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

NCT02740114 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2015-1119NCI-2016-00739
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Neoplasms of Female Genital Organs; Gynecologic Cancer

Keywords

Malignant neoplasms of female genital organs; Open gynecologic surgery; Local wound infiltration; Gynecologic cancer; Bupivacaine; Liposomal Bupivacaine; Oxycodone; ETH-Oxydose [DSC]; OxyContin; OxyIR; Roxicodone; Questionnaires; Surveys; MD Anderson Symptom Inventory; MDASI; Pill diary; Medication log

Outcome Measures

Primary Outcomes (1)

• Participants Opioid-Free After Gynecologic Surgery for 48 Hours

  Treatment arms compared with respect to the proportion of patients opioid-free at 48 hours using the Cochran-Mantel-Haenszel test stratified by surgeon.

  48 hours

Secondary Outcomes (2)

• Participants Opioid-Free After Gynecologic Surgery

  8 weeks

• Symptom Scores

  Days 0, 2 and 4 postoperatively, up to 8 weeks

Study Arms (2)

Bupivacaine Group

ACTIVE COMPARATOR

Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain. Participants complete a pill diary every day for 30 days after hospital discharge. 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.

Drug: Bupivacaine; Drug: Oxycodone; Behavioral: Pill Diary; Behavioral: Symptom Questionnaire

Liposomal Bupivacaine + Bupivacaine Group

EXPERIMENTAL

Local wound infiltration with Liposomal Bupivacaine and 0.25% Bupivacaine admixed immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain. Participants complete a pill diary every day for 30 days after hospital discharge. 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.

Drug: Bupivacaine; Drug: Liposomal Bupivacaine; Drug: Oxycodone; Behavioral: Pill Diary; Behavioral: Symptom Questionnaire

Interventions

Bupivacaine DRUG

150 mg (0.25%) injected on each side of the wound at the end of surgery before wound closure.

Bupivacaine Group; Liposomal Bupivacaine + Bupivacaine Group

Liposomal Bupivacaine DRUG

266 mg injected on each side of the wound at the end of surgery before wound closure.

Liposomal Bupivacaine + Bupivacaine Group

Oxycodone DRUG

1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.

Also known as: ETH-Oxydose [DSC], OxyContin, OxyIR, Roxicodone

Bupivacaine Group; Liposomal Bupivacaine + Bupivacaine Group

Pill Diary BEHAVIORAL

Participants complete a pill diary every day for 30 days after hospital discharge.

Also known as: Medication log

Bupivacaine Group; Liposomal Bupivacaine + Bupivacaine Group

Symptom Questionnaire BEHAVIORAL

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.

Also known as: Survey, MD Anderson Symptom Inventory, MDASI

Bupivacaine Group; Liposomal Bupivacaine + Bupivacaine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes metastatic disease from neoplasia originating in other organs
• Planned participation in the Gynecologic Enhanced Recovery Pathway
• Female 18 years of age or older
• Patient must be able to read and speak English
• Consents to being part of a randomized, single-blinded study
• Patient has physical and mental capabilities to take part in study
• Bilirubin less than or equal to 1.5 x upper limit of the normal range (ULN); Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) \</=2.5 x ULN
• If the patient is of childbearing potential, the patient must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study

You may not qualify if:

• Sensitivity to amide-type local anesthetics
• Patients on long-acting opioid medications, or scheduled (four or more times a day for seven or more days) short-acting opioid medications within the last 30 days
• Emergency surgery of any type that does not allow for proper time for protocol review by the patient
• Surgery that involves known/anticipated resection of anterior abdominal wall with plastic surgery reconstruction
• Patients undergoing pelvic exenteration
• Patients undergoing known/anticipated anterior abdominal wall hernia repairs
• Patients weighing \<50 kg

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Meyer LA, Corzo C, Iniesta MD, Munsell M, Shi Q, Pitcher B, Lasala J, Cain KE, Wang XS, Mena G, Ramirez PT. A prospective randomized trial comparing liposomal bupivacaine vs standard bupivacaine wound infiltration in open gynecologic surgery on an enhanced recovery pathway. Am J Obstet Gynecol. 2021 Jan;224(1):70.e1-70.e11. doi: 10.1016/j.ajog.2020.07.017. Epub 2020 Jul 16.

  PMID: 32682856 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Bupivacaine; Oxycodone; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Pedro Ramirez, MD /Professor, Gyn Onc & Reproductive Med
• Organization: UT MD Anderson Cancer Center

peramire@mdanderson.org

713-745-5498

Study Officials

• Pedro Ramirez, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 15, 2016
• Study Start: August 31, 2016
• Primary Completion: July 23, 2020
• Study Completion: July 23, 2020
• Last Updated: October 18, 2021
• Results First Posted: September 22, 2021

Record last verified: 2021-09

Locations

US (1)