Ignite Creation Date:
2024-05-06 @ 3:55 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02409498
Status:
WITHDRAWN
Last Update Posted:
2017-04-25
First Post:
2015-04-01
Brief Title:
Use of Pre-Emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
A Randomized Controlled Trial of Use of Pre-emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery
Status:
WITHDRAWN
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 75200mg 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
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 75200mg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None