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

August 6, 2019 updated by: Sunnybrook Health Sciences Centre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing vaginal reconstructive surgery at Sunnybrook Health Sciences Centre.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Postoperative Patients with premarin
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
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
Postoperative Patients with bupivacaine
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.
Other Names:
  • Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The outcome measure will be assessed six hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Blood Loss
Time Frame: One time measurement, intra-operative
Estimate by the surgeon regarding total blood loss
One time measurement, intra-operative
Postoperative Hemoglobin
Time Frame: Morning of postoperative day one
Measure of hemoglobin on the morning of postoperative day one
Morning of postoperative day one
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
From when surgery ends to time of discharge from hospital post operative day 1
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
From when surgery ends to time of discharge from hospital post operative day 1
Trial of Void
Time Frame: Up to six weeks postoperative
Number of days required by the patient to pass a trial of void
Up to six weeks postoperative
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
Up to six weeks postoperative
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
The outcome measure will be assessed two hours postoperative
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
The outcome measure will be assessed on the morning of postoperative day one.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Patricia Lee, MD, Sunnybrook Health Sciences Centre, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 26, 2017

First Posted (Actual)

August 30, 2017

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBK Vaginal Pack Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Study Protocol
  2. Informed Consent Form
  3. Individual Participant Data Set
  4. Participant Documents

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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