Clinical trial NCT04258631: Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies
Official title: Wound Infiltration With Liposomal Bupivacaine With or Without Intrathecal Analgesia in Laparotomy for Gynecological Malignancy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malignant Female Reproductive System Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This phase IV trial studies how well liposomal bupivacaine with or without hydromorphone works in improving pain control during the first 24 hours after surgery in patients with gynecological malignancies undergoing laparotomy. Liposomal bupivacaine is routinely infiltrated into the skin surrounding the abdominal incision, and is effective in providing good relief of incisional pain. Hydromorphone is also a type of pain medication that may provide better management of deep abdominal pain. It is not yet known if giving liposomal bupivacaine with or without hydromorphone will work better in improving pain in patients with gynecological malignancies during the first 24 hours after surgery.

Detailed description: PRIMARY OBJECTIVES:

I. Evaluate if no additional intervention is noninferior to intrathecal analgesia (ITA) for postoperative pain experience 24 hours after surgery after laparotomy for gynecological malignancy within an established enhanced recovery pathway which includes incisional liposomal bupivacaine (ILB).

II. Evaluate the effect of intrathecal analgesia on patient satisfaction with postoperative analgesia after laparotomy for gynecological malignancy.

III. Report the impact of ITA use on cost. IV. Validate the Quality of Recovery (QOR)-15 in our population.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo standard of care laparotomy and then receive liposomal bupivacaine.

ARM II: Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone intrathecally (IT).

Eligibility criteria: Inclusion Criteria:

* Elective surgery for suspected (based on consulting surgeon's opinion-imaging, laboratory \[lab\], pathology \[path\]) gynecological malignancy, enhanced recovery after surgery (ERAS) protocol

Exclusion Criteria:

* Inability to read or understand English
* Prehospitalization narcotic use if weekly average daily oral morphine equivalent of \> 20 mg
* Chronic pain syndromes such as fibromyalgia
* Extensive surgery planned (surrogate for post-operative \[postop\] pain): Planned intensive care unit (ICU) admission, abdominoperineal resection, exenteration, use of intraoperative radiation (IORT), hyperthermic intraperitoneal chemotherapy (HIPEC)
* Contraindication to neuraxial analgesia:

  * Coagulopathy

    * International normalized ratio (INR) \> 1.2 current or predicted after surgery (e.g. planned right hepatic resection)
    * Thrombocytopenia. Platelets (plts) \< 100
    * Hemophiliac disease states (hemophilia, von Willebrand disease, etc.)
    * Patients receiving antithrombotic or thrombolytic therapy are excluded according to the American Society of Regional Anesthesia and Pain Medicine (ASRA) guidelines
  * Localized infection at the potential site of injection
  * Significant developmental or structural spinal abnormalities that would preclude a safe spinal technique. These include spina bifida, tethered spinal cord, lumbar spinal fusion, and active lumbar radiculopathy
* Patients with stage 4 or 5 kidney disease (glomerular filtration rate \[GFR\] less than 30 ml/min per 1.73 m\^2)
* Intolerance or allergy to opioids, acetaminophen, or amide-type local anesthetics
* Current pregnancy

Primary outcomes:
measure: Overall Benefit of Analgesia Score (OBAS)
timeFrame: Up to 24 hours after surgery
Secondary outcomes:
measure: Cumulative 24-hour Narcotic Consumption
timeFrame: Up to 24 hours after surgery
measure: Post-operative Pain Scores
timeFrame: Up to 24 hours after surgery
measure: Time to First Analgesic Request
timeFrame: Up to 24 hours after surgery
measure: Use of Intravenous (IV) Patient-controlled Analgesia
timeFrame: Up to 24 hours after surgery
measure: Use of Intravenous Rescue Opioids
timeFrame: Up to 24 hours after surgery
measure: Length of Stay
timeFrame: Up to 1 week after surgery
measure: Additional Fluid Requirement After 24 Hours of Surgery
timeFrame: Up to 24 hours after surgery
measure: Weight Gain Following Surgery
timeFrame: Up to 24 hours after surgery
measure: Total Cost of Care
timeFrame: Entire hospitalization, approximately 2-5 days
measure: Incidence of Adverse Events
timeFrame: Up to 24 hours after surgery
measure: Operating Room Time
timeFrame: Approximately 8 hours
measure: Surgical Time
timeFrame: Approximately 8 hours
measure: Pain Management
timeFrame: Whole hospitalization, approximately 2-5 days
Other outcomes:
measure: Quality of Recovery-15 (QoR-15) Total Score
timeFrame: At 24 hours after surgery
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sean C Dowdy
role: PRINCIPAL_INVESTIGATOR
References: