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Pudendal Nerve Block in Vaginal Surgery

Primary Purpose

Nerve Block, Pain, Postoperative, Pelvic Floor Disorders

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pudendal block
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nerve Block

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • MetroHealth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Pudendal block

Sham injection

Arm Description

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.

10cc normal saline. 5cc will be injected transvaginally in the area of the pudendal nerve on each side.

Outcomes

Primary Outcome Measures

Visual Analog Scores at 7am after surgery
Visual analog score: 0 (No pain) - 10 (The worst imaginable pain)

Secondary Outcome Measures

Visual analog scores at discharge from post-anesthesia care unit
Visual analog score: 0 (No pain) - 10 (The worst imaginable pain)
Pain Scores 96 hours after surgery
Numeric rating pain scale: 0 (No pain) - 10 (The worst imaginable pain)
Quality of Recovery scores on post op day 1 (7AM)
Quality of Recovery score: Part A 18 (very poor) - 90 (excellent); Part B 22 (excellent) - 110 (very poor)
Satisfaction scores in the morning after surgery (7AM)
Satisfaction with overall pain control: 0 (Not satisfied at all) - 10 (Extremely satisfied)
Satisfaction scores 96 hours after surgery
Satisfaction with overall pain control: 0 (Not satisfied at all) - 10 (Extremely satisfied)
Length of stay
Length of inpatient hospitalization after surgery
Opioid analgesic use in the post-anesthesia care unit
Total dose of opioids administered in the post-anesthesia care unit, in morphine equivalents.
Total postoperative opioid use
Total dose of opioids administered during the first 24 hours after surgery, in morphine equivalents.
Severity of postoperative non-pain symptoms
Quality of Recovery Score, Part B "Comfort": 8 (none of the time) - 40 (All of the time)
Postoperative bladder function.
Incidence of urinary retention
Postoperative bowel function.
Time to first bowel movement

Full Information

First Posted
December 10, 2019
Last Updated
April 20, 2022
Sponsor
MetroHealth Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04198714
Brief Title
Pudendal Nerve Block in Vaginal Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MetroHealth Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Block, Pain, Postoperative, Pelvic Floor Disorders, Pelvic Organ Prolapse, Pudendal Neuralgia, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, placebo-controlled randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pudendal block
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham injection
Arm Type
Sham Comparator
Arm Description
10cc normal saline. 5cc will be injected transvaginally in the area of the pudendal nerve on each side.
Intervention Type
Procedure
Intervention Name(s)
Pudendal block
Intervention Description
Administration of a pudendal block at the conclusion of vaginal surgery.
Primary Outcome Measure Information:
Title
Visual Analog Scores at 7am after surgery
Description
Visual analog score: 0 (No pain) - 10 (The worst imaginable pain)
Time Frame
Postoperative day 1 at 7am
Secondary Outcome Measure Information:
Title
Visual analog scores at discharge from post-anesthesia care unit
Description
Visual analog score: 0 (No pain) - 10 (The worst imaginable pain)
Time Frame
At the time of discharge from post-anesthesia care unit, on average 1-3 hours
Title
Pain Scores 96 hours after surgery
Description
Numeric rating pain scale: 0 (No pain) - 10 (The worst imaginable pain)
Time Frame
96 hours postoperatively
Title
Quality of Recovery scores on post op day 1 (7AM)
Description
Quality of Recovery score: Part A 18 (very poor) - 90 (excellent); Part B 22 (excellent) - 110 (very poor)
Time Frame
7am on postoperative day 1
Title
Satisfaction scores in the morning after surgery (7AM)
Description
Satisfaction with overall pain control: 0 (Not satisfied at all) - 10 (Extremely satisfied)
Time Frame
7am on postoperative day 1
Title
Satisfaction scores 96 hours after surgery
Description
Satisfaction with overall pain control: 0 (Not satisfied at all) - 10 (Extremely satisfied)
Time Frame
96 hours postoperatively
Title
Length of stay
Description
Length of inpatient hospitalization after surgery
Time Frame
Through the time of hospital discharge, on average 15-20 hours
Title
Opioid analgesic use in the post-anesthesia care unit
Description
Total dose of opioids administered in the post-anesthesia care unit, in morphine equivalents.
Time Frame
Through the time of discharge from the post-anesthesia care unit, on average 1-3 hours
Title
Total postoperative opioid use
Description
Total dose of opioids administered during the first 24 hours after surgery, in morphine equivalents.
Time Frame
Through the time of hospital discharge, on average 15-20 hours
Title
Severity of postoperative non-pain symptoms
Description
Quality of Recovery Score, Part B "Comfort": 8 (none of the time) - 40 (All of the time)
Time Frame
Postoperative day 1 (7AM)
Title
Postoperative bladder function.
Description
Incidence of urinary retention
Time Frame
Up to 96 hours after surgery
Title
Postoperative bowel function.
Description
Time to first bowel movement
Time Frame
Up to 96 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

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Pudendal Nerve Block in Vaginal Surgery

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