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Preemptive Local Anesthesia in Vaginal Surgery

NCT ID: NCT00318292

Last Updated: 2010-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-03-31

Brief Summary

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Preemptive analgesia is an intervention which provides an anesthetic prior to initiating a painful stimulus. This trial is examining the effects of a local anesthetic given at the point of innervation prior to performing a vaginal hysterectomy with suspension sutures.

Detailed Description

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Conditions

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Pain, Postoperative

Keywords

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preemptive analgesia paracervical block vaginal hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PLA

Active preemptive local analgesia.

Group Type EXPERIMENTAL

bupivacaine and epinephrine

Intervention Type DRUG

20 ml of 0.5% bupivacaine with 1:200,000 epinephrine paracervical injection.

Placebo

Placebo for preemptive local analgesia.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

20 ml normal saline injection.

Interventions

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bupivacaine and epinephrine

20 ml of 0.5% bupivacaine with 1:200,000 epinephrine paracervical injection.

Intervention Type DRUG

Placebo

20 ml normal saline injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women undergoing vaginal hysterectomy with McCall's culdoplasty
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Jaime B. Long, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Countries

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United States

References

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Long JB, Eiland RJ, Hentz JG, Mergens PA, Magtibay PM, Kho RM, Magrina JF, Cornella JL. Randomized trial of preemptive local analgesia in vaginal surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):5-10. doi: 10.1007/s00192-008-0716-6. Epub 2008 Oct 2.

Reference Type RESULT
PMID: 18830553 (View on PubMed)

Other Identifiers

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63-06

Identifier Type: -

Identifier Source: org_study_id