CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 44 enrolled
Drug / intervention
Local anaesthetic +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04171050
NCT04171050Phase 4Completed

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

University of California, Los Angeles·interventional·Posted Nov 20, 2019·Updated Jun 3, 2025

In Brief

A Phase 4 clinical trial evaluating Local anaesthetic and Pudendal Nerve Block plus anesthesia for Pain Management. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain Management
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedNov 20, 2019
Enrollment StartNov 14, 2019
Primary CompletionAug 28, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.6 years ago

Interventions

Local anaestheticdrug

Local anesthesia injections

Pudendal Nerve Block plus anesthesiadrug

Local anesthesia injections plus a pudendal nerve block