Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
NCT Number: NCT03266926
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.
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Notify Me18 year and older
Female
Observational
Toronto, Ontario, M4N 3M5, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.25% Bupivacaine with epinephrine will be applied to vaginal packing that is placed post vaginal reconstruction surgery.
Other names: Marcaine
A Premarin vaginal cream will be used to coat the vaginal pack, prior to insertion in patients post vaginal reconstruction surgery.
Other names: estrogen vaginal cream
Time frame: The outcome measure will be assessed six hours postoperative
Primary outcome is postoperative pain score 6 hours post surgery on POD#0
Time frame: One time measurement, intra-operative
Estimate by the surgeon regarding total blood loss
Time frame: Morning of postoperative day one
Measure of hemoglobin on the morning of postoperative day one
Time frame: 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
Time frame: From when surgery ends to time of discharge from hospital post operative day 1
As subjectively described by RN in chart
Time frame: Up to six weeks postoperative
Number of days required by the patient to pass a trial of void
Time frame: 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
Time frame: The outcome measure will be assessed two hours postoperative
postoperative pain score 2 hours post surgery on POD#0
Time frame: The outcome measure will be assessed on the morning of postoperative day one.
postoperative pain score on the morning of postoperative day one
Sunnybrook Health Sciences Centre
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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