An observational study in Pelvic Organ Prolapse and Postoperative Pain, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-08.
Sponsored by Sunnybrook Health Sciences Centre · Observational
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.
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.
Women undergoing vaginal reconstructive surgery at Sunnybrook Health Sciences Centre.
Exclusion Criteria:
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
Patients who undergo vaginal surgery at Patients who undergo vaginal surgery (SHSC) who require vaginal packing postoperatively and receive bupivacaine soaked packing.
Drug: Bupivacaine
0.25% Bupivacaine with epinephrine will be applied to vaginal packing that is placed post vaginal reconstruction surgery.
Also known as: Marcaine
A Premarin vaginal cream will be used to coat the vaginal pack, prior to insertion in patients post vaginal reconstruction surgery.
Also known as: estrogen vaginal cream
Visual Analog Scale (VAS)
Primary outcome is postoperative pain score 6 hours post surgery on POD#0
Time frame: The outcome measure will be assessed six hours postoperative
Intraoperative Blood Loss
Estimate by the surgeon regarding total blood loss
Time frame: One time measurement, intra-operative
Postoperative Hemoglobin
Measure of hemoglobin on the morning of postoperative day one
Time frame: Morning of postoperative day one
Analgesic Use In Hospital
Compilation of total dose of Tylenol, anti-inflammatory, and narcotic use postoperatively
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to six weeks postoperative
Visual Analog Scale (VAS)
postoperative pain score 2 hours post surgery on POD#0
Time frame: The outcome measure will be assessed two hours postoperative
Visual Analog Scale (VAS)
postoperative pain score on the morning of postoperative day one
Time frame: The outcome measure will be assessed on the morning of postoperative day one.
Plan to share: No
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre