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

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ClinicalTrials.gov Identifier: NCT04171050
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Tamara Grisales, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Pain Management Drug: Local anaesthetic Drug: Pudendal Nerve Block plus anesthesia Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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).

Masking: Double (Participant, Care Provider)
Masking Description: 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
Primary Purpose: Supportive Care
Official Title: Pudendal Enhancement of Enhanced Recovery After Surgery (ERAS) for Reconstructive Surgery (PEERS)
Actual Study Start Date : November 14, 2019
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1: Local Anesthesia
Standard of care with local anesthesia used during surgery
Drug: Local anaesthetic
Local anesthesia injections

Active Comparator: Group 2: Local Anesthesia plus Pudendal Nerve Block
Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery
Drug: Pudendal Nerve Block plus anesthesia
Local anesthesia injections plus a pudendal nerve block




Primary Outcome Measures :
  1. Narcotic use [ Time Frame: 24 hours after surgery ]
    Measured in MME at 24 hours

  2. Narcotic use [ Time Frame: 48 hours after surgery ]
    Measured in MME at 48 hours


Secondary Outcome Measures :
  1. Pain scores [ Time Frame: 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, and 48 hours after surgery ]
    Average pain score by Numerical Rating Scale (NRS). The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

  2. Return to normal daily activities [ Time Frame: 2 weeks after surgery and 6 weeks after surgery ]
    Days to return

  3. Patient satisfaction with postoperative recovery [ Time Frame: 48 hours after surgery, 2 weeks after surgery, and 6 weeks after surgery ]
    Questionnaire

  4. Length of hospital stay [ Time Frame: Tracked by hour through time of patient discharge (0 - 72 hours) ]
    Tracked in hours



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women over the age of 18 undergoing vaginal reconstructive surgery without a hysterectomy
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171050


Contacts
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Contact: Tamara Grisales, MD 310-983-1023 Tgrisales@mednet.ucla.edu
Contact: Jenny Lester, MPH 310-794-9728 jlester@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Jenny Lester    310-794-9728    jlester@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
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Responsible Party: Tamara Grisales, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04171050    
Other Study ID Numbers: Pudendal Enhancement of ERAS
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tamara Grisales, University of California, Los Angeles:
Pain Management
Pudendal Nerve Block (PNB)
Vaginal Reconstruction
Additional relevant MeSH terms:
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Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents