NCT02409498

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

Same day

First QC Date

April 1, 2015

Last Update Submit

April 23, 2017

Conditions

Pelvic Organ Prolapse

Keywords

pudendal nerve blockvaginal reconstructive surgery

Outcome Measures

Primary Outcomes (1)

  • VAS pain scale

    up to 2 weeks

Secondary Outcomes (4)

  • post operative analgesic consumption

    up to 2 weeks

  • adverse effect of the pudendal block

    up to 2 weeks

  • Length of hospital stay

    up to 2 weeks

  • Medical or surgical complications

    up to 2 weeks

Study Arms (2)

pudendal block

ACTIVE COMPARATOR

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.

Drug: pudendal block

no pudendal block

PLACEBO COMPARATOR

Saline

Drug: no pudendal block

Interventions

pudendal blockDRUG

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

Also known as: Bupivicaine, Marcaine
pudendal block
no pudendal blockDRUG

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

Also known as: Saline, salt water, placebo
no pudendal block

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (3)

  • 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.

    PMID: 1519781BACKGROUND

  • 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.

    PMID: 9840560BACKGROUND

  • 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.

    PMID: 3051873BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

BupivacaineSodium ChlorideFluoridation

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPreventive DentistryDentistryPublic Health DentistryEnvironment and Public Health

Study Officials

  • Mamta Mamik, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 6, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations

US(1)