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

Primary Purpose

Pelvic Organ Prolapse

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pudendal block
no pudendal block
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pelvic Organ Prolapse focused on measuring pudendal nerve block, vaginal reconstructive surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

pudendal block

no pudendal block

Arm Description

preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine. 10 ml of Bupivacaine will be injected on either side using the pudendal nerve block tray.

Saline

Outcomes

Primary Outcome Measures

VAS pain scale

Secondary Outcome Measures

post operative analgesic consumption
adverse effect of the pudendal block
Length of hospital stay
Medical or surgical complications

Full Information

First Posted
April 1, 2015
Last Updated
April 23, 2017
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT02409498
Brief Title
Use of Pre-Emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery
Official Title
A Randomized Controlled Trial of Use of Pre-emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
pudendal nerve block, vaginal reconstructive surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pudendal block
Arm Type
Active Comparator
Arm Description
preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine. 10 ml of Bupivacaine will be injected on either side using the pudendal nerve block tray.
Arm Title
no pudendal block
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Drug
Intervention Name(s)
pudendal block
Other Intervention Name(s)
Bupivicaine, Marcaine
Intervention Description
preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine.
Intervention Type
Drug
Intervention Name(s)
no pudendal block
Other Intervention Name(s)
Saline, salt water, placebo
Intervention Description
preemptive pudendal nerve blockade with 10 ml of normal saline to each side
Primary Outcome Measure Information:
Title
VAS pain scale
Time Frame
up to 2 weeks
Secondary Outcome Measure Information:
Title
post operative analgesic consumption
Time Frame
up to 2 weeks
Title
adverse effect of the pudendal block
Time Frame
up to 2 weeks
Title
Length of hospital stay
Time Frame
up to 2 weeks
Title
Medical or surgical complications
Time Frame
up to 2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mamta Mamik, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1519781
Citation
Katz J, Kavanagh BP, Sandler AN, Nierenberg H, Boylan JF, Friedlander M, Shaw BF. Preemptive analgesia. Clinical evidence of neuroplasticity contributing to postoperative pain. Anesthesiology. 1992 Sep;77(3):439-46. doi: 10.1097/00000542-199209000-00006.
Results Reference
background
PubMed Identifier
9840560
Citation
Ke RW, Portera SG, Bagous W, Lincoln SR. A randomized, double-blinded trial of preemptive analgesia in laparoscopy. Obstet Gynecol. 1998 Dec;92(6):972-5. doi: 10.1016/s0029-7844(98)00303-2.
Results Reference
background
PubMed Identifier
3051873
Citation
Schierup L, Schmidt JF, Torp Jensen A, Rye BA. Pudendal block in vaginal deliveries. Mepivacaine with and without epinephrine. Acta Obstet Gynecol Scand. 1988;67(3):195-7. doi: 10.3109/00016348809004200.
Results Reference
background

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

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