Pelvic Organ Prolapse, Postoperative Pain
Conditions
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.
Interventions
DRUGBupivacaine
0.25% Bupivacaine with epinephrine will be applied to vaginal packing that is placed post vaginal reconstruction surgery.
A Premarin vaginal cream will be used to coat the vaginal pack, prior to insertion in patients post vaginal reconstruction surgery.
Sponsors
Sunnybrook Health Sciences Centre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | The outcome measure will be assessed six hours postoperative | Primary outcome is postoperative pain score 6 hours post surgery on POD#0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Hemoglobin | Morning of postoperative day one | Measure of hemoglobin on the morning of postoperative day one |
| Analgesic Use In Hospital | From when surgery ends to time of discharge from hospital post operative day 1 | Compilation of total dose of Tylenol, anti-inflammatory, and narcotic use postoperatively |
| Post-operative per vaginal blood loss | From when surgery ends to time of discharge from hospital post operative day 1 | As subjectively described by RN in chart |
| Intraoperative Blood Loss | One time measurement, intra-operative | Estimate by the surgeon regarding total blood loss |
| Analgesic Use Postoperative | Up to six weeks postoperative | Compilation of total dose of Tylenol, anti-inflammatory, and narcotic use from date of discharge to six week follow up |
| Visual Analog Scale (VAS) | The outcome measure will be assessed two hours postoperative | postoperative pain score 2 hours post surgery on POD#0 |
| Trial of Void | Up to six weeks postoperative | Number of days required by the patient to pass a trial of void |
Countries
Canada
Outcome results
None listed