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

NCT04171050 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pudendal Enhancement of ERAS
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management

Keywords

Pain Management; Pudendal Nerve Block (PNB); Vaginal Reconstruction

Outcome Measures

Primary Outcomes (2)

• Narcotic Use

  Measured in morphine milligram equivalents (MME) at 24 hours

  24 hours after surgery

• Narcotic Use

  Measured in MME at 48 hours

  48 hours after surgery

Secondary Outcomes (4)

• Pain Scores

  0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours, 24 hours, and 48 hours after surgery

• Return to Normal Daily Activities

  6 weeks after surgery

• Patient Satisfaction With Postoperative Recovery

  48 hours after surgery, 2 weeks after surgery

• Length of Hospital Stay

  Tracked by hour through time of patient discharge (up to 72 hours)

Study Arms (2)

Group 1: Local Anesthesia

ACTIVE COMPARATOR

Standard of care with local anesthesia used during surgery

Drug: Local anaesthetic

Group 2: Local Anesthesia plus Pudendal Nerve Block

ACTIVE COMPARATOR

Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery

Drug: Pudendal Nerve Block plus anesthesia

Interventions

Local anaesthetic DRUG

Local anesthesia injections

Group 1: Local Anesthesia

Pudendal Nerve Block plus anesthesia DRUG

Local anesthesia injections plus a pudendal nerve block

Group 2: Local Anesthesia plus Pudendal Nerve Block

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Women over the age of 18 undergoing vaginal reconstructive surgery without a hysterectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Torosis M, Fullerton M, Kaefer D, Nitti V, Ackerman AL, Grisales T. Pudendal Block at the Time of Transvaginal Prolapse Repair: A Randomized Controlled Trial. Urogynecology (Phila). 2024 Aug 1;30(8):706-713. doi: 10.1097/SPV.0000000000001448. Epub 2024 Apr 19.

  PMID: 38640500 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, Local; Anesthesia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia and Analgesia

Results Point of Contact

• Title: Tamara Grisales, MD
• Organization: University of California, Los Angeles

tgrisales@mednet.ucla.edu

310-983-1023

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The providers will know what intervention the patients underwent, but the patients and the care team obtaining pain scores in the hospital will be blinded to the intervention
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This will be a prospective blinded randomized controlled trial. We will recruit women who are undergoing vaginal prolapse repair surgery with a Female Pelvic Medicine and Reconstructive Surgery fellowship-trained provider within the University of California, Los Angeles (UCLA) Health System. Women will be recruited prior to undergoing vaginal reconstructive surgery. They will then be randomized to control group with standard of care with local anesthesia used during surgery (Group 1) or PNB in addition to use of local anesthesia typically used during surgery (Group 2).

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 20, 2019
• Study Start: November 14, 2019
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: June 3, 2025
• Results First Posted: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)