Recruiting

Spinal Anesthesia

Sponsor:

The Cleveland Clinic

Code:

NCT02547155

Conditions

Urinary Retention

Uterine Prolapse

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Accepted

Interventions

Spinal anesthesia

General anesthesia

Study Details

Brief 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.

Conditions

Urinary Retention

Uterine Prolapse

Study ID

NCT02547155

Start date

Mar, 2015

Status verified date

Apr, 2017

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Women over the age of 40
2. Women scheduled for pelvic organ prolapse surgery as well as concomitant incontinence sling surgery
3. Post-void residual <150 cc prior to surgery
4. Surgery length of at least 1 hour
5. BMI <40
6. ASA class 1-2

Exclusion Criteria:

1. Contraindications to surgery
2. Contraindications to outpatient surgery, and requiring inpatient stay for medical comorbidities. The decision for a required inpatient stay will be decided prior to surgery based on the recommendations of the patient's primary care physician or specialist, such as cardiology or pulmonology.
3. BMI >40
4. ASA class 3 or 4 that would be a contraindiction to both spinal or general anesthesia
5. Evidence of voiding dysfunction or urinary retention on pre-operative urodynamics, including PVR >150, or dyssynergic sphincter dyssynergia
6. Neurological diseases that can interfere with spinal anesthesia
7. Anticoagulation therapy within a week of surgery
8. History of back surgery that would prevent successful spinal anesthesia
9. History of back deformity, such as scoliosis that would prevent successful spinal anesthesia

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Spinal anesthesia

Subjects randomized to spinal anesthesia will receive Bupivacaine 0.75%, 8-12.5 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.

active comparator: General 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 our institution

Interventions

Spinal anesthesia

8-12.5 mg of bupivacaine will be administered for spinal anesthesia

General anesthesia

propofol induction, in combination with a muscle relaxant and inhalational gas

Primary outcome measure

  • Incidence of postoperative urinary retention [ Time Frame: within the first week after surgery ]

Central Contacts and Locations

Central contacts

Locations

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Contacts

More Information

Sponsor

The Cleveland Clinic

Last update posted

Apr 20, 2017

Last verified

Apr, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2017-04-20.