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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03266926
• Other study ID #: SBK Vaginal Pack Study
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: August 2019
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 . 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Pelvic Organ Prolapse
• Postoperative Pain
• Prolapse

Intervention

Drug:
• Bupivacaine
0.25% Bupivacaine with epinephrine will be applied to vaginal packing that is placed post vaginal reconstruction surgery.
• Premarin Vaginal cream
A Premarin vaginal cream will be used to coat the vaginal pack, prior to insertion in patients post vaginal reconstruction surgery.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	Primary outcome is postoperative pain score 6 hours post surgery on POD#0	The outcome measure will be assessed six hours postoperative
Secondary	Intraoperative Blood Loss	Estimate by the surgeon regarding total blood loss	One time measurement, intra-operative
Secondary	Postoperative Hemoglobin	Measure of hemoglobin on the morning of postoperative day one	Morning of postoperative day one
Secondary	Analgesic Use In Hospital	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
Secondary	Post-operative per vaginal blood loss	As subjectively described by RN in chart	From when surgery ends to time of discharge from hospital post operative day 1
Secondary	Trial of Void	Number of days required by the patient to pass a trial of void	Up to six weeks postoperative
Secondary	Analgesic Use 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
Secondary	Visual Analog Scale (VAS)	postoperative pain score 2 hours post surgery on POD#0	The outcome measure will be assessed two hours postoperative
Secondary	Visual Analog Scale (VAS)	postoperative pain score on the morning of postoperative day one	The outcome measure will be assessed on the morning of postoperative day one.