Phase 4
N=44
Pudendal Enhancement of Enhanced Recovery After Surgery (ERAS) for Reconstructive Surgery (PEERS)
Pain Management
Bottom Line
View on ClinicalTrials.gov: NCT04171050 ↗Enrolled (actual)
44
Serious AEs
2.3%
Results posted
Jun 2025
Primary outcome: Primary: Narcotic Use — 8; 6.75 MME
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Local anaesthetic (Drug); Pudendal Nerve Block plus anesthesia (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, Los Angeles
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Narcotic Use |
8; 7 | — |
| PRIMARY Narcotic Use |
8; 7 | — |
| SECONDARY Pain Scores |
1.2; 1.6; 1.4; 1.1; 1.9; 1.4 | — |
| SECONDARY Return to Normal Daily Activities |
10; 10 | — |
| SECONDARY Patient Satisfaction With Postoperative Recovery |
16; 13; 3; 4; 0; 1 | — |
| SECONDARY Length of Hospital Stay |
16.5; 9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04171050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.