Trial Outcomes & Findings for Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery (NCT NCT03040011)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

79 participants

Primary outcome timeframe

24 hours postoperatively

Results posted on

2020-03-09

Participant Flow

After enrollment but before randomization, 4 patients withdrew from the study: surgical location changed (n=1), declined to participate (n=1), unsafe for general anesthesia (n=1), reported lidocaine allergy (n=1). Because they withdrew prior to randomization, we received permission to enroll an additional 4 patients to meet goal sample size of 75.

Participant milestones

Participant milestones
Measure	Bupivacaine/Dexamethasone Arm After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	Bupivacaine Arm After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	Placebo Arm After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Received Randomized Study Intervention STARTED	25	25	25
Received Randomized Study Intervention COMPLETED	25	25	25
Received Randomized Study Intervention NOT COMPLETED	0	0	0
Primary Outcome Follow Up STARTED	25	25	25
Primary Outcome Follow Up COMPLETED	21	24	24
Primary Outcome Follow Up NOT COMPLETED	4	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Outcome measures
Measure	Bupivacaine/Dexamethasone Arm n=25 Participants After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	Bupivacaine Arm n=25 Participants After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	Placebo Arm n=25 Participants After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Nausea and Vomiting Measured by the PONV Scale	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 3 hours postoperatively

Bupivacaine/Dexamethasone Arm

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Bupivacaine Arm

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo Arm

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bupivacaine/Dexamethasone Arm n=25 participants at risk After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	Bupivacaine Arm n=25 participants at risk After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	Placebo Arm n=25 participants at risk After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Injury, poisoning and procedural complications Surgical complications	4.0% 1/25 • Number of events 1 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	4.0% 1/25 • Number of events 1 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.
Respiratory, thoracic and mediastinal disorders Asthma exacerbation	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	4.0% 1/25 • Number of events 1 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.

Other adverse events

Other adverse events
Measure	Bupivacaine/Dexamethasone Arm n=25 participants at risk After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	Bupivacaine Arm n=25 participants at risk After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	Placebo Arm n=25 participants at risk After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Renal and urinary disorders Urinary tract infection	8.0% 2/25 • Number of events 2 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	4.0% 1/25 • Number of events 1 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	8.0% 2/25 • Number of events 2 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.
Nervous system disorders Excess postoperative surgical pain	4.0% 1/25 • Number of events 1 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	4.0% 1/25 • Number of events 1 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	8.0% 2/25 • Number of events 2 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.
Cardiac disorders Intraoperative bradycardia	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	4.0% 1/25 • Number of events 1 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.
Nervous system disorders Leg numbness	8.0% 2/25 • Number of events 2 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	4.0% 1/25 • Number of events 1 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.
Gastrointestinal disorders Nausea and vomiting, diarrhea	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	8.0% 2/25 • Number of events 2 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.
Infections and infestations Fever	4.0% 1/25 • Number of events 1 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.
Musculoskeletal and connective tissue disorders Fall	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	4.0% 1/25 • Number of events 1 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.
Infections and infestations Yeast Infection	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	4.0% 1/25 • Number of events 1 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.
Infections and infestations Wound infection	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	4.0% 1/25 • Number of events 1 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.	0.00% 0/25 • 12 weeks from the date of surgery Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.

Additional Information

Dr. Lauren Giugale, PI

Magee-Womens Hospital of UPMC

Phone: 412-641-1498

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Bupivacaine/Dexamethasone Arm n=25 Participants After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	Bupivacaine Arm n=25 Participants After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	Placebo Arm n=25 Participants After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx	Total n=75 Participants Total of all reporting groups
Age, Continuous	68.8 years STANDARD_DEVIATION 13.6 • n=25 Participants	68.0 years STANDARD_DEVIATION 10.1 • n=25 Participants	70.2 years STANDARD_DEVIATION 9.2 • n=25 Participants	69.0 years STANDARD_DEVIATION 11.0 • n=75 Participants
Sex: Female, Male Female	25 Participants n=25 Participants	25 Participants n=25 Participants	25 Participants n=25 Participants	75 Participants n=75 Participants
Sex: Female, Male Male	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=75 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=75 Participants
Race (NIH/OMB) Asian	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=75 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=75 Participants
Race (NIH/OMB) Black or African American	2 Participants n=25 Participants	4 Participants n=25 Participants	0 Participants n=25 Participants	6 Participants n=75 Participants
Race (NIH/OMB) White	22 Participants n=25 Participants	21 Participants n=25 Participants	24 Participants n=25 Participants	67 Participants n=75 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=75 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=25 Participants	0 Participants n=25 Participants	1 Participants n=25 Participants	2 Participants n=75 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	25 participants n=25 Participants	25 participants n=25 Participants	25 participants n=25 Participants	75 participants n=75 Participants
Baseline NRS Pain Score	0 units on a scale n=25 Participants	0 units on a scale n=25 Participants	0 units on a scale n=25 Participants	0 units on a scale n=75 Participants
Baseline NV Score	0 units on a scale n=25 Participants	0 units on a scale n=25 Participants	0 units on a scale n=25 Participants	0 units on a scale n=75 Participants
Baseline AAS Score	94.6 units on a scale n=25 Participants	92.3 units on a scale n=25 Participants	95.5 units on a scale n=25 Participants	94.2 units on a scale n=75 Participants
Prolapse Procedure Uterosacral Ligament Suspension	4 Participants n=25 Participants	8 Participants n=25 Participants	11 Participants n=25 Participants	23 Participants n=75 Participants
Prolapse Procedure Sacrospinous Ligament Fixation	2 Participants n=25 Participants	3 Participants n=25 Participants	3 Participants n=25 Participants	8 Participants n=75 Participants
Prolapse Procedure Colpocleisis	14 Participants n=25 Participants	9 Participants n=25 Participants	7 Participants n=25 Participants	30 Participants n=75 Participants
Prolapse Procedure Levator Myorrhaphy	5 Participants n=25 Participants	5 Participants n=25 Participants	4 Participants n=25 Participants	14 Participants n=75 Participants