Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy

Study Overview
=================
Brief Summary
-----------------
Effective post-surgical pain management is a crucial component of a patient's postoperative course following posterior colporrhaphy. Narcotics are the cornerstone for postoperative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks. The colorectal, orthopedic and general surgery literatures have reported on an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute post-operative pain; however, literature regarding this medication specific to Urogynecology and Gynecology is limited. The investigators propose a prospective, randomized, double blind, trial with 120 subjects recruited from the Walter Reed National Military Medical Center (WRNMMC) Urogynecology Clinic to study postsurgical pain control after posterior repair. There will be two arms in the study; one arm with bupivacaine alone and a second arm with bupivacaine mixed with Exparel®(extended-release, liposomal bupivacaine) injected vaginally in patients undergoing posterior colporrhaphy. Subjects will be randomized to receive either 20 milliliter (mL) of plain bupivacaine or 20mL (10ml+10ml) mixture of bupivacaine plus Exparel®. The primary objective of the trial will be to evaluate the postsurgical vaginal pain using a visual analog pain scale at days 1, 2, 3 post-procedure. All subjects will have acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available for pain control regardless of assignment, which is the usual postoperative pain control regimen. The investigators hypothesize a 30% difference in post-operative pain measurements between the two groups. Additional objectives of this study are to evaluate total medication usage on days 1, 2 and 3 and any post-operative voiding and defecatory dysfunction, comparing the two groups

Official Title
-----------------
Efficacy of Injectable Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy: A Prospective, Randomized, Double-Blinded Trial

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Exparel plus plain bupivacaine
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females >18 years of age undergoing Urogynecologic surgery involving the posterior vaginal wall mucosa or muscularis including posterior colporrhaphy at Walter Reed National Military Medical Center. Patients must be able to read and understand written English or have an appropriate certified medical translator available. Exclusion Criteria: Known allergy to amide local anesthetics. Unstable cardiac arrhythmia. Hepatic impairment (including but not limited to patients under the care of their physician for severe hepatic disease, cirrhosis or hepatic cancer). Known pregnancy at time of surgery (pregnancy test morning of surgery if applicable). Regular use of narcotic pain medication, defined as use on most days of week at any time in the three months prior to surgery. Significant history of opioid or alcohol abuse or addiction (requiring treatment). Concurrent pain management requiring the use of epidural anesthesia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plain Bupivacaine<br>20 mL of 0.25% plain bupivacaine | Drug: Bupivacaine<br>* 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy<br>* Other names: marcaine;|
| Active Comparator: Exparel plus plain bupivacaine<br>10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed | Drug: Exparel plus plain bupivacaine<br>* 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy<br>* Other names: extended release liposomal bupivacaine plus marcaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively | Patients will be asked on postoperative day (POD) 1 to provide numerical values regarding vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale) | Subjects will be asked to provide numerical values on postoperative day 1. | 
| Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively | Patients will be asked on postoperative day (POD) 2 to provide numerical values for vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale) | Subjects will be asked to provide numerical values on postoperative day 2. | 
| Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively | Patients will be asked on postoperative day (POD) 3 to provide numerical values for vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale) | Subjects will be asked to provide numerical values on postoperative day 3. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount Ibuprofen Pain Medication Required During the Postoperative Period at Home | Calculate total postoperative ibuprofen used while at home via perform pill counts on postoperative days 1, 2, 3 (done via a phone call). This will allow calculation of total amount of ibuprofen utilized at home through postoperative day #3 | Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home) | 
| Amount Acetaminophen Pain Medication Required During the Postoperative Period at Home | Calculate total postoperative acetaminophen used while at home via perform pill counts on postoperative days 1, 2, 3 (done via a phone call). This will allow calculation of total amount of acetaminophen utilized at home through postoperative day #3 | Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home) | 
| Amount Opioid Pain Medication Required During the Postoperative Period (Through Day 3) | Calculate total postoperative opioid medications used while inpatient and perform pill counts on postoperative days 1, 2, 3 (done via a phone call or inpatient). This will allow calculation of total amount of opioid pain medications utilized through postoperative day #3 | Calculated throughout hospitalization and/or with phone call on postoperative day 1, 2, and 3 (total opioids utilized) | 
| Percentage of Participants Who Passed Active Voiding Trial Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group. | Investigators will record in patients passed active voiding trail prior to discharge home. | Postoperative active voiding trial on postoperative day 1. | 
| Rate of Post-operative Defecatory Function After Posterior Colporrhaphy, Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group. | Investigators will record in patients have had a bowel movement within the first three days postoperatively. | Postoperatively up to day 3 | 
| Impact of Vaginal Pain Scores on Quality of Life Measures (ACTIVITY) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group | Investigators will ask patients how is your vaginal pain impacting your ACTIVITY (quality of life question) and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3 | Subjects will be asked to provide numerical value on postoperative day 3. | 
| Impact of Vaginal Pain Scores on Quality of Life Measure (SLEEP) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group | Investigators will ask patients how is your vaginal pain impacting your SLEEP (quality of life question) and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3 | Subjects will be asked to provide numerical value on postoperative day 3. | 
| Impact of Vaginal Pain Scores on Quality of Life Measure (MOOD) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group | Investigators will ask patients how is your vaginal pain impacting your MOOD (quality of life question) and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3 | Subjects will be asked to provide numerical value on postoperative day 3. | 
| Impact of Vaginal Pain Scores on Quality of Life Measure (STRESS) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group | Investigators will ask patients how is your vaginal pain impacting your STRESS (quality of life question) and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3 | Subjects will be asked to provide numerical value on postoperative day 3. |