Trial · NCT03040011

Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery

NCT03040011, Phase 1, Phase 2, Completed, Lauren Giugale, MD; results first posted 2020-03-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery. Trials, record NCT03040011. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03040011

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery
NCT number: NCT03040011
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 79 participants, actual
Lead sponsor: Lauren Giugale, MD
Conditions: Pelvic Organ Prolapse, Surgery, Postoperative Pain
Interventions: Dexamethasone, Bupivacaine, Bilateral Pudendal Nerve Block, Bilateral Levator Ani Muscle Injection, Saline
First posted: 2017-02-01
Last updated: 2020-03-09
Results first posted: 2020-03-09

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)	24 hours postoperatively	Postoperative pain measured by the numerical rating scale (NRS) at 24 hours postoperatively. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
Secondary	6 Hour Postoperative Pain Measured by the NRS	6 hours postoperatively	Postoperative pain as measured by the NRS at 6 hours after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain. Of note, there is a typographical error in the protocol section and refers to this outcome as a NRS score at 3 hours postoperatively. The final IRB approved protocol is a 6 hour postoperative timepoint and this is the correct outcome reported here in the results section.
Secondary	POD 2 Postoperative Pain Measured by the NRS	2 days after surgery	Postoperative Pain Measured by the NRS 2 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
Secondary	POD 3 Postoperative Pain Measured by the NRS	3 days after surgery	Postoperative Pain Measured by the NRS 3 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
Secondary	1 Week Postoperative Pain Measured by the NRS	1 week after surgery	Postoperative Pain Measured by the Numeric Rating Scale 1 week after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
Secondary	Proportion of Patients With Same Day Discharge	Day of surgery	Same day discharge was defined as a patient being discharged on the same day as surgery and did not require an admission after surgery. The proportion of patients who were discharged on the day of surgery was compared between groups.
Secondary	Postoperative Urinary Retention	0-24 hours postoperatively	Urinary retention was defined as the need to perform self-catheterization or have an indwelling catheter placed postoperatively. The proportion of patients with urinary retention was compared between groups.
Secondary	Adverse Events	0-12 weeks postoperatively	The number of adverse events in each study group was assessed and compared between study groups. An adverse event was described as any medical or surgical complication that occurred either intraoperatively or postoperatively.
Secondary	Nausea and Vomiting Measured by the PONV Scale	6 hours postoperatively	Intensity of postoperative nausea and vomiting (PONV) measured by the PONV scale prior to discharge. The Postoperative Nausea and Vomiting Intensity Scale is a four-question assessment to measure clinically significant nausea and vomiting with a range from 0-7 with higher scores signifying more clinically significant nausea and vomiting.
Secondary	Anti-emetic Consumption	3 hours postoperatively	The amount of inpatient anti-emetic consumption, recorded in number of doses of nausea medication

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)	24 hours postoperatively		score on a scale	MEDIAN
SECONDARY	6 Hour Postoperative Pain Measured by the NRS	6 hours postoperatively		score on a scale	MEDIAN
SECONDARY	POD 2 Postoperative Pain Measured by the NRS	2 days after surgery		score on a scale	MEDIAN
SECONDARY	POD 3 Postoperative Pain Measured by the NRS	3 days after surgery		score on a scale	MEDIAN
SECONDARY	1 Week Postoperative Pain Measured by the NRS	1 week after surgery		score on a scale	MEDIAN
SECONDARY	Proportion of Patients With Same Day Discharge	Day of surgery		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Postoperative Urinary Retention	0-24 hours postoperatively		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Adverse Events	0-12 weeks postoperatively		number of adverse events	NUMBER
SECONDARY	Nausea and Vomiting Measured by the PONV Scale	6 hours postoperatively		score on a scale	MEDIAN
SECONDARY	Anti-emetic Consumption	3 hours postoperatively	This data was not collected. Rather, we assessed the PONV score which is described in outcome number 9.

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group57

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)	Bupivacaine/Dexamethasone Arm	3.0	Inter-Quartile Range 1.0 to 5.0	score on a scale
Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)	Bupivacaine Arm	4.0	Inter-Quartile Range 2.0 to 5.0	score on a scale
Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)	Placebo Arm	3.75	Inter-Quartile Range 2.0 to 6.5	score on a scale
6 Hour Postoperative Pain Measured by the NRS	Bupivacaine/Dexamethasone Arm	1.0	Inter-Quartile Range 0.5 to 4.0	score on a scale
6 Hour Postoperative Pain Measured by the NRS	Bupivacaine Arm	3.0	Inter-Quartile Range 2.0 to 4.0	score on a scale
6 Hour Postoperative Pain Measured by the NRS	Placebo Arm	1.75	Inter-Quartile Range 0.6 to 4.0	score on a scale
POD 2 Postoperative Pain Measured by the NRS	Bupivacaine/Dexamethasone Arm	3.0	Inter-Quartile Range 1.0 to 5.0	score on a scale
POD 2 Postoperative Pain Measured by the NRS	Bupivacaine Arm	3.0	Inter-Quartile Range 2.0 to 4.0	score on a scale
POD 2 Postoperative Pain Measured by the NRS	Placebo Arm	4.0	Inter-Quartile Range 2.8 to 6.0	score on a scale
POD 3 Postoperative Pain Measured by the NRS	Bupivacaine/Dexamethasone Arm	3.0	Inter-Quartile Range 2.0 to 5.0	score on a scale

1 to 10 of 57Source ClinicalTrials.gov

See all 57 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Received Randomized Study Intervention	STARTED	Bupivacaine/Dexamethasone Arm	25
Received Randomized Study Intervention	STARTED	Bupivacaine Arm	25
Received Randomized Study Intervention	STARTED	Placebo Arm	25
Received Randomized Study Intervention	COMPLETED	Bupivacaine/Dexamethasone Arm	25
Received Randomized Study Intervention	COMPLETED	Bupivacaine Arm	25
Received Randomized Study Intervention	COMPLETED	Placebo Arm	25
Received Randomized Study Intervention	NOT COMPLETED	Bupivacaine/Dexamethasone Arm	0
Received Randomized Study Intervention	NOT COMPLETED	Bupivacaine Arm	0
Received Randomized Study Intervention	NOT COMPLETED	Placebo Arm	0
Primary Outcome Follow Up	STARTED	Bupivacaine/Dexamethasone Arm	25

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events33

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Urinary tract infection	Renal and urinary disorders	Bupivacaine/Dexamethasone Arm	2	25	2
other	Urinary tract infection	Renal and urinary disorders	Bupivacaine Arm	1	25	1
other	Urinary tract infection	Renal and urinary disorders	Placebo Arm	2	25	2
other	Excess postoperative surgical pain	Nervous system disorders	Bupivacaine/Dexamethasone Arm	1	25	1
other	Excess postoperative surgical pain	Nervous system disorders	Bupivacaine Arm	1	25	1
other	Excess postoperative surgical pain	Nervous system disorders	Placebo Arm	2	25	2
other	Intraoperative bradycardia	Cardiac disorders	Bupivacaine/Dexamethasone Arm	0	25	0
other	Intraoperative bradycardia	Cardiac disorders	Bupivacaine Arm	0	25	0
other	Intraoperative bradycardia	Cardiac disorders	Placebo Arm	1	25	1
other	Leg numbness	Nervous system disorders	Bupivacaine/Dexamethasone Arm	2	25	2

1 to 10 of 33Source ClinicalTrials.gov

See all 33 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bupivacaine/Dexamethasone Arm	0	25
Total, all-cause mortality	Bupivacaine Arm	0	25
Total, all-cause mortality	Placebo Arm	0	25
Total, other adverse events	Bupivacaine/Dexamethasone Arm	6	25
Total, other adverse events	Bupivacaine Arm	6	25
Total, other adverse events	Placebo Arm	7	25
Total, serious adverse events	Bupivacaine/Dexamethasone Arm	1	25
Total, serious adverse events	Bupivacaine Arm	0	25
Total, serious adverse events	Placebo Arm	2	25

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33278291	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03040011

GET https://conductscience.org/api/trials/v1/NCT03040011/results?page=2

API reference For AI assistants