Liposomal Bupivacaine in Vaginal Hysterectomy

NCT03907033 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 15-008413
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effects of preemptive analgesia using liposomal bupivacaine mixed with bupivacaine HCl, versus bupivacaine HCl alone for uterosacral ligament injection in patients undergoing vaginal hysterectomy. We hypothesize that the group receiving a combination of liposomal bupivacaine and bupivacaine HCl will report superior postoperative pain management. Enhancement in pain control should confer a decrease in opioid and other analgesic medication requirements, which may contribute to decreased nausea, vomiting, and higher overall patient satisfaction with pain control.

Conditions

Vaginal Hysterectomy

Outcome Measures

Primary Outcomes (2)

• Total Post-surgical Opioid Medication Use

  Participants post-surgical analgesic medication use of IV hydrocodone and oxycodone measured in morphine equivalents (ME)

  First 72 hours following surgery completion

• Total Post-surgical Analgesic Medication Use

  Participants post-surgical analgesic medication use of Ibuprofen and acetaminophen measured in milligrams (mg)

  First 72 hours following surgery completion

Secondary Outcomes (6)

• Mean PACU Visual Analog Scale (VAS) (0-10) Pain Score

  Assessed while patient in PACU for recovery post-surgery per standard procedure

• VAS Pain Score at 24, 48, and 72 Hours Post-surgery Completion

  24, 48, and 72 hours post-surgery completion

• Nausea at 24, 48, and 72 Hours Post-surgery Completion

  24, 48, and 72 hours post-surgery

• Emesis at 24, 48, and 72 Hours Post-surgery Completion

  24, 48, and 72 hours post-surgery

• Urinary Retention

  At voiding trial prior to discharge from hospital, approximately 72 hours

Study Arms (2)

Standard Bupivacaine

ACTIVE COMPARATOR

Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.

Drug: Bupivacaine Hydrochloride

Liposomal Bupivacaine

EXPERIMENTAL

Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments

Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride

Interventions

Liposomal bupivacaine DRUG

Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.

Also known as: Exparel

Liposomal Bupivacaine

Bupivacaine Hydrochloride DRUG

We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.

Liposomal Bupivacaine; Standard Bupivacaine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Women 18-85 who will be having an outpatient vaginal hysterectomy with or without concurrent prolapse repair surgery at Mayo Clinic Hospital in Arizona

You may not qualify if:

• Known history of hepatic (liver) disease as evidenced by an AST or ALT that is greater than normal values
• Known history of renal (kidney) disease as evidenced by a serum creatinine that is greater than normal values
• Known history of prolonged QT (QTc greater than 500 m/s)
• Opiate tolerance as noted by daily use of greater than 20 mg morphine daily oral equivalents per day for a minimum of 1 month prior to surgery
• Allergy or contraindication to amide local anesthetics, celecoxib, ketorolac, NSAIDs, acetaminophen, gabapentin, sulfa drugs, or ondansetron
• Allergy to both oxycodone and hydromorphone
• Patients with acute gastrointestinal bleed that has occurred less than 6 months prior to study enrollment
• Adults lacking the ability to consent

Sponsors & Collaborators

• Mayo Clinic: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

Related Publications (6)

• Long JB, Eiland RJ, Hentz JG, Mergens PA, Magtibay PM, Kho RM, Magrina JF, Cornella JL. Randomized trial of preemptive local analgesia in vaginal surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):5-10. doi: 10.1007/s00192-008-0716-6. Epub 2008 Oct 2.

  PMID: 18830553 BACKGROUND

• Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.

  PMID: 26204387 BACKGROUND

• Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.

  PMID: 22570563 BACKGROUND

• Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6.

  PMID: 26056753 BACKGROUND

• Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25.

  PMID: 28802777 BACKGROUND

• Kalogera E, Bakkum-Gamez JN, Jankowski CJ, Trabuco E, Lovely JK, Dhanorker S, Grubbs PL, Weaver AL, Haas LR, Borah BJ, Bursiek AA, Walsh MT, Cliby WA, Dowdy SC. Enhanced recovery in gynecologic surgery. Obstet Gynecol. 2013 Aug;122(2 Pt 1):319-328. doi: 10.1097/AOG.0b013e31829aa780.

  PMID: 23969801 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Johnny Yi
• Organization: Mayo Clinic

Yi.Johnny@mayo.edu

480-342-0612

Study Officials

• Jeffrey L Cornella

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This will be a blinded study where investigators, patients, and care providers will be blinded to treatment assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized to receive either the bupivacaine HCl injection at the time of surgery or bupivacaine HCl plus liposomal bupivacaine.

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 8, 2019
• Study Start: September 3, 2019
• Primary Completion: July 23, 2021
• Study Completion: July 23, 2021
• Last Updated: October 15, 2021
• Results First Posted: October 15, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)