Does the Use of Bupivacaine Soaked Vaginal Packing Following Vaginal Surgery Decrease Postoperative Pain?

Study Overview
=================
Brief Summary
-----------------
In current practice, packing in the vagina overnight after vaginal surgery is typically used to prevent post-surgical vaginal bleeding. The vaginal packing is usually coated with either estrogen cream or bupivacaine at the investigators' hospital . There are reports in the literature that show nasal packing soaked with local anesthetic after nasal sinus surgery reduces post-surgical pain. To date, no studies have evaluated local anesthetic soaked vaginal packing after vaginal surgery and if this is associated with a reduction in post-surgical pain scores. The investigators seek to investigate if vaginal packing soaked with a local anesthetic reduces post-operative pain while providing the necessary action of minimizing potential post-surgical bleeding.

Detailed Description
-----------------
This is a prospective cohort, single centre, single-blinded study looking at a population of women post vaginal surgery with vaginal packing that is either coated with estrogen cream or 0.25% Bupivacaine + epinephrine (local anesthetic). Patients who have booked vaginal surgery for prolapse repair will be invited to participate in this study. A document describing the study will be provided for reading and will include the consent for the study. At the end of surgery, a vaginal pack is placed to decrease potential bleeding post surgery. At this time, patients will receive either vaginal packing with estrogen, or, the vaginal packing with 0.25% bupivacaine + epinephrine, according to physician preference. Patients and the nurses caring for them post surgery will be blinded as to which group the patient has been assigned to. The nurses in the recovery room and post operative ward will ask patients post surgery the day of surgery, (POD#0, two and six hours post OR) and POD#1 to rate the patients' surgical pain with a standardized, validated VAS pain score. Secondary outcomes will be recorded: the amount of analgesics used in hospital after surgery, intra-operative blood loss, post operative hemoglobin, the number of days until the patient is able to void, the amount of analgesics used at home after surgery (patients will be asked to keep a record of the total number of oral analgesic pain tablets used and on which day post surgery they stopped using pain medications) and other post surgical complications. Data will be stored in a secure, password protected desktop on site. Each patient will be assigned a unique number which can be traced back to a master file which will include patient identifiers (name, MRN, DOB). Data will be analyzed with the appropriate statistical tests. There are no additional tests or visits for patients. Patient study assignment will be disclosed to them at the 6 week routine post surgical examination/assessment visit.

Official Title
-----------------
Does the Use of Bupivacaine Soaked Vaginal Packing Following Vaginal Surgery Decrease Postoperative Pain?

Conditions
-----------------
Pelvic Organ Prolapse, Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Premarin Vaginal cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of 4 attending physicians (urogynecologists) of Sunnybrook Health Sciences Centre planning to undergo a vaginal hysterectomy and/or vaginal reconstructive surgery for pelvic organ prolapse. Subjects aged 18 years and older and able to provide informed consent Exclusion Criteria: Any patient undergoing abdominal prolapse repair or no vaginal repairs Patients undergoing vaginal obliterative procedures Patients with a known allergy or adverse reaction to Bupivacaine or contraindication to Premarin

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postoperative Patients with premarin<br>Patients who undergo vaginal surgery at Sunnybrook Health Sciences Centre (SHSC) who require vaginal packing postoperatively and receive premarin vaginal cream coated packing. | Drug: Premarin Vaginal cream<br>* A Premarin vaginal cream will be used to coat the vaginal pack, prior to insertion in patients post vaginal reconstruction surgery.<br>* Other names: estrogen vaginal cream;|
| Postoperative Patients with bupivacaine<br>Patients who undergo vaginal surgery at Patients who undergo vaginal surgery (SHSC) who require vaginal packing postoperatively and receive bupivacaine soaked packing. | Drug: Bupivacaine<br>* 0.25% Bupivacaine with epinephrine will be applied to vaginal packing that is placed post vaginal reconstruction surgery.<br>* Other names: Marcaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | Primary outcome is postoperative pain score 6 hours post surgery on POD#0 | The outcome measure will be assessed six hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Blood Loss | Estimate by the surgeon regarding total blood loss | One time measurement, intra-operative | 
| Postoperative Hemoglobin | Measure of hemoglobin on the morning of postoperative day one | Morning of postoperative day one | 
| Analgesic Use In Hospital | Compilation of total dose of Tylenol, anti-inflammatory, and narcotic use postoperatively | From when surgery ends to time of discharge from hospital post operative day 1 | 
| Post-operative per vaginal blood loss | As subjectively described by RN in chart | From when surgery ends to time of discharge from hospital post operative day 1 | 
| Trial of Void | Number of days required by the patient to pass a trial of void | Up to six weeks postoperative | 
| Analgesic Use Postoperative | Compilation of total dose of Tylenol, anti-inflammatory, and narcotic use from date of discharge to six week follow up | Up to six weeks postoperative | 
| Visual Analog Scale (VAS) | postoperative pain score 2 hours post surgery on POD#0 | The outcome measure will be assessed two hours postoperative | 
| Visual Analog Scale (VAS) | postoperative pain score on the morning of postoperative day one | The outcome measure will be assessed on the morning of postoperative day one. |