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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-14

Study Completion Date

2023-08-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery

NCT04428320

Pelvic Floor Prolapse Surgery Pain, Postoperative

UNKNOWN NA

Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy

NCT03875664

Postoperative Pain

COMPLETED PHASE4

The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Abdominal Surgery

NCT07224711

Pain Post Operative Analgesia Opioid Consumption, Postoperative

NOT_YET_RECRUITING PHASE4

Pudendal Nerve Block in Vaginal Surgery

NCT04198714

Nerve Block Pain, Postoperative Pelvic Floor Disorders +3 more

COMPLETED NA

Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery

NCT03040011

Pelvic Organ Prolapse Surgery Postoperative Pain

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Management

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: Local Anesthesia

Standard of care with local anesthesia used during surgery

Group Type ACTIVE_COMPARATOR

Local anaesthetic

Intervention Type DRUG

Local anesthesia injections

Group 2: Local Anesthesia plus Pudendal Nerve Block

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

Group Type ACTIVE_COMPARATOR

Pudendal Nerve Block plus anesthesia

Intervention Type DRUG

Local anesthesia injections plus a pudendal nerve block

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Local anaesthetic

Local anesthesia injections

Intervention Type DRUG

Pudendal Nerve Block plus anesthesia

Local anesthesia injections plus a pudendal nerve block

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No