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

Completed

• Conditions: Pelvic Organ Prolapse; Postoperative Pain
• Interventions: Drug: Premarin Vaginal cream; Drug: Bupivacaine

• Registration Number: NCT03266926
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-26
• Study First Posted: 2017-08-30
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postoperative Patients with premarin	Premarin Vaginal cream	Patients who undergo vaginal surgery at Sunnybrook Health Sciences Centre (SHSC) who require vaginal packing postoperatively and receive premarin vaginal cream coated packing.
Postoperative Patients with bupivacaine	Bupivacaine	Patients who undergo vaginal surgery at Patients who undergo vaginal surgery (SHSC) who require vaginal packing postoperatively and receive bupivacaine soaked packing.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Postoperative Hemoglobin	Morning of postoperative day one	Measure of hemoglobin on the morning of postoperative day one
Intraoperative Blood Loss	One time measurement, intra-operative	Estimate by the surgeon regarding total blood loss
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
Trial of Void	Up to six weeks postoperative	Number of days required by the patient to pass a trial of void
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 on the morning of postoperative day one.	postoperative pain score on the morning of postoperative day one

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada