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Completed

NCT Number: NCT04198714

Pudendal Nerve Block in Vaginal Surgery

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.

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Key information

Conditions

Nerve Block Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nerve Compression Syndromes Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Floor Disorders Pelvic Organ Prolapse Peripheral Nervous System Diseases Postoperative Complications Pregnancy Complications Prolapse Pudendal Neuralgia Signs and Symptoms Surgery Urogenital Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Pudendal Block

Procedure

Administration of a pudendal block at the conclusion of vaginal surgery.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

    Visual analog score: 0 (No pain) - 100 (The worst imaginable pain)

  2. Pain Scores 96 Hours After Surgery

    Time frame: 96 hours postoperatively

    Numeric rating pain scale: 0 (No pain) - 100 (The worst imaginable pain)

  3. Quality of Recovery Scores on Post op Day 1 (7AM)

    Time frame: 7am on postoperative day 1

    Quality of Recovery is a global measure of quality of recovery. It is scored from 40-200. A higher score = better recovery.

  4. Satisfaction Scores in the Morning After Surgery (7AM)

    Time frame: 7am on postoperative day 1

    Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied)

  5. Satisfaction Scores 96 Hours After Surgery

    Time frame: 96 hours postoperatively

    Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied)

  6. 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 dose of opioids administered in the post-anesthesia care unit, in morphine equivalents.

  7. 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

    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.

  8. Severity of Postoperative Non-pain Symptoms

    Time frame: Postoperative day 1 (7AM)

    Quality of Recovery Score, Part B "Comfort". Scale 8-40, higher score = better recovery

  9. Number of Participants With Postoperative Urinary Retention

    Time frame: Up to 96 hours after surgery

    Incidence of urinary retention

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Registry information

Official study title

The Effect of Pudendal Nerve Block Analgesia on Postoperative Pain Control in Patients Undergoing Vaginal Surgery: A Randomized Double-blind Placebo-controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 13, 2019
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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