Pelvic Organ ProlapseNCT03266926
Does the Use of Bupivacaine Soaked Vaginal Packing Following Vaginal Surgery Decrease Postoperative Pain?
An observational study of Pelvic Organ Prolapse and Postoperative Pain, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse, Postoperative Pain
- What is being tested?
- Bupivacaine and Premarin Vaginal cream
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2017to 1 Mar 2018
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women undergoing vaginal reconstructive surgery at Sunnybrook Health Sciences Centre.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse, Postoperative Pain
- Being tested
- Bupivacaine, Premarin Vaginal cream
- Medical subject headings
- Pelvic Organ Prolapse, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
0.25% Bupivacaine with epinephrine will be applied to vaginal packing that is placed post vaginal reconstruction surgery.
Premarin Vaginal creamDrug
Also called estrogen vaginal cream
A Premarin vaginal cream will be used to coat the vaginal pack, prior to insertion in patients post vaginal reconstruction surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Premarin 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. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Primary outcome is postoperative pain score 6 hours post surgery on POD#0
Measured: The outcome measure will be assessed six hours postoperative
Secondary outcomes (8)
Intraoperative Blood Loss
Estimate by the surgeon regarding total blood loss
Measured: One time measurement, intra-operative
Postoperative Hemoglobin
Measure of hemoglobin on the morning of postoperative day one
Measured: Morning of postoperative day one
Analgesic Use In Hospital
Compilation of total dose of Tylenol, anti-inflammatory, and narcotic use postoperatively
Measured: 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
Measured: 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
Measured: 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
Measured: Up to six weeks postoperative
Visual Analog Scale (VAS)
postoperative pain score 2 hours post surgery on POD#0
Measured: The outcome measure will be assessed two hours postoperative
Visual Analog Scale (VAS)
postoperative pain score on the morning of postoperative day one
Measured: The outcome measure will be assessed on the morning of postoperative day one.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Feb 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Lee, MD, Principal investigator, Sunnybrook Health Sciences Centre, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266926
- Sponsor's protocol ID
- SBK Vaginal Pack Study
- Status last verified
- Aug 2019
- First submitted
- 24 Aug 2017
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdullah B, Khong SY, Tan PC. Oestrogen-soaked vaginal packing for decubitus ulcer in advanced pelvic organ prolapse: a case series. Int Urogynecol J. 2016 Jul;27(7):1057-62. doi: 10.1007/s00192-015-2930-3. Epub 2015 Dec 30.
PubMed 26718780Thiagamoorthy G, Khalil A, Cardozo L, Srikrishna S, Leslie G, Robinson D. The value of vaginal packing in pelvic floor surgery: a randomised double-blind study. Int Urogynecol J. 2014 May;25(5):585-91. doi: 10.1007/s00192-013-2264-y. Epub 2013 Dec 6.
PubMed 24310987Westermann LB, Crisp CC, Oakley SH, Mazloomdoost D, Kleeman SD, Benbouajili JM, Ghodsi V, Pauls RN. To Pack or Not to Pack? A Randomized Trial of Vaginal Packing After Vaginal Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2016 Mar-Apr;22(2):111-7. doi: 10.1097/SPV.0000000000000238.
PubMed 26825408Mercier RJ, Zerden ML. Intrauterine anesthesia for gynecologic procedures: a systematic review. Obstet Gynecol. 2012 Sep;120(3):669-77. doi: 10.1097/AOG.0b013e3182639ab5.
PubMed 22914480Simavli S, Kaygusuz I, Kinay T, Akinci Baylan A, Kafali H. Bupivacaine-soaked absorbable gelatin sponges in caesarean section wounds: effect on postoperative pain, analgesic requirement and haemodynamic profile. Int J Obstet Anesth. 2014 Nov;23(4):302-8. doi: 10.1016/j.ijoa.2014.07.004. Epub 2014 Jul 18.
PubMed 25281438Haytoglu S, Kuran G, Muluk NB, Arikan OK. Different anesthetic agents-soaked sinus packings on pain management after functional endoscopic sinus surgery: which is the most effective? Eur Arch Otorhinolaryngol. 2016 Jul;273(7):1769-77. doi: 10.1007/s00405-015-3807-2. Epub 2015 Oct 28.
PubMed 26511988Buchanan MA, Dunn GR, Macdougall GM. A prospective double-blind randomized controlled trial of the effect of topical bupivacaine on post-operative pain in bilateral nasal surgery with bilateral nasal packs inserted. J Laryngol Otol. 2005 Apr;119(4):284-8. doi: 10.1258/0022215054020322.
PubMed 15949082Karaman E, Gungor G, Alimoglu Y, Kilic E, Tarakci E, Bozkurt P, Enver O. The effect of lidocaine, bupivacaine and ropivacaine in nasal packs on pain and hemorrhage after septoplasty. Eur Arch Otorhinolaryngol. 2011 May;268(5):685-9. doi: 10.1007/s00405-010-1432-7. Epub 2010 Dec 1.
PubMed 21120661Edell H, Li X, Myrox P, Michael A, Jolliffe C, Abraham T, Kiss A, Cao X, Gagnon LH, Bodley J, Kung R, Lee P. Vaginal Packing After Pelvic Floor Reconstructive Surgery: Does the Soaking Agent Used for Packing (Bupivacaine, Estrogen or Saline) Impact Postoperative Pain Scores? J Minim Invasive Gynecol. 2024 Dec;31(12):1050-1056. doi: 10.1016/j.jmig.2024.09.004. Epub 2024 Sep 14.
PubMed 39278590
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of Bupivacaine Soaked Vaginal Packing Following Vaginal Surgery Decrease Postoperative Pain?
- ClinicalTrials.gov ID
- NCT03266926
- Acronym / sponsor ID
- SBK Vaginal Pack Study
- Conditions
- Pelvic Organ Prolapse, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative Patients with premarin | – | Drug: Premarin Vaginal creamPatients 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 | – | Drug: BupivacainePatients who undergo vaginal surgery at Patients who undergo vaginal surgery (SHSC) who require vaginal packing postoperatively and receive bupivacaine soaked packing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing vaginal reconstructive surgery at Sunnybrook Health Sciences Centre.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: Marcaine0.25% Bupivacaine with epinephrine will be applied to vaginal packing that is placed post vaginal reconstruction surgery. | Drug | Postoperative Patients with bupivacaine |
| Premarin Vaginal creamAlso: estrogen vaginal creamA Premarin vaginal cream will be used to coat the vaginal pack, prior to insertion in patients post vaginal reconstruction surgery. | Drug | Postoperative Patients with premarin |
Primary outcome
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
8 secondary outcomes
Intraoperative Blood Loss
Time frame: One time measurement, intra-operative
Postoperative Hemoglobin
Time frame: 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
Post-operative per vaginal blood loss
Time frame: From when surgery ends to time of discharge from hospital post operative day 1
Trial of Void
Time frame: Up to six weeks postoperative
Analgesic Use Postoperative
Time frame: Up to six weeks postoperative
Visual Analog Scale (VAS)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Background: PubMed 26718780Abdullah B, Khong SY, Tan PC. Oestrogen-soaked vaginal packing for decubitus ulcer in advanced pelvic organ prolapse: a case series. Int Urogynecol J. 2016 Jul;27(7):1057-62. doi: 10.1007/s00192-015-2930-3. Epub 2015 Dec 30.
- Background: PubMed 24310987Thiagamoorthy G, Khalil A, Cardozo L, Srikrishna S, Leslie G, Robinson D. The value of vaginal packing in pelvic floor surgery: a randomised double-blind study. Int Urogynecol J. 2014 May;25(5):585-91. doi: 10.1007/s00192-013-2264-y. Epub 2013 Dec 6.
- Background: PubMed 26825408Westermann LB, Crisp CC, Oakley SH, Mazloomdoost D, Kleeman SD, Benbouajili JM, Ghodsi V, Pauls RN. To Pack or Not to Pack? A Randomized Trial of Vaginal Packing After Vaginal Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2016 Mar-Apr;22(2):111-7. doi: 10.1097/SPV.0000000000000238.
- Background: PubMed 22914480Mercier RJ, Zerden ML. Intrauterine anesthesia for gynecologic procedures: a systematic review. Obstet Gynecol. 2012 Sep;120(3):669-77. doi: 10.1097/AOG.0b013e3182639ab5.
- Background: PubMed 25281438Simavli S, Kaygusuz I, Kinay T, Akinci Baylan A, Kafali H. Bupivacaine-soaked absorbable gelatin sponges in caesarean section wounds: effect on postoperative pain, analgesic requirement and haemodynamic profile. Int J Obstet Anesth. 2014 Nov;23(4):302-8. doi: 10.1016/j.ijoa.2014.07.004. Epub 2014 Jul 18.
- Background: PubMed 26511988Haytoglu S, Kuran G, Muluk NB, Arikan OK. Different anesthetic agents-soaked sinus packings on pain management after functional endoscopic sinus surgery: which is the most effective? Eur Arch Otorhinolaryngol. 2016 Jul;273(7):1769-77. doi: 10.1007/s00405-015-3807-2. Epub 2015 Oct 28.
- Background: PubMed 15949082Buchanan MA, Dunn GR, Macdougall GM. A prospective double-blind randomized controlled trial of the effect of topical bupivacaine on post-operative pain in bilateral nasal surgery with bilateral nasal packs inserted. J Laryngol Otol. 2005 Apr;119(4):284-8. doi: 10.1258/0022215054020322.
- Background: PubMed 21120661Karaman E, Gungor G, Alimoglu Y, Kilic E, Tarakci E, Bozkurt P, Enver O. The effect of lidocaine, bupivacaine and ropivacaine in nasal packs on pain and hemorrhage after septoplasty. Eur Arch Otorhinolaryngol. 2011 May;268(5):685-9. doi: 10.1007/s00405-010-1432-7. Epub 2010 Dec 1.
- Derived from this study: PubMed 39278590Edell H, Li X, Myrox P, Michael A, Jolliffe C, Abraham T, Kiss A, Cao X, Gagnon LH, Bodley J, Kung R, Lee P. Vaginal Packing After Pelvic Floor Reconstructive Surgery: Does the Soaking Agent Used for Packing (Bupivacaine, Estrogen or Saline) Impact Postoperative Pain Scores? J Minim Invasive Gynecol. 2024 Dec;31(12):1050-1056. doi: 10.1016/j.jmig.2024.09.004. Epub 2024 Sep 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Lee, MD principal investigator
Sunnybrook Health Sciences Centre, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Postoperative Pain, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: The outcome measure will be assessed six hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03266926, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.