Clinical trial NCT03266926: Does the Use of Bupivacaine Soaked Vaginal Packing Following Vaginal Surgery Decrease Postoperative Pain?
Official title: Does the Use of Bupivacaine Soaked Vaginal Packing Following Vaginal Surgery Decrease Postoperative Pain?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Postoperative Pain
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing vaginal reconstructive surgery at 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: The outcome measure will be assessed six hours postoperative
Secondary outcomes:
measure: Intraoperative Blood Loss
timeFrame: One time measurement, intra-operative
measure: Postoperative Hemoglobin
timeFrame: Morning of postoperative day one
measure: Analgesic Use In Hospital
timeFrame: From when surgery ends to time of discharge from hospital post operative day 1
measure: Post-operative per vaginal blood loss
timeFrame: From when surgery ends to time of discharge from hospital post operative day 1
measure: Trial of Void
timeFrame: Up to six weeks postoperative
measure: Analgesic Use Postoperative
timeFrame: Up to six weeks postoperative
measure: Visual Analog Scale (VAS)
timeFrame: The outcome measure will be assessed two hours postoperative
measure: Visual Analog Scale (VAS)
timeFrame: The outcome measure will be assessed on the morning of postoperative day one.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre, University of Toronto
name: Patricia Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Thiagamoorthy 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.
citation: Westermann 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.
citation: Mercier RJ, Zerden ML. Intrauterine anesthesia for gynecologic procedures: a systematic review. Obstet Gynecol. 2012 Sep;120(3):669-77. doi: 10.1097/AOG.0b013e3182639ab5.
citation: Simavli 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.
citation: Haytoglu 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.
citation: Buchanan 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.
citation: Karaman 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.