Trial Outcomes & Findings for Pudendal Nerve Block in Vaginal Surgery (NCT NCT04198714)

NCT ID: NCT04198714

Last Updated: 2024-08-12

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: Postoperative day 1 at 7am
• Results posted on: 2024-08-12

Participant Flow

Participant milestones

Measure	Pudendal Block 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. Pudendal block: Administration of a pudendal block at the conclusion of vaginal surgery.	Placebo Injection 10cc normal saline. 5cc will be injected transvaginally in the area of the pudendal nerve on each side. Pudendal block: Administration of a pudendal block at the conclusion of vaginal surgery.
Overall Study STARTED	36	36
Overall Study COMPLETED	36	35
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Pudendal Block 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. Pudendal block: Administration of a pudendal block at the conclusion of vaginal surgery.	Placebo Injection 10cc normal saline. 5cc will be injected transvaginally in the area of the pudendal nerve on each side. Pudendal block: Administration of a pudendal block at the conclusion of vaginal surgery.
Overall Study Physician Decision	0	1

Baseline Characteristics

Pudendal Nerve Block in Vaginal Surgery

Baseline characteristics by cohort

Measure	Pudendal Block n=36 Participants Medication arm, received 9cc 0.5% bupivacaine + 1cc 40mg/cc triamcinolone 5 cc injected on each side	Placebo Injection n=35 Participants Placebo arm, received 10cc normal saline 5cc injected on each side	Total n=71 Participants Total of all reporting groups
Age, Continuous	60.69 years STANDARD_DEVIATION 10.41 • n=5 Participants	58.54 years STANDARD_DEVIATION 13.18 • n=7 Participants	59.89 years STANDARD_DEVIATION 11.943 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	28 Participants n=5 Participants	24 Participants n=7 Participants	52 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Note specified	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Obesity	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Tobacco use	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Chronic pain	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Preoperative diagnosis Pelvic organ prolapse	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants
Preoperative diagnosis Urinary incontinence	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Preoperative diagnosis Vaginal mesh exposure	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Preoperative diagnosis Uterine fibroids	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Surgery performed Vaginal hysterectomy	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Surgery performed Salpingectomy	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Surgery performed Uterosacral ligament suspension	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Surgery performed Sacrospinous ligament suspension	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Surgery performed A/P repair	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Surgery performed Trachelectomy	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Surgery performed Colpocleisis	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Surgery performed Vaginal mesh removal	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Surgery performed Midurethral sling	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Surgery performed Vaginal cuff repair	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Postoperative day 1 at 7am

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

Outcome measures

Measure	Pudendal Block n=34 Participants Medication arm, received 9cc 0.5% bupivacaine + 1cc 40mg/cc triamcinolone 5 cc injected on each side	Placebo Injection n=31 Participants Placebo arm, received 10cc normal saline 5cc injected on each side
Visual Analog Scores at 7am After Surgery	29.2 score on a scale Standard Deviation 21.5	42.6 score on a scale Standard Deviation 25.8

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Pudendal Block n=34 Participants Medication arm, received 9cc 0.5% bupivacaine + 1cc 40mg/cc triamcinolone 5 cc injected on each side	Placebo Injection n=34 Participants Placebo arm, received 10cc normal saline 5cc injected on each side
Visual Analog Scores at Discharge From Post-anesthesia Care Unit	53.1 score on a scale Standard Deviation 26.2	56.4 score on a scale Standard Deviation 27.6

SECONDARY outcome

Timeframe: 96 hours postoperatively

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

Outcome measures

Measure	Pudendal Block n=33 Participants Medication arm, received 9cc 0.5% bupivacaine + 1cc 40mg/cc triamcinolone 5 cc injected on each side	Placebo Injection n=32 Participants Placebo arm, received 10cc normal saline 5cc injected on each side
Pain Scores 96 Hours After Surgery	26.7 score on a scale Standard Deviation 21.8	35.5 score on a scale Standard Deviation 24.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Pudendal Block n=34 Participants Medication arm, received 9cc 0.5% bupivacaine + 1cc 40mg/cc triamcinolone 5 cc injected on each side	Placebo Injection n=32 Participants Placebo arm, received 10cc normal saline 5cc injected on each side
Quality of Recovery Scores on Post op Day 1 (7AM)	177.7 score on a scale Standard Deviation 13.95	172.3 score on a scale Standard Deviation 18.36

SECONDARY outcome

Timeframe: 7am on postoperative day 1

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

Outcome measures

Measure	Pudendal Block n=33 Participants Medication arm, received 9cc 0.5% bupivacaine + 1cc 40mg/cc triamcinolone 5 cc injected on each side	Placebo Injection n=31 Participants Placebo arm, received 10cc normal saline 5cc injected on each side
Satisfaction Scores in the Morning After Surgery (7AM)	81.5 score on a scale Standard Deviation 20.7	79.6 score on a scale Standard Deviation 26.8

SECONDARY outcome

Timeframe: 96 hours postoperatively

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

Outcome measures

Measure	Pudendal Block n=33 Participants Medication arm, received 9cc 0.5% bupivacaine + 1cc 40mg/cc triamcinolone 5 cc injected on each side	Placebo Injection n=32 Participants Placebo arm, received 10cc normal saline 5cc injected on each side
Satisfaction Scores 96 Hours After Surgery	80.5 score on a scale Standard Deviation 26.3	79.4 score on a scale Standard Deviation 25.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Pudendal Block n=36 Participants Medication arm, received 9cc 0.5% bupivacaine + 1cc 40mg/cc triamcinolone 5 cc injected on each side	Placebo Injection n=35 Participants Placebo arm, received 10cc normal saline 5cc injected on each side
Opioid Analgesic Use in the Post-anesthesia Care Unit	5 morphine milligram equivalents Standard Deviation 7.3	7.8 morphine milligram equivalents Standard Deviation 7.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Pudendal Block n=35 Participants Medication arm, received 9cc 0.5% bupivacaine + 1cc 40mg/cc triamcinolone 5 cc injected on each side	Placebo Injection n=34 Participants Placebo arm, received 10cc normal saline 5cc injected on each side
Total Postoperative Opioid Use	15 morphine milligram equivalents Standard Deviation 28.6	20.5 morphine milligram equivalents Standard Deviation 23.9

SECONDARY outcome

Timeframe: Postoperative day 1 (7AM)

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

Outcome measures

Measure	Pudendal Block n=34 Participants Medication arm, received 9cc 0.5% bupivacaine + 1cc 40mg/cc triamcinolone 5 cc injected on each side	Placebo Injection n=32 Participants Placebo arm, received 10cc normal saline 5cc injected on each side
Severity of Postoperative Non-pain Symptoms	37.2 score on a scale Standard Deviation 3.3	35.3 score on a scale Standard Deviation 5.6

SECONDARY outcome

Timeframe: Up to 96 hours after surgery

Incidence of urinary retention

Outcome measures

Measure	Pudendal Block n=36 Participants Medication arm, received 9cc 0.5% bupivacaine + 1cc 40mg/cc triamcinolone 5 cc injected on each side	Placebo Injection n=34 Participants Placebo arm, received 10cc normal saline 5cc injected on each side
Number of Participants With Postoperative Urinary Retention	7 Participants	4 Participants

Adverse Events

Pudendal Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey Mangel

MetroHealth Medical Center

Phone: 216-778-5595

Email: jmangel@metrohealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place