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

NCT03266926 | Completed FDA Drug

• 1 other identifier: SBK Vaginal Pack Study
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Intraoperative Blood Loss

  One time measurement, intra-operative

• Postoperative Hemoglobin

  Morning of postoperative day one

• Analgesic Use In Hospital

  From when surgery ends to time of discharge from hospital post operative day 1

• Post-operative per vaginal blood loss

  From when surgery ends to time of discharge from hospital post operative day 1

• Trial of Void

  Up to six weeks postoperative

Study Arms (2)

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

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

Interventions

Bupivacaine DRUG

0.25% Bupivacaine with epinephrine will be applied to vaginal packing that is placed post vaginal reconstruction surgery.

Also known as: Marcaine

Postoperative Patients with bupivacaine

Premarin Vaginal cream DRUG

A Premarin vaginal cream will be used to coat the vaginal pack, prior to insertion in patients post vaginal reconstruction surgery.

Also known as: estrogen vaginal cream

Postoperative Patients with premarin

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants are eligible if they are undergoing vaginal reconstructive surgery.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing vaginal reconstructive surgery at Sunnybrook Health Sciences Centre.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related 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.

  PMID: 26718780 BACKGROUND

• 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.

  PMID: 24310987 BACKGROUND

• 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.

  PMID: 26825408 BACKGROUND

• 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.

  PMID: 22914480 BACKGROUND

• 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.

  PMID: 25281438 BACKGROUND

• 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.

  PMID: 26511988 BACKGROUND

• 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.

  PMID: 15949082 BACKGROUND

• 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.

  PMID: 21120661 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Patricia Lee, MD

  Sunnybrook Health Sciences Centre, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 30, 2017
• Study Start: February 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)