Open Actively Recruiting

Pudendal Enhancement of Enhanced Recovery After Surgery (ERAS) for Reconstructive Surgery (PEERS)

About

Brief Summary

Patients will undergo their vaginal reconstructive surgery in the usual manner, but will also be randomly assigned on the day of surgery to either receive the extra injection of numbing medication at the onset of surgery or not. The chances they will be assigned to the additional injection is 50%. Their care in the hospital and after surgery will be the same. They will participate in the study for a total of 6 weeks during which time they will be asked to complete two phone surveys, during which a provider will check in on pain level and pain medication use, and one office visit at 6 weeks. The office visit is part of their routine care and would be a scheduled visit regardless if they participated in the study or not. If they are unable to return to the office for a postoperative visit at 6 weeks, they will be contact by phone instead to obtain information on satisfaction with postoperative care, any complications after surgery, and overall how they are doing after surgery.

Primary Purpose
Supportive Care
Study Type
Interventional
Phase
Phase 4

Eligibility

Gender
Female
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
99 Years

Inclusion Criteria:

  • Female
  • Age > 18 years old
  • English speaking
  • Undergoing vaginal reconstructive surgery of at least 2 compartments (anterior vaginal wall, posterior vaginal wall, and/or apical suspension including hysteropexy, uterosacral ligament suspension, or sacrospinous ligament fixation)

Exclusion Criteria:

  • Hysterectomy at time of surgery-is variable in duration which may affect response to PNB
  • Inability to tolerate opioids-allergy or medical contraindication
  • Inability to tolerate local anesthetic agents-allergy or medical contraindication
  • Inability to tolerate NSAIDS-allergy or medical contraindication
  • Inability to tolerate acetaminophen-allergy or medical contraindication
  • Coagulation disorder
  • Chronic pain syndrome using opioid medication on a regular basis prior to surgery

Join this Trial

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Study Stats
Protocol No.
19-001550
Category
Obstetrics & Gynecology
Contact
TAMARA GRISALES
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04171050
For detailed technical eligibility, visit ClinicalTrials.gov.