Nitrous Oxide for Analgesia During Office Urethral Bulking
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Urology |
| Therapuetic Areas: | Musculoskeletal, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 3/2/2019 |
| Start Date: | February 15, 2019 |
| End Date: | December 1, 2020 |
| Contact: | Margaret R Hines, MD |
| Email: | margaret.hines@bswhealth.org |
| Phone: | 254-724-7573 |
Nitrous Oxide for Analgesia During Office Urethral Bulking: a Randomized, Controlled Trial
This study is designed to determine primarily if there is a difference in perceived pain in
patients receiving urethral bulking with calcium hydroxylapatite using local lidocaine versus
local lidocaine plus nitrous oxide gas. Patients will be randomized to a control group (local
lidocaine plus room air) or a intervention group (local lidocaine plus 50% nitrous oxide/50%
oxygen inhaled mixture). Their pain will be assessed immediately after the procedure, and
their recollection of pain will also be assessed at their 2 week post-procedure visit. There
are other secondary outcome measures as well; please see outcome measures section for full
description.
patients receiving urethral bulking with calcium hydroxylapatite using local lidocaine versus
local lidocaine plus nitrous oxide gas. Patients will be randomized to a control group (local
lidocaine plus room air) or a intervention group (local lidocaine plus 50% nitrous oxide/50%
oxygen inhaled mixture). Their pain will be assessed immediately after the procedure, and
their recollection of pain will also be assessed at their 2 week post-procedure visit. There
are other secondary outcome measures as well; please see outcome measures section for full
description.
Inclusion Criteria:
- Female patients
- greater than or equal to 18 years old
- with demonstrable stress incontinence on supine stress test
- undergoing calcium hydroxylapatite injection for urethral bulking for the first time
- able to consent to the study and procedure
Exclusion Criteria:
- < 18 years old
- prior urethral bulking therapy
- predominant urge incontinence symptoms
- contraindications to nitrous oxide
- pre-existing significant cardiopulmonary disease
- hypotension defined as systolic blood pressure (BP) < 90 or diastolic BP <50 on
initial BP in the office
- chronic pain disorders (specifically fibromyalgia, chronic pelvic pain, sciatica or
chronic low back pain, painful bladder syndrome)
- chronic narcotic use (defined as taking a narcotic medication >3 days per week during
the past two weeks)
- pregnancy
- conditions of air trapping (bullous emphysema, bowel obstruction, pneumothorax,
intracranial air, middle ear conditions, status post recent diving, recent eye
surgery)
- lidocaine allergy
- neurologic diseases impairing pain perception.
We found this trial at
1
site
2401 South 31st Street
Temple, Texas 76508
Temple, Texas 76508
Principal Investigator: Margaret R Hines, MD
Phone: 254-724-7573
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