NCT02740114

Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway

Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway: A Single-Blinded, Randomized, Controlled Study

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Bupivacaine is a drug that is traditionally given as an injection to numb surgical sites. Liposomes are molecules that are similar to fats. Sometimes drugs are combined with liposomes to make them able to stay in the body for longer periods of time. This has been done with bupivacaine to create liposomal bupivacaine. The goal of this clinical research study is to compare the effects of bupivacaine to those of liposomal bupivacaine when given to patients who are having gynecologic surgery. Researchers want to compare how long the drugs work to numb the wound and how long patients take to recover from surgery.

Detailed description

Study Arms and Drug Administration: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study arms: * If you are in Arm 1, you will receive bupivacaine only. * If you are in Arm 2, you will receive a combination of liposomal bupivacaine and bupivacaine. You will have an equal (50/50) chance of being assigned to either group. You will not know what you are receiving. However, the study staff will know what you are receiving. In both cases, the drug(s) will be injected into your skin and tissue at the end of your surgery, right before the wound is closed. Study Data Collection: Every day while you are in the hospital recovering from surgery, you will be asked questions about pain, any side effects you may be having, symptoms, and opioid use. Within 30 days after you leave the hospital, you may also be called and asked about side effects you may be having. If you are called, this call should last about 10-15 minutes. This information may also be collected during a routinely scheduled clinic visit and from the medical record. Three (3) and 7 days after you leave the hospital, and then 1 time every week after that for a total of 8 weeks, you will be called or emailed and asked questions about any symptoms you may be having. If you are called, each call should last about 10-15 minutes. If you are also enrolled on the study BS99-094 "Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System," information from your participation in this study may also be collected and used in that study. Length of Study: Your participation on this study will be over 8 weeks after you leave the hospital. This is an investigational study. Both bupivacaine and liposomal bupivacaine are FDA approved and commercially available. It is investigational to compare the 2 drugs. Up to 200 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

• Malignant Neoplasms of Female Genital Organs
• Gynecologic Cancer

Interventions

Type	Name	Description
DRUG	Bupivacaine	150 mg (0.25%) injected on each side of the wound at the end of surgery before wound closure.
DRUG	Liposomal Bupivacaine	266 mg injected on each side of the wound at the end of surgery before wound closure.
DRUG	Oxycodone	1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.
BEHAVIORAL	Pill Diary	Participants complete a pill diary every day for 30 days after hospital discharge.
BEHAVIORAL	Symptom Questionnaire	Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.

Timeline

• Start date: 2016-08-31
• Primary completion: 2020-07-23
• Completion: 2020-07-23
• First posted: 2016-04-15
• Last updated: 2021-10-18
• Results posted: 2021-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study