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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Local Anesthesia | Active Comparator | Standard of care with local anesthesia used during surgery |
|
| Group 2: Local Anesthesia plus Pudendal Nerve Block | Active Comparator | Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local anaesthetic | Drug | Local anesthesia injections |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Average pain score by Numerical Rating Scale (NRS). The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). | 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours, 24 hours, and 48 hours after surgery |
| Return to Normal Daily Activities |
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Inclusion Criteria:
Exclusion Criteria:
Women over the age of 18 undergoing vaginal reconstructive surgery without a hysterectomy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38640500 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Local Anesthesia | Standard of care with local anesthesia used during surgery Local anaesthetic: Local anesthesia injections |
| FG001 | Group 2: Local Anesthesia Plus Pudendal Nerve Block | Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery Pudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Local Anesthesia | This group was assigned usual care, which involved local anesthesia administered per surgeon preference |
| BG001 | Group 2: Local Anesthesia Plus Pudendal Nerve Block |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Narcotic Use | Measured in morphine milligram equivalents (MME) at 24 hours | Posted | Median | Inter-Quartile Range | MME | 24 hours after surgery |
|
6 weeks postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Local Anesthesia | Standard of care with local anesthesia used during surgery Local anaesthetic: Local anesthesia injections |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospital readmission | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pudendal nerve entrapment | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tamara Grisales, MD | University of California, Los Angeles | 310-983-1023 | tgrisales@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2020 | Nov 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| D000758 | Anesthesia |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000760 | Anesthesia and Analgesia |
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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).
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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
| Pudendal Nerve Block plus anesthesia |
| Drug |
Local anesthesia injections plus a pudendal nerve block |
|
Days to return to normal activity, defined as walking, sitting, and performing daily household tasks comfortably. Upon discharge, all participants received a diary to record the date they returned to normal daily activities. Participants were contacted at 2 and 6 weeks postoperatively either by telephone or during their scheduled office visit and were asked about their time to return to normal activity. |
| 6 weeks after surgery |
| Patient Satisfaction With Postoperative Recovery | Satisfaction with postoperative pain control was assessed using a verbal scale of 1=very satisfied, 2=Somewhat satisfied, 3=Neither satisfied nor dissatisfied, 4=Somewhat dissatisfied, 5=very dissatisfied | 48 hours after surgery, 2 weeks after surgery |
| Length of Hospital Stay | Tracked in hours | Tracked by hour through time of patient discharge (up to 72 hours) |
Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery
Pudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Narcotic Use | Measured in MME at 48 hours | Posted | Median | Inter-Quartile Range | MME | 48 hours after surgery |
|
|
|
| Secondary | Pain Scores | Average pain score by Numerical Rating Scale (NRS). The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). | Patients were not present for 8-12 hour assessment (outpatient surgery so they were sent home) | Posted | Mean | Standard Deviation | score on a scale | 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours, 24 hours, and 48 hours after surgery |
|
|
|
| Secondary | Return to Normal Daily Activities | Days to return to normal activity, defined as walking, sitting, and performing daily household tasks comfortably. Upon discharge, all participants received a diary to record the date they returned to normal daily activities. Participants were contacted at 2 and 6 weeks postoperatively either by telephone or during their scheduled office visit and were asked about their time to return to normal activity. | Posted | Median | Inter-Quartile Range | Days | 6 weeks after surgery |
|
|
|
| Secondary | Patient Satisfaction With Postoperative Recovery | Satisfaction with postoperative pain control was assessed using a verbal scale of 1=very satisfied, 2=Somewhat satisfied, 3=Neither satisfied nor dissatisfied, 4=Somewhat dissatisfied, 5=very dissatisfied | Participants who completed the study, per Participant Flow. | Posted | Count of Participants | Participants | 48 hours after surgery, 2 weeks after surgery |
|
|
|
| Secondary | Length of Hospital Stay | Tracked in hours | Posted | Median | Inter-Quartile Range | Hours | Tracked by hour through time of patient discharge (up to 72 hours) |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 6 |
| 22 |
| EG001 | Group 2: Local Anesthesia Plus Pudendal Nerve Block | Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery Pudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block | 0 | 22 | 1 | 22 | 7 | 22 |
| Postoperative nausea | General disorders | Systematic Assessment |
|
| Anesthetic complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Urinary retention at 48hr | Renal and urinary disorders | Systematic Assessment |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 2-4 hours |
|
|
| 4-8 hours |
|
|
| 8-12 hours |
|
| 24 hours |
|
|
| 48 hours |
|
|
| 3 - at 48 hours |
|
| 4 - at 48 hours |
|
| 5 - at 48 hours |
|
| Not obtained at 48 hours |
|
| 1 - at 2 weeks |
|
| 2 - at 2 weeks |
|
| 3 - at 2 weeks |
|
| 4 - at 2 weeks |
|
| 5 - at 2 weeks |
|
| Not obtained at 2 weeks |
|