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Insufficient funding to continue with study activities
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| Name | Class |
|---|---|
| Pacira Pharmaceuticals, Inc | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| VAS Pain Score at 24, 48, and 72 Hours Post-surgery Completion |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Cornella | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Phoenix | Arizona | 85054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18830553 | Background | 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. | |
| 26204387 | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Bupivacaine | 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. 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. |
| FG001 | Liposomal Bupivacaine | 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 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Bupivacaine | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Post-surgical Opioid Medication Use | Participants post-surgical analgesic medication use of IV hydrocodone and oxycodone measured in morphine equivalents (ME) | Posted | Median | Full Range | Morphine Equivalents (ME) | First 72 hours following surgery completion |
|
Adverse events were collected post operative on all participants, approximately 7 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Bupivacaine | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Johnny Yi | Mayo Clinic | 480-342-0612 | Yi.Johnny@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2019 | Sep 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Patients will be randomized to receive either the bupivacaine HCl injection at the time of surgery or bupivacaine HCl plus liposomal bupivacaine.
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This will be a blinded study where investigators, patients, and care providers will be blinded to treatment assignment.
|
| 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. |
|
Scale Ranges from 0 (no pain) to 10 (extreme pain)
| 24, 48, and 72 hours post-surgery completion |
| Nausea at 24, 48, and 72 Hours Post-surgery Completion | Number of times patient reported feeling nauseous | 24, 48, and 72 hours post-surgery |
| Emesis at 24, 48, and 72 Hours Post-surgery Completion | Number of times the patient vomited | 24, 48, and 72 hours post-surgery |
| 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 |
| 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 |
| 22570563 | 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. |
| 26056753 | 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. |
| 28802777 | 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. |
| 23969801 | 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. |
| BG001 | Liposomal Bupivacaine | 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 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Liposomal Bupivacaine |
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 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. |
|
|
|
| Primary | Total Post-surgical Analgesic Medication Use | Participants post-surgical analgesic medication use of Ibuprofen and acetaminophen measured in milligrams (mg) | Posted | Median | Full Range | 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) | Data not collected or analyzed | Posted | 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) | Posted | Median | Full Range | score on a scale | 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 | Posted | Median | Full Range | events | 24, 48, and 72 hours post-surgery |
|
|
|
|
| Secondary | Emesis at 24, 48, and 72 Hours Post-surgery Completion | Number of times the patient vomited | Posted | Median | Full Range | events | 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 | Posted | Count of Participants | Participants | 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) | Posted | Median | Full Range | score on a scale | 72 hours and 7-10 days post surgery |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 3 |
| 14 |
| EG001 | Liposomal Bupivacaine | 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 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. | 0 | 14 | 0 | 14 | 2 | 14 |
| Urinary Incontinence | Renal and urinary disorders | Systematic Assessment |
|
| Protruding sutures | Surgical and medical procedures | Systematic Assessment |
|
Not provided
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| D000588 |
| Amines |
| Wilcoxon (Mann-Whitney) |
| 1.000 |
| Superiority |
| 72 hours post-surgery |
|
| Wilcoxon (Mann-Whitney) |
| 0.490 |
| Superiority |
| Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 72 hours post-surgery | Wilcoxon (Mann-Whitney) | 0.564 | Superiority |
| 72 hours post-surgery |
|
| Wilcoxon (Mann-Whitney) |
| 0.970 |
| Superiority |
| Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 72 hours post-surgery | Wilcoxon (Mann-Whitney) | 0.536 | Superiority |
| 72 hours post-surgery |
|
| Wilcoxon (Mann-Whitney) |
| 0.353 |
| Superiority |
| Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 72 hours post-surgery | Wilcoxon (Mann-Whitney) | 0.165 | Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.656 |
| Superiority |