Nerve BlockNCT04198714
Pudendal Nerve Block in Vaginal Surgery
A study testing Pudendal block in people with Nerve Block and Pain, Postoperative, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
The objective of this this randomized controlled study is to determine whether a pudendal nerve block at the time of vaginal surgery is associated with improved postoperative pain control and decrease opioid consumption compared to a sham pudendal nerve block in patients undergoing vaginal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nerve Block, Pain, Postoperative, Pelvic Floor Disorders
- What is being tested?
- Pudendal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 13 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consenting, English speaking women between ages 18 and 80 who will undergo vaginal surgery
- Ability to read VAS Scores
- Specific vaginal procedures include, but are not limited to:
- Perineoplasty Complete vaginectomy Le Forte colpocleisis Anterior repair, posterior repair, and/or enterocele repair Transvaginal mesh use Transvaginal mesh excision Sacrospinous ligament fixation Uterosacral ligament suspension Vaginal paravaginal defect repair Midurethral sling placement Sphincteroplasty Vaginal hysterectomy, with or without removal of tube(s) and/or ovary(s), with or without repair of enterocele
Who cannot join
- History of chronic pelvic pain
- Currently taking sedatives
- Liver disease
- Renal disease
- Women who did not consent for the study.
- Intraoperative concern for increased blood loss
Show all 12Show fewer
- Unable to speak English
- Unable to understand VAS Scores
- Undergoing concomitant abdominal or laparoscopic procedures
- Allergy to bupivacaine or triamcinolone
- Planned abdominal or laparoscopic procedures.
- Patients who are ineligible for non-narcotic pain medications, such as an allergy to acetaminophen or NSAIDs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pudendal Nerve Block Analgesia on Postoperative Pain Control in Patients Undergoing Vaginal Surgery: A Randomized Double-blind Placebo-controlled Trial
The objective of this this randomized controlled study is to determine whether a pudendal nerve block at the time of vaginal surgery is associated with improved postoperative pain control and decrease opioid consumption compared to a sham pudendal nerve block in patients undergoing vaginal surgery.
- Conditions
- Nerve Block, Pain, Postoperative, Pelvic Floor Disorders, Pelvic Organ Prolapse, Pudendal Neuralgia, Surgery
- Being tested
- Pudendal block
- Medical subject headings
- Pain, Postoperative, Pelvic Floor Disorders, Pelvic Organ Prolapse, Pudendal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pudendal blockProcedure or surgery
Administration of a pudendal block at the conclusion of vaginal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pudendal block | Experimental | 9cc of 0.25% Marcaine + 1cc of 40mg/mL triamcinolone. 5cc will be injected transvaginally in the area of the pudendal nerve on each side. Receives: Procedure: Pudendal block |
| Placebo injection | Placebo comparator | 10cc normal saline. 5cc will be injected transvaginally in the area of the pudendal nerve on each side. Receives: Procedure: Pudendal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scores at 7am After Surgery
Visual analog score: 0 (No pain) - 100 (The worst imaginable pain)
Measured: Postoperative day 1 at 7am
Secondary outcomes (9)
Visual Analog Scores at Discharge From Post-anesthesia Care Unit
Visual analog score: 0 (No pain) - 100 (The worst imaginable pain)
Measured: At the time of discharge from post-anesthesia care unit, on average 1-3 hours from end of surgery
Pain Scores 96 Hours After Surgery
Numeric rating pain scale: 0 (No pain) - 100 (The worst imaginable pain)
Measured: 96 hours postoperatively
Quality of Recovery Scores on Post op Day 1 (7AM)
Quality of Recovery is a global measure of quality of recovery. It is scored from 40-200. A higher score = better recovery.
Measured: 7am on postoperative day 1
Satisfaction Scores in the Morning After Surgery (7AM)
Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied)
Measured: 7am on postoperative day 1
Satisfaction Scores 96 Hours After Surgery
Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied)
Measured: 96 hours postoperatively
Opioid Analgesic Use in the Post-anesthesia Care Unit
Total dose of opioids administered in the post-anesthesia care unit, in morphine equivalents.
Measured: Through the time of discharge from the post-anesthesia care unit, on average 1-3 hours from the end of surgery.
Total Postoperative Opioid Use
Total dose of opioids administered (in morphine equivalents) from time of arrival to the post-anesthesia care unit until either they were discharged from the hospital on POD#1 up to 24 hours postop OR if they were discharged on POD#0, the end timepoint was the time of the phone call on POD#1, up to 24 hours after surgery.
Measured: From the time a patient arrived in the post-anesthesia recovery unit until discharged from the hospital up to 24 hours OR time of their POD#1 phone call if discharged on same day as surgery up to 24 hours
Severity of Postoperative Non-pain Symptoms
Quality of Recovery Score, Part B "Comfort". Scale 8-40, higher score = better recovery
Measured: Postoperative day 1 (7AM)
Number of Participants With Postoperative Urinary Retention
Incidence of urinary retention
Measured: Up to 96 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Aug 2019
- Primary completion13 Sep 2021
- Study completion13 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198714
- Sponsor's protocol ID
- IRB18-00759
- Status last verified
- Mar 2024
- First submitted
- 10 Dec 2019
- Last updated
- 12 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Le Neveu M, Sears S, Rhodes S, Slopnick E, Petrikovets A, Mangel J, Sheyn D. The Impact of Pudendal Nerve Injection in Vaginal Surgery: A Secondary Analysis. Urogynecology (Phila). 2025 Sep 1;31(9):857-864. doi: 10.1097/SPV.0000000000001565.
PubMed 39733282Slopnick EA, Sears SB, Chapman GC, Sheyn DD, Abrams MK, Roberts KM, Pollard R, Mangel J. Pudendal Nerve Block Analgesia at the Time of Vaginal Surgery: A Randomized, Double-Blinded, Sham-Controlled Trial. Urogynecology (Phila). 2023 Oct 1;29(10):827-835. doi: 10.1097/SPV.0000000000001351. Epub 2023 Apr 4.
PubMed 37093572
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pudendal Nerve Block Analgesia on Postoperative Pain Control in Patients Undergoing Vaginal Surgery: A Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04198714
- Acronym / sponsor ID
- IRB18-00759
- Conditions
- Nerve Block, Pain, Postoperative, Pelvic Floor Disorders, Pelvic Organ Prolapse, Pudendal Neuralgia, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Posted 12 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this this randomized controlled study is to determine whether a pudendal nerve block at the time of vaginal surgery is associated with improved postoperative pain control and decrease opioid consumption compared to a sham pudendal nerve block in patients undergoing vaginal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pudendal block | Experimental | Procedure: Pudendal block9cc of 0.25% Marcaine + 1cc of 40mg/mL triamcinolone. 5cc will be injected transvaginally in the area of the pudendal nerve on each side. |
| Placebo injection | Placebo comparator | Procedure: Pudendal block10cc normal saline. 5cc will be injected transvaginally in the area of the pudendal nerve on each side. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consenting, English speaking women between ages 18 and 80 who will undergo vaginal surgery
- Ability to read VAS Scores
- Specific vaginal procedures include, but are not limited to:
- Perineoplasty Complete vaginectomy Le Forte colpocleisis Anterior repair, posterior repair, and/or enterocele repair Transvaginal mesh use Transvaginal mesh excision Sacrospinous ligament fixation Uterosacral ligament suspension Vaginal paravaginal defect repair Midurethral sling placement Sphincteroplasty Vaginal hysterectomy, with or without removal of tube(s) and/or ovary(s), with or without repair of enterocele
Key exclusion criteria (12 listed)
- History of chronic pelvic pain
- Currently taking sedatives
- Liver disease
- Renal disease
- Women who did not consent for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pudendal blockAdministration of a pudendal block at the conclusion of vaginal surgery. | Procedure or surgery | Placebo injection, Pudendal block |
Primary outcome
Visual Analog Scores at 7am After Surgery
Time frame: Postoperative day 1 at 7am
Visual analog score: 0 (No pain) - 100 (The worst imaginable pain)
9 secondary outcomes
Visual Analog Scores at Discharge From Post-anesthesia Care Unit
Time frame: At the time of discharge from post-anesthesia care unit, on average 1-3 hours from end of surgery
Pain Scores 96 Hours After Surgery
Time frame: 96 hours postoperatively
Quality of Recovery Scores on Post op Day 1 (7AM)
Time frame: 7am on postoperative day 1
Satisfaction Scores in the Morning After Surgery (7AM)
Time frame: 7am on postoperative day 1
Satisfaction Scores 96 Hours After Surgery
Time frame: 96 hours postoperatively
Opioid Analgesic Use in the Post-anesthesia Care Unit
Time frame: Through the time of discharge from the post-anesthesia care unit, on average 1-3 hours from the end of surgery.
Total Postoperative Opioid Use
Time frame: From the time a patient arrived in the post-anesthesia recovery unit until discharged from the hospital up to 24 hours OR time of their POD#1 phone call if discharged on same day as surgery up to 24 hours
Severity of Postoperative Non-pain Symptoms
Time frame: Postoperative day 1 (7AM)
Number of Participants With Postoperative Urinary Retention
Time frame: Up to 96 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39733282Le Neveu M, Sears S, Rhodes S, Slopnick E, Petrikovets A, Mangel J, Sheyn D. The Impact of Pudendal Nerve Injection in Vaginal Surgery: A Secondary Analysis. Urogynecology (Phila). 2025 Sep 1;31(9):857-864. doi: 10.1097/SPV.0000000000001565.
- Derived from this study: PubMed 37093572Slopnick EA, Sears SB, Chapman GC, Sheyn DD, Abrams MK, Roberts KM, Pollard R, Mangel J. Pudendal Nerve Block Analgesia at the Time of Vaginal Surgery: A Randomized, Double-Blinded, Sham-Controlled Trial. Urogynecology (Phila). 2023 Oct 1;29(10):827-835. doi: 10.1097/SPV.0000000000001351. Epub 2023 Apr 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pudendal block in people with Nerve Block and Pain, Postoperative, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scores at 7am After Surgery (time frame: Postoperative day 1 at 7am). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04198714, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.