Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies

Mayo Clinic105 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

105

Conditions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Benefit of Analgesia Score (OBAS)

The Overall Benefit of Analgesia Score (OBAS) is a multi-dimensional survey that measures a patient's benefit from postoperative pain therapy. It assesses pain intensity, opioid-related adverse events, and patient satisfaction with analgesia. Each of 7 questions are scored on a scale from 0 to 4 where 0=minimal/not at all and 4=maximum/very much. The total score is a sum of the 7 item scores with question 7 scored as 4 minus the patient reported number. Total scores range from 0 to 28 with lower scores representing greater benefit from analgesic therapy. The median total OBAS score for each group is presented.