Nerve Block, Pain, Postoperative, Pelvic Floor Disorders, Pelvic Organ Prolapse, Pudendal Neuralgia, Surgery
Conditions
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.
Interventions
PROCEDUREPudendal block
Administration of a pudendal block at the conclusion of vaginal surgery.
Sponsors
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double-blind, placebo-controlled randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scores at 7am After Surgery | Postoperative day 1 at 7am | Visual analog score: 0 (No pain) - 100 (The worst imaginable pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scores at Discharge From Post-anesthesia Care Unit | 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) |
| Quality of Recovery Scores on Post op Day 1 (7AM) | 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. |
| Satisfaction Scores in the Morning After Surgery (7AM) | 7am on postoperative day 1 | Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied) |
| Satisfaction Scores 96 Hours After Surgery | 96 hours postoperatively | Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied) |
| Pain Scores 96 Hours After Surgery | 96 hours postoperatively | Numeric rating pain scale: 0 (No pain) - 100 (The worst imaginable pain) |
| Total Postoperative Opioid Use | 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. |
| Severity of Postoperative Non-pain Symptoms | Postoperative day 1 (7AM) | Quality of Recovery Score, Part B Comfort. Scale 8-40, higher score = better recovery |
| Number of Participants With Postoperative Urinary Retention | Up to 96 hours after surgery | Incidence of urinary retention |
| Opioid Analgesic Use in the Post-anesthesia Care Unit | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pudendal Block Medication arm, received 9cc 0.5% bupivacaine + 1cc 40mg/cc triamcinolone 5 cc injected on each side | 36 |
| Placebo Injection Placebo arm, received 10cc normal saline 5cc injected on each side | 35 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo Injection | Total | Pudendal Block |
|---|---|---|---|
| Age, Continuous | 58.54 years STANDARD_DEVIATION 13.18 | 59.89 years STANDARD_DEVIATION 11.943 | 60.69 years STANDARD_DEVIATION 10.41 |
| Chronic pain | 7 Participants | 13 Participants | 6 Participants |
| Obesity | 15 Participants | 27 Participants | 12 Participants |
| Preoperative diagnosis Pelvic organ prolapse | 35 Participants | 68 Participants | 33 Participants |
| Preoperative diagnosis Urinary incontinence | 14 Participants | 32 Participants | 18 Participants |
| Preoperative diagnosis Uterine fibroids | 0 Participants | 2 Participants | 2 Participants |
| Preoperative diagnosis Vaginal mesh exposure | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity American Indian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 8 Participants | 13 Participants | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Note specified | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 24 Participants | 52 Participants | 28 Participants |
| Sex: Female, Male Female | 35 Participants | 71 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Surgery performed A/P repair | 20 Participants | 43 Participants | 23 Participants |
| Surgery performed Colpocleisis | 2 Participants | 5 Participants | 3 Participants |
| Surgery performed Midurethral sling | 13 Participants | 28 Participants | 15 Participants |
| Surgery performed Sacrospinous ligament suspension | 13 Participants | 24 Participants | 11 Participants |
| Surgery performed Salpingectomy | 14 Participants | 30 Participants | 16 Participants |
| Surgery performed Trachelectomy | 1 Participants | 1 Participants | 0 Participants |
| Surgery performed Uterosacral ligament suspension | 17 Participants | 33 Participants | 16 Participants |
| Surgery performed Vaginal cuff repair | 0 Participants | 1 Participants | 1 Participants |
| Surgery performed Vaginal hysterectomy | 18 Participants | 39 Participants | 21 Participants |
| Surgery performed Vaginal mesh removal | 0 Participants | 1 Participants | 1 Participants |
| Tobacco use | 4 Participants | 7 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 36 |
| other Total, other adverse events | 0 / 36 | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
Primary
Visual Analog Scores at 7am After Surgery
Visual analog score: 0 (No pain) - 100 (The worst imaginable pain)
Time frame: Postoperative day 1 at 7am
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Pudendal Block | Visual Analog Scores at 7am After Surgery | 29.2 score on a scale | Standard Deviation 21.5 |
| Placebo Injection | Visual Analog Scores at 7am After Surgery | 42.6 score on a scale | Standard Deviation 25.8 |
Secondary
Number of Participants With Postoperative Urinary Retention
Incidence of urinary retention
Time frame: Up to 96 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pudendal Block | Number of Participants With Postoperative Urinary Retention | 7 Participants |
| Placebo Injection | Number of Participants With Postoperative Urinary Retention | 4 Participants |
Secondary
Opioid Analgesic Use in the Post-anesthesia Care Unit
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 from the end of surgery.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Pudendal Block | Opioid Analgesic Use in the Post-anesthesia Care Unit | 5 morphine milligram equivalents | Standard Deviation 7.3 |
| Placebo Injection | Opioid Analgesic Use in the Post-anesthesia Care Unit | 7.8 morphine milligram equivalents | Standard Deviation 7.3 |
Secondary
Pain Scores 96 Hours After Surgery
Numeric rating pain scale: 0 (No pain) - 100 (The worst imaginable pain)
Time frame: 96 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pudendal Block | Pain Scores 96 Hours After Surgery | 26.7 score on a scale | Standard Deviation 21.8 |
| Placebo Injection | Pain Scores 96 Hours After Surgery | 35.5 score on a scale | Standard Deviation 24.3 |
Secondary
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.
Time frame: 7am on postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pudendal Block | Quality of Recovery Scores on Post op Day 1 (7AM) | 177.7 score on a scale | Standard Deviation 13.95 |
| Placebo Injection | Quality of Recovery Scores on Post op Day 1 (7AM) | 172.3 score on a scale | Standard Deviation 18.36 |
Secondary
Satisfaction Scores 96 Hours After Surgery
Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied)
Time frame: 96 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pudendal Block | Satisfaction Scores 96 Hours After Surgery | 80.5 score on a scale | Standard Deviation 26.3 |
| Placebo Injection | Satisfaction Scores 96 Hours After Surgery | 79.4 score on a scale | Standard Deviation 25.9 |
Secondary
Satisfaction Scores in the Morning After Surgery (7AM)
Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied)
Time frame: 7am on postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pudendal Block | Satisfaction Scores in the Morning After Surgery (7AM) | 81.5 score on a scale | Standard Deviation 20.7 |
| Placebo Injection | Satisfaction Scores in the Morning After Surgery (7AM) | 79.6 score on a scale | Standard Deviation 26.8 |
Secondary
Severity of Postoperative Non-pain Symptoms
Quality of Recovery Score, Part B Comfort. Scale 8-40, higher score = better recovery
Time frame: Postoperative day 1 (7AM)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pudendal Block | Severity of Postoperative Non-pain Symptoms | 37.2 score on a scale | Standard Deviation 3.3 |
| Placebo Injection | Severity of Postoperative Non-pain Symptoms | 35.3 score on a scale | Standard Deviation 5.6 |
Secondary
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.
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
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Pudendal Block | Total Postoperative Opioid Use | 15 morphine milligram equivalents | Standard Deviation 28.6 |
| Placebo Injection | Total Postoperative Opioid Use | 20.5 morphine milligram equivalents | Standard Deviation 23.9 |
Secondary
Visual Analog Scores at Discharge From Post-anesthesia Care Unit
Visual analog score: 0 (No pain) - 100 (The worst imaginable pain)
Time frame: At the time of discharge from post-anesthesia care unit, on average 1-3 hours from end of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pudendal Block | Visual Analog Scores at Discharge From Post-anesthesia Care Unit | 53.1 score on a scale | Standard Deviation 26.2 |
| Placebo Injection | Visual Analog Scores at Discharge From Post-anesthesia Care Unit | 56.4 score on a scale | Standard Deviation 27.6 |