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

NCT ID: NCT02547155

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Spinal anesthesia

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

General anesthesia

Intervention Type: PROCEDURE

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

Interventions

Spinal anesthesia

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

Intervention Type: PROCEDURE

General anesthesia

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Laura Martin

Urogynecology Fellow in the Department of Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Martin, DO

Role: PRINCIPAL_INVESTIGATOR

Clevland Clinic Florida

Locations

Cleveland Clinic Florida

Weston, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laura Maritn, DO

Role: CONTACT

martinl4@ccf.org

954-659-5559

G Willy Davila, MD

Role: CONTACT

davilag@ccf.org

954-659-5559

Facility Contacts

Laura Martin, MD

Role: primary

martinl4@ccf.org

954-659-5559

References

Alas A, Martin L, Devakumar H, Frank L, Vaish S, Chandrasekaran N, Davila GW, Hurtado E. Anesthetics' role in postoperative urinary retention after pelvic organ prolapse surgery with concomitant midurethral slings: a randomized clinical trial. Int Urogynecol J. 2020 Jan;31(1):205-213. doi: 10.1007/s00192-019-03917-w. Epub 2019 Mar 23.

Reference Type: DERIVED

PMID: 30904934 (View on PubMed)

Other Identifiers

FLA 15-019

Identifier Type: -

Identifier Source: org_study_id