Skip to content

Use of Pre-Emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery

A Randomized Controlled Trial of Use of Pre-emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02409498
Enrollment
0
Registered
2015-04-06
Start date
2015-10-31
Completion date
2015-10-31
Last updated
2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

pudendal nerve block, vaginal reconstructive surgery

Brief summary

The purpose of this study is to determine the effectiveness of perineal pain control via injection of a local anesthetic to numb the pudendal nerve. The medication which is commonly used for this block is called marcaine. This is called a pudendal block it has been used in obstetrical and gynecologic surgeries for several decades. The goal of this study is to reduce the amount of pain medications taken post operatively after pelvic reconstructive surgery. Subjects undergoing pelvic reconstructive surgery will be recruited during the pre-op visit. Subjects will be asked about their pain level in the PACU and also asked to document their pain score days 1 and 2 post op. They will also be asked to keep a medication log for 14 days post op.

Detailed description

Subjects will have a through physical exam with evolution of the pelvis support using the POP-Q (pelvic organ prolapse quantification) system. All subjects will need to sign informed consent pre-approved by the IRB. The subjects, surgeons, and anesthesiologist will all be blinded to the injected material. The OR Scrub nurse will given the envelope at the start of each case and asked to draw the material into a syringe. All subjects will receive general anesthesia. Subjects will be randomized to receive preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine or normal saline to each side. The allocation schedule is computer generated using random-numbers table concealed in opaque envelops. Once the patient receives general anesthesia she will be positioned appropriately in dorsal lithotomy with padded Allan stir ups. 10 ml of Bupivacaine will be injected on either side using the Iowa trumpet pudendal needle drive to direct and guide appropriate position. Aspiration was attempted for every injection to decrease the chance of intravascular infusion. At the completion of the surgery the subjects will be brought to the PACU for care. Patients are assessed immediately upon arrival to the PACU. The patients are asked their pain level using the VAS pain scale/ modified surgical pain scale at hours 1 and 2 post op. All patients are given a prescription for Vicoprofen 7.5/200mg at their pre-op visit and asked to have it filled prior to their surgery. Patients have the option to go home the same day of surgery as long as their pain is well controlled and they are clinically stable for discharge. Continued pain management and pain scale assessment will be done at 4 hours, and post op day 1 and 2. A medication log will be kept for 2 weeks post op, detailing the number of pain medications taken during that period.

Interventions

preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine.

DRUGno pudendal block

preemptive pudendal nerve blockade with 10 ml of normal saline to each side

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* The ability to read and understand English * Be at least 18 years old * Symptomatic Stage 2 prolapse

Exclusion criteria

* Intolerance to local anesthetics or narcotics * History of major psychiatric disorder or chronic pain syndrome * History of substance abuse or current narcotic use

Design outcomes

Primary

MeasureTime frame
VAS pain scaleup to 2 weeks

Secondary

MeasureTime frame
post operative analgesic consumptionup to 2 weeks
adverse effect of the pudendal blockup to 2 weeks
Length of hospital stayup to 2 weeks
Medical or surgical complicationsup to 2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026