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The investigators are studying ways to improve pain control after surgery. One way to decrease pain is to inject incisions with a numbing medicine (local anesthetic) while in the operating room. There is an FDA approved extended-release version of a commonly used local anesthetic (bupivacaine) that can last for 4 days instead of 6 hours. The investigators are studying whether using the extended-release medication (Exparel) will give better pain relief after laparoscopic and robotic-assisted hysterectomies.
Lidocaine and bupivacaine hydrochloride (HCl) are the most commonly used drugs for wound infiltration during laparoscopic surgery for post-operative pain control. There is some evidence that wound infiltration decreases immediate post-operative pain. While bupivacaine has a slightly slower onset of action (5-10 minutes), it has become the preferred injectable anesthetic for surgical use because of its longer duration of effect (4-8 hours versus 1-2 hours for lidocaine).
DepoFoam bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc., Parsippany, NJ, USA) is a newer extended-release formulation of bupivacaine HCl approved by the U.S. Federal Drug Administration in October 2011. In this suspension, bupivacaine is encapsulated in microscopic spherical lipid-based particles of varying size to allow dispersion of the drug over an extended period of time. Analgesia is prolonged up to 96 hours. Given the extended duration of action, this liposomal bupivacaine may be better at providing post-operative pain relief in laparoscopic surgery.
Phase three trials have shown better pain control in the first 24 hours and less opioid use overall in bunionectomies, hemorrhoidectomies, and total knee replacement surgery when compared to placebo. No studies, however, have been published evaluating extended-release liposomal bupivacaine for laparoscopic surgery, or gynecologic surgery in general. Currently, we are using liposomal bupivacaine for pain relief after laparoscopic hysterectomies, but as stated, it has never been formally evaluated.
We hypothesize that liposomal bupivacaine ("extended-release") provides extended pain relief and decreases the need for supplemental opioid use after major laparoscopic surgery. We will be evaluating whether pre-incision infiltration of extended-release bupivacaine decreases post-operative pain from laparoscopic and robotic-assisted hysterectomy compared to bupivacaine HCl ("short-acting"). To achieve this evaluation we designed a double-blinded randomized controlled trial.
Patients who are scheduled to undergo a laparoscopic or robotic-assisted hysterectomy will be invited to participate. Group A will receive pre-incision infiltration of each trocar site with 4 ml of 0.25% Bupivacaine HCl. Group B will receive pre-incision infiltration of each trocar site with 4 ml of extended-release bupivacaine (EXPAREL) (13.3mg/ml). Subjects and outcome assessors will be blinded to group allocation.
Data will be collected while patients are in the hospital on pain levels and consumption of opioid pain medications. Upon discharge, pain levels, functioning, and quantity of opioid and non-steroidal anti-inflammatory (NSAID) pain medications will be collected through online questionnaires. Subjects will be followed until their 2-3 weeks post-operative visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine | Experimental | extended-release bupivacaine (EXPAREL) |
|
| Bupivacaine HCl | Active Comparator | short-acting bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivacaine | Drug | pre-incision infiltration with liposomal bupivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) Post-operative Pain Score on Post-Operative Day 1 (POD1). | Numerical Rating Scale (0-10) post-operative pain score on POD1, where 0 = no pain and 10 = worst pain imaginable | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| NRS Pain Score at 2 Hours | numeric rating scale (0-10), mean and SD, where 0 = no pain and 10 = worst pain imaginable | 2 hours post-op |
| NRS Pain Score at 4 Hours | Pain scale measured from 0-10, where 0 = no pain and 10 = worst pain imaginable |
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Inclusion Criteria:
Exclusion Criteria:
Planned additional procedures (e.g. incontinence surgery, prolapse repair or bowel surgery)
Contraindication to study drug
History of substance or alcohol abuse within the past 2 years
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| Name | Affiliation | Role |
|---|---|---|
| Georgine Lamvu, MD, MPH | Florida Hospital Orlando | Principal Investigator |
| Kenneth I Barron, MD | Florida Hospital Orlando | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital Orlando | Orlando | Florida | 32804 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11342725 | Background | Saleh A, Fox G, Felemban A, Guerra C, Tulandi T. Effects of local bupivacaine instillation on pain after laparoscopy. J Am Assoc Gynecol Laparosc. 2001 May;8(2):203-6. doi: 10.1016/s1074-3804(05)60578-6. | |
| 9840560 | Background | Ke RW, Portera SG, Bagous W, Lincoln SR. A randomized, double-blinded trial of preemptive analgesia in laparoscopy. Obstet Gynecol. 1998 Dec;92(6):972-5. doi: 10.1016/s0029-7844(98)00303-2. |
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There is not a plan to make IPD available, but aggregate data can be made available to interested correspondents
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine | extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine |
| FG001 | Bupivacaine HCl | short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine | extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine |
| BG001 | Bupivacaine HCl | short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl |
| 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 | Numerical Rating Scale (NRS) Post-operative Pain Score on Post-Operative Day 1 (POD1). | Numerical Rating Scale (0-10) post-operative pain score on POD1, where 0 = no pain and 10 = worst pain imaginable | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
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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 | Liposomal Bupivacaine | extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine |
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study published in JMIG. https://doi.org/10.1016/j.jmig.2016.11.002
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth I Barron | Center for Advanced Gynecology, PLLC | 5088876896 | kenneth.barron.md@gmail.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine HCl | Drug | pre-incision infiltration with bupivacaine HCl |
|
|
| 4 hours post-op |
| NRS Pain Score at 8 Hours | Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable | 8 hours post-op |
| NRS Pain Score at 16 Hours | Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable | 16 hours post-op |
| NRS Pain Score Post-op Day 2 | Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable | 2 days post-op |
| NRS Pain Score Post-op Day 3 | Pain scale, where 0 = no pain and 10 = worst pain imaginable | 3 days post-op |
| NRS Pain Score Post-op Day 14 | Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable | Post-Operative Day 14 |
| Quality of Life as Measured by the Brief Pain Inventory (BPI) | The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes | Post-Operative Day 2 |
| Quality of Life as Measured by the Brief Pain Inventory (BPI) | The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes | Post-Operative Day 3 |
| Quality of Life as Measured by the Brief Pain Inventory (BPI) | at time of post-op visit The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes | Post-Operative Day 14 |
| Total Opioid Use Prior to Hospital Discharge | Oral morphine equivalent of opioid use while in the hospital | 24 hours |
| Total Opioid Use End of Post-op Day 3 | Total use of home opioids by pill count/ oral morphine equivalents | 72 hrs post-op |
| Total Opioid Use at Post-op Day 14 | Total use of home opioids by pill count/ oral morphine equivalents | Post-Operative Day 14 |
| Number of Participants With Adverse Events | Post-Operative Day 14 |
| 24619479 | Background | Loizides S, Gurusamy KS, Nagendran M, Rossi M, Guerrini GP, Davidson BR. Wound infiltration with local anaesthetic agents for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 12;2014(3):CD007049. doi: 10.1002/14651858.CD007049.pub2. |
| 24645765 | Background | Bergese SD, Onel E, Portillo J. Evaluation of DepoFoam((R)) bupivacaine for the treatment of postsurgical pain. Pain Manag. 2011 Nov;1(6):539-47. doi: 10.2217/pmt.11.62. |
| 21842428 | Background | Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam(R) bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. 2011 Sep;28(9):776-88. doi: 10.1007/s12325-011-0052-y. Epub 2011 Aug 12. |
| 22067185 | Background | Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1. |
| 22285545 | Background | Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28. |
| 10741813 | Background | Kato J, Ogawa S, Katz J, Nagai H, Kashiwazaki M, Saeki H, Suzuki H. Effects of presurgical local infiltration of bupivacaine in the surgical field on postsurgical wound pain in laparoscopic gynecologic examinations: a possible preemptive analgesic effect. Clin J Pain. 2000 Mar;16(1):12-7. doi: 10.1097/00002508-200003000-00003. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Full Range | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | NRS Pain Score at 2 Hours | numeric rating scale (0-10), mean and SD, where 0 = no pain and 10 = worst pain imaginable | Posted | Mean | Standard Deviation | units on a scale | 2 hours post-op |
|
|
|
| Secondary | NRS Pain Score at 4 Hours | Pain scale measured from 0-10, where 0 = no pain and 10 = worst pain imaginable | Posted | Mean | Standard Deviation | Score on a scale | 4 hours post-op |
|
|
|
| Secondary | NRS Pain Score at 8 Hours | Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable | Posted | Mean | Standard Deviation | Score on a scale | 8 hours post-op |
|
|
|
| Secondary | NRS Pain Score at 16 Hours | Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable | Posted | Mean | Standard Deviation | score on a scale | 16 hours post-op |
|
|
|
| Secondary | NRS Pain Score Post-op Day 2 | Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable | Posted | Mean | Standard Deviation | score on a scale | 2 days post-op |
|
|
|
| Secondary | NRS Pain Score Post-op Day 3 | Pain scale, where 0 = no pain and 10 = worst pain imaginable | Posted | Mean | Standard Deviation | score on a scale | 3 days post-op |
|
|
|
| Secondary | NRS Pain Score Post-op Day 14 | Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable | Posted | Mean | Standard Deviation | score on a scale | Post-Operative Day 14 |
|
|
|
| Secondary | Quality of Life as Measured by the Brief Pain Inventory (BPI) | The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes | Posted | Mean | Standard Deviation | score on a scale | Post-Operative Day 2 |
|
|
|
| Secondary | Quality of Life as Measured by the Brief Pain Inventory (BPI) | The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes | Posted | Mean | Standard Deviation | score on a scale | Post-Operative Day 3 |
|
|
|
| Secondary | Quality of Life as Measured by the Brief Pain Inventory (BPI) | at time of post-op visit The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes | Posted | Mean | Standard Deviation | score on a scale | Post-Operative Day 14 |
|
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| Secondary | Total Opioid Use Prior to Hospital Discharge | Oral morphine equivalent of opioid use while in the hospital | Posted | Mean | Full Range | mg (oral morphine equivalents) | 24 hours |
|
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| Secondary | Total Opioid Use End of Post-op Day 3 | Total use of home opioids by pill count/ oral morphine equivalents | Posted | Mean | Full Range | mg (oral morphine equivalents) | 72 hrs post-op |
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| Secondary | Total Opioid Use at Post-op Day 14 | Total use of home opioids by pill count/ oral morphine equivalents | Posted | Mean | Full Range | mg (oral morphine equivalents) | Post-Operative Day 14 |
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| Secondary | Number of Participants With Adverse Events | if a patient reported a particular adverse effect at more than one time point, the patient was counted only once. Patients may report more than one adverse effect. Analysis and percentages reflect only those with complaints of adverse effects. | Posted | Count of Participants | Participants | Post-Operative Day 14 |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Bupivacaine HCl | short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl | 0 | 32 | 0 | 32 | 0 | 32 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| Nausea |
|
| Headache |
|
| Sore throat/cough |
|
| Dizziness |
|