visual analog scale (VAS) pain intensity scores. The VAS scores pain intensity on a scale of 0-10, where 0 is no pain and 10 is the most severe pain.

  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.

  0 to 48 hours postoperatively

Secondary Outcomes (26)

• Change in Patient-perceived quality of recovery as assessed by the Quality of Recovery-15 instrument (QoR-15)

  Days 1 through 7 post-intervention

• Time (days) to return of bowel function (ROBF)

  Up to 7 days post-intervention

• Number of participants with postoperative ileus

  Up to 7 days post-intervention

• Mobility as assessed by the Johns Hopkins Highest Level of Mobility (JH-HLM) scale

  Up to 7 days post-intervention

• Degree of sedation as assessed by the Pasero Opioid-Induced Sedation Scale

  Up to 7 days post-intervention

Study Arms (2)

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.

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.

Drug: Liposomal bupivacaine

Interventions

Liposomal bupivacaine DRUG

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

Also known as: Exparel

Arm 2: Surgical Site Infiltration with Liposomal Bupivacaine

Thoracic epidural analgesia (bupivacaine) OTHER

Perioperative bupivacaine based thoracic epidural placed preoperatively.

Arm 1: Thoracic Epidural Analgesia with bupivicaine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Tea; Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Rebecca L Stone, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: April 14, 2021
• Primary Completion: March 3, 2025
• Study Completion: March 17, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)