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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLA | Experimental | Active preemptive local analgesia. |
|
| Placebo | Placebo Comparator | Placebo for preemptive local analgesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupivacaine and epinephrine | Drug | 20 ml of 0.5% bupivacaine with 1:200,000 epinephrine paracervical injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Score | Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points. | 30 minutes post-op |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime B. Long, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18830553 | Result | 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. |
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95 of the eligible patients consented to participate. 3 were excluded prior to treatment because they converted to abdominal hysterectomy. 2 were excluded because the study treatment was unintentionally missed by the operating staff.
Patients undergoing vaginal hysterectomy with McCall culdoplasty at the Mayo Clinic Hospital were recruited from 17 May 2006 to 14 February 2008. We screened 146 patients who were scheduled for vaginal surgery, and 142 were eligible to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Preemptive Local Analgesia (PLA) | Active preemptive local analgesia. |
| FG001 | Placebo | Placebo for preemptive local analgesia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preemptive Local Analgesia (PLA) | Active preemptive local analgesia. |
| BG001 | Placebo | Placebo for preemptive local analgesia. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analogue Scale (VAS) Pain Score | Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points. | Posted | Mean | Standard Deviation | points on a scale | 30 minutes post-op |
|
|
6 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preemptive Local Analgesia (PLA) | Active preemptive local analgesia. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michaele Menghini | Mayo Clinic | 480-301-6651 | menghini.michaele@mayo.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo | Drug | 20 ml normal saline injection. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| 5 |
| 45 |
| 18 |
| 45 |
| EG001 | Placebo | Placebo for preemptive local analgesia. | 3 | 45 | 22 | 45 |
| Bacterial Infection | Infections and infestations |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
|
| Postoperative Nausea and Vomiting Requiring Readmission | Gastrointestinal disorders |
|
| Postoperative Pain Requiring Readmission | Surgical and medical procedures |
|
| Pulmonary Embolism | Vascular disorders |
|
| Rectal Pain | Surgical and medical procedures |
|
| Urinary Retention | Renal and urinary disorders |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |