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NCT Number: NCT04258631

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

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.

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Key information

Conditions

Malignant Female Reproductive System Neoplasm

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydromorphone

Drug

Given IT

Other names: (-)-Hydromorphone, Dihydromorphinone, Hydromorphon

Laparotomy

Procedure

Undergo laparotomy

Liposomal bupivacaine

Drug

Drug

Other names: Bupivacaine Liposome Injectable Suspension, Exparel

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Overall Benefit of Analgesia Score (OBAS)

    Time frame: Up to 24 hours after surgery

    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.

Secondary outcomes

  1. Cumulative 24-hour Narcotic Consumption

    Time frame: Up to 24 hours after surgery

    Various narcotic medications are standardized and reported as Morphine Milligram Equivalents (MME).

  2. Post-operative Pain Scores

    Time frame: Up to 24 hours after surgery

    Postoperative pain is scored on a scale of 0 - 10, with the lower score showing a better outcome.

  3. Time to First Analgesic Request

    Time frame: Up to 24 hours after surgery

    Amount of time from leaving surgery to the first request for pain relief.

  4. Use of Intravenous (IV) Patient-controlled Analgesia

    Time frame: Up to 24 hours after surgery

    Number of patients that used IV, patient controlled analgesia after surgery.

  5. Use of Intravenous Rescue Opioids

    Time frame: Up to 24 hours after surgery

    Number of patients that needed IV rescue opioids after surgery.

  6. Length of Stay

    Time frame: Up to 1 week after surgery

    Length of associated hospitalization in days.

  7. Additional Fluid Requirement After 24 Hours of Surgery

    Time frame: Up to 24 hours after surgery

    Number of patients requiring additional IV fluids after surgery.

  8. Weight Gain Following Surgery

    Time frame: Up to 24 hours after surgery

    Weight difference post- and pre-surgery.

  9. Total Cost of Care

    Time frame: Entire hospitalization, approximately 2-5 days

    All medical costs occurring during hospitalization.

  10. Incidence of Adverse Events

    Time frame: Up to 24 hours after surgery

    Reported as the number participants reporting one or more adverse events on each study arm.

  11. Operating Room Time

    Time frame: Approximately 8 hours

    Length of time from when the patient entered the operating room to when they left.

  12. Surgical Time

    Time frame: Approximately 8 hours

    Time from first incision to surgical site closure.

  13. Pain Management

    Time frame: Whole hospitalization, approximately 2-5 days

    Pharmaceutical costs associated with pain management.

Other outcomes

  1. Quality of Recovery-15 (QoR-15) Total Score

    Time frame: At 24 hours after surgery

    The Quality of Recovery (QoR-15) questionnaire is a 15-item survey that patients rate to measure the quality of their recovery after surgery. Each item in the questionnaire is graded on an 11-point numeric rating scale with total scores ranging from 15 to 150. Higher scores indicate better recovery.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Wound Infiltration With Liposomal Bupivacaine With or Without Intrathecal Analgesia in Laparotomy for Gynecological Malignancy: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2020
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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