NCT02547155

Does Spinal Anesthesia for Prolapse Surgery With Lead to Urinary Retention?

Does Spinal Anesthesia for Prolapse Surgery With Concomitant Sling Procedures Lead to an Increase in Urinary Retention Compared to General Anesthesia?

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to compare the risk of being unable to urinate shortly after surgery, also called acute post-operative urinary retention (POUR) between spinal and general anesthesia in women who undergo outpatient pelvic organ prolapse with stress urinary incontinence surgery.

Detailed description

A randomized trial to compare urinary retention rates between spinal and general anesthesia in women who undergo outpatient pelvic organ prolapse surgery with concomitant incontinence surgery. Randomization Randomization will be done in the pre-operative area, on the day of surgery. Computer generated randomization will be done in blocks of 4. Sealed numbered envelopes will be opened prior to surgery and the subject will then be assigned to spinal or general anesthesia. Patient randomization on day of surgery was discussed with anesthesia and it thought that randomizing on the same day would be safe. Preoperatively Subjects will be asked to complete a validated questionnaire, the Quality of Recovery 15 (QoR-15) prior to surgery, at their preoperative visit. Anesthesia Subjects randomized to general anesthesia will receive propofol induction, in combination with a muscle relaxant and inhalational gas per anesthesia standard of care at the investigators' institution. Subjects randomized to spinal anesthesia will receive Bupivacaine 0.75%, 8-12 mg dose depending on estimated duration of surgery and anesthesiologist decision. In addition to spinal anesthesia, these subjects will possibly have concurrent administration of fentanyl, midazolam, and propofol so that they are mildy sedated or sleeping. Voiding Trial A voiding trial will be performed in the PACU once the subjects are able to stand and ambulate to the bathroom. Voiding trial will consist of removing the vaginal packing and back filling the bladder with 300cc of saline or less if subject has urgency or a smaller bladder capacity. A voiding trial is considered successful if the subject voids at least 2/3 of the total volume instilled and has a bladder scan showing less than 1/3 remaining. If a subject is unable to void after an hour, an additional hour will be permitted. However, after 2 hours from when the bladder was backfilled the subject is still unable to void, the Foley will be replaced and the subjects will be discharged home with a Foley leg bag and leg bag teaching. An office nurse will call the subject and schedule an office nurse visit to remove the Foley between post-operative day number 5 to 7. If the subject goes home with a Foley this will be considered acute POUR. Follow Up Subjects will receive a phone call from either a nurse or fellow, between 48 to 72 hours post-operatively to make sure they are having no symptoms of urinary retention, are doing well and are not having any complications. A telephone survey will be administered during this follow up phone call using a validated questionnaire, the QoR-15. They will have received a copy of this survey to refer to at the time of their hospital discharge. Subjects who were admitted to the hospital will have the same follow up, including a phone call 48 to 72 hours after their surgery, including the validated questionnaire, the QoR-15. In addition, subjects will have a 6 week follow up visit in the clinic and will be asked to complete the QoR-15.

Conditions

• Urinary Retention
• Uterine Prolapse

Interventions

Type	Name	Description
PROCEDURE	Spinal anesthesia	8-12.5 mg of bupivacaine will be administered for spinal anesthesia
PROCEDURE	General anesthesia	propofol induction, in combination with a muscle relaxant and inhalational gas

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-09-11
• Last updated: 2017-04-20

Locations

1 site across 1 country: United States