Clinical trial NCT04171050
Conditions: Pain Management
Keywords: Pain Management Pudendal Nerve Block (PNB) Vaginal Reconstruction
Sponsor: University of California, Los Angeles
Start date: 2019-11-14; Completion date: 2023-08-28
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Detailed description:
PROTOCOL SUMMARY AND/OR SCHEMA

To determine whether administration of a PNB at time of vaginal reconstructive surgery can reduce use of narcotics and reported pain scores in the immediate postoperative period within the setting of multimodal postoperative pain control of ERAS. Women \>18yo undergoing vaginal reconstructive surgery without a hysterectomy will be randomized to either standard of care with typical use of local anesthetic during their surgery versus perioperative PNB in addition to typical use of local anesthetic during their surgery. PNB will be performed with 0.5% bupivacaine and 10cc will be injected bilaterally. All patients will be on a standard preoperative and postoperative multimodal pain regimen. Patients will be followed until 6 weeks after surgery.

OVERVIEW OF STUDY DESIGN/INTERVENTION

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 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).

All pain medication will be standardized. Preoperative medications per our ERAS protocol will include oral acetaminophen 1000mg, gabapentin 600mg, and celecoxib 400mg. During surgery the patient will undergo their randomized intervention as either Group 1 or Group 2. Postoperative medications per our ERAS protocol including scheduled acetaminophen 1,000mg PO every 6 hours and ketorolac 30mg IV every 6 hours. For supplemental pain medication patients will have the following available: tramadol 50mg PO every 6 hours as needed for moderate pain (pain 4-6/10 on NRS scale), tramadol 100mg PO every 6 hours as needed for severe pain (pain 7-10/10 on NRS scale), and oxycodone 5mg PO every 4 hours as needed for breakthrough pain as supplemental pain medication. If the above regimen does not allow for sufficient pain control then additional hydromorphone IV 0.2mg or morphine IV 2mg can be ordered by the provider as needed, but will not be standard in the postoperative order set. 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.

The patients' pain scores on the numeric rating scale (NRS) and supplemental opioid use measured in morphine milligram equivalent (MME) will be tracked during their hospitalization, which is typically a 23-hour observation. They will then be called at 48 hours for further follow-up on pain score by NRS and asked how much opioid medication they have taken since leaving the hospital and their overall satisfaction with their pain control. To help with the determination of supplemental pain medication used and pain scores, the patients will be provided a worksheet upon discharge that outlines their recommended medication routine, allows them to record their supplemental opioid medication use with dose and time, and also provides space for them to record their pain score at 48 hours post operatively. The patient will then be contacted at 2 weeks after surgery to determine if they have returned to normal activities (walking, sitting, and performing daily household tasks comfortably) and if so at what point this occurred, as well as their overall satisfaction with their postoperative pain control again. The two week contact will be either a phone call or clinic visit depending on the provider's preference for patient follow-up. The last point of contact will be at 6 weeks to determine time to return to normal activities, if they had not met this milestone at the 2-week contact, and again assess their overall satisfaction with their postoperative pain control. If a patient is discharge same day instead of admitted for 23-hour observation they will also receive a call at 24 hours postoperative to check on pain score and supplemental pain medication used.

Arms: arm 1: Standard of care with local anesthesia used during surgery arm 2: Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery
Interventions: intervention 1: Local anaesthetic intervention 2: Pudendal Nerve Block plus anesthesia
Intervention descriptions: intervention 1: Local anesthesia injections intervention 2: Local anesthesia injections plus a pudendal nerve block

Protocol documents:
Prot_SAP_000.pdf: 
Tamara Grisales, MD 
Confidential 
University of California, Los Angeles 
Research Protocol 
Pudenda I Enhancement of ERAS for Reconstructive Surgery (PEERS study) 
Protocol Number: 
1.2 
Version Date: 
5/30/20 
Development Phase: 
Final 
Sponsor: 
Tamara Grisales 
200 Medical Plaza Suite 140 
Los Angeles, CA 90095 
Funding Organization: 
UCLA Division of Female Pelvic Medicine and 
Reconstructive Surgery 
Principal Investigator: 
Name: Tamara Grisales 
Telephone: (310) 794-0206 
Fax: (310) 794-0211 
E-mail: tgrisales@mednet.ucla.edu
Approval: t}W 
PI or Sponsor Signature (Name and Title) 
Date 
This confidential information about an investigational product is provided for the 
exclusive use of investigators of this product and is subject to recall at any time. 
The information in this document may not be disclosed unless federal or state law 
or regulations require such disclosure. Subject to the foregoing, this information 
may be disclosed only to those persons involved in the study who have a need to 
know, with the obligation not to further disseminate this information. 
Version#: 1.2 
Version Date: 5/30/20 
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NCT04171050