Liposomal Bupivacaine in Vaginal Hysterectomy

Vaginal Hysterectomy Clinical Trial

Official title:

Preemptive Local Analgesia With Liposomal Bupivacaine in Vaginal Hysterectomy: A Randomized Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03907033
• Other study ID #: 15-008413
• Status: Terminated
• Phase: Phase 4
• Start date: September 3, 2019
• Est. completion date: July 23, 2021

Study information

• Verified date: September 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Prior to surgery, patients are assigned by chance (like a coin toss) to receive either the bupivacaine HCl injection at the time of surgery or bupivacaine HCl plus liposomal bupivacaine. Patients and the Principal Investigator cannot choose the study group. Patients will have a 50% chance of being assigned to either group; however, regardless of which group they are assigned to, the medical record will show that they received liposomal bupivacaine. The injections will be given in the vaginal area when the patient is under anesthesia.

After surgery, patients will be asked to record their pain, medication use, pain scores and symptoms in a diary for each 12 hour interval up to 72 hours. Someone will also call twice a day during the 72 hours after surgery to ask about pain level and pain medication use.

Patients will also receive a phone call 7-10 days after the surgery to ask about their recovery and pain level.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: July 23, 2021
• Est. primary completion date: July 23, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

INCLUSION CRITERIA

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

EXCLUSION CRITERIA

1. Known history of hepatic (liver) disease as evidenced by an AST or ALT that is greater than normal values

2. Known history of renal (kidney) disease as evidenced by a serum creatinine that is greater than normal values

3. Known history of prolonged QT (QTc greater than 500 m/s)

4. 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

5. Allergy or contraindication to amide local anesthetics, celecoxib, ketorolac, NSAIDs, acetaminophen, gabapentin, sulfa drugs, or ondansetron

6. Allergy to both oxycodone and hydromorphone

7. Patients with acute gastrointestinal bleed that has occurred less than 6 months prior to study enrollment

8. Adults lacking the ability to consent

Related Conditions & MeSH terms

• Vaginal Hysterectomy

Intervention

Drug:
• Liposomal bupivacaine
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.
• Bupivacaine Hydrochloride
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: J Arthroplasty. 2019 Feb;34(2):399-400. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Mean PACU Visual Analog Scale (VAS) (0-10) Pain Score	Scale Ranges from 0 (no pain) to 10 (extreme pain)	Assessed while patient in PACU for recovery post-surgery per standard procedure
Secondary	VAS Pain Score at 24, 48, and 72 Hours Post-surgery Completion	Scale Ranges from 0 (no pain) to 10 (extreme pain)	24, 48, and 72 hours post-surgery completion
Secondary	Nausea at 24, 48, and 72 Hours Post-surgery Completion	Number of times patient reported feeling nauseous	24, 48, and 72 hours post-surgery
Secondary	Emesis at 24, 48, and 72 Hours Post-surgery Completion	Number of times the patient vomited	24, 48, and 72 hours post-surgery
Secondary	Urinary Retention	Number of patients who had post-void residual (PVR) >150cc's at voiding trial prior to discharge	At voiding trial prior to discharge from hospital, approximately 72 hours
Secondary	Patient Satisfaction With Pain Management at 72 Hours and 7-10 Days Post Surgery	Assessed on 0-10 scale (0 being worst level of satisfaction, 10 being best level)	72 hours and 7-10 days post surgery

External Links

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