Skip to main content
OpenTrials
Completed

NCT Number: NCT03266926

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

0.25% Bupivacaine with epinephrine will be applied to vaginal packing that is placed post vaginal reconstruction surgery.

Other names: Marcaine

Premarin Vaginal cream

Drug

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

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: The outcome measure will be assessed six hours postoperative

    Primary outcome is postoperative pain score 6 hours post surgery on POD#0

Secondary outcomes

  1. Intraoperative Blood Loss

    Time frame: One time measurement, intra-operative

    Estimate by the surgeon regarding total blood loss

  2. Postoperative Hemoglobin

    Time frame: Morning of postoperative day one

    Measure of hemoglobin on the morning of postoperative day one

  3. Analgesic Use In Hospital

    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

  4. Post-operative per vaginal blood loss

    Time frame: From when surgery ends to time of discharge from hospital post operative day 1

    As subjectively described by RN in chart

  5. Trial of Void

    Time frame: Up to six weeks postoperative

    Number of days required by the patient to pass a trial of void

  6. Analgesic Use Postoperative

    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

  7. Visual Analog Scale (VAS)

    Time frame: The outcome measure will be assessed two hours postoperative

    postoperative pain score 2 hours post surgery on POD#0

  8. Visual Analog Scale (VAS)

    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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 30, 2017
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.