- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01449318
Predictors of Postoperative Pain
Predictors of Postoperative Pain Following Abdominal Hysterectomy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Beirut, Libanon
- AUBMC
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Beirut, Libanon
- American Unversity of Beirut Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients undergoing abdominal hysterectomy through a pfannenstiel incision
- American Society of Anesthesiologists (ASA)Class I-III
Exclusion Criteria:
- Patients with a history of psychiatric disease
- Diabetic or alcoholic patients who may have impaired sensation due peripheral neuropathies
- chronic opioid or nonsteroidal antiinflammatory drug use
- chronic pain conditions
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Patients undergoing hysterectomy
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Thermal stimuli will be administered to the ventral surface of the dominant forearm and then to the lower abdomen (surgical site)using the Thermal Sensory Analyser. Each thermal testing trial will be separated by approximately 2 min and at a separate site. To measure the thermal pain threshold temperature, The thermode will be applied to the ventral surface of the dominant forearm and the temperature will be increased at 1°C/s from 35 to 50°C. To measure the Suprathreshold Thermal Pain Intensity and unpleasantness, Stimulus responses for noxious heat stimuli will be performed by applying phasic heat stimuli at 8 different temperatures (35, 43, 44, 45, 46, 47, 48, and 49°C).
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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pain scores from IV insertion
Tidsramme: 15 minutes prior to induction
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15 minutes prior to induction
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Anxiety
Tidsramme: 24 to 48 hours before surgery
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24 to 48 hours before surgery
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Pain from thermal stimuli
Tidsramme: 24 to 48 hours before surgery
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Pain from thermal stimuli will be measure at two sites: site of surgery and at the forearm.
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24 to 48 hours before surgery
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Suprathreshold Thermal pain intensity
Tidsramme: 24 to 48 hours before surgery
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Suprathreshold Thermal pain intensity will be recorded at two site: site of surgery and forearm
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24 to 48 hours before surgery
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suprathreshold thermal unpleasantness intensity
Tidsramme: 24 to 48 hours before surgery
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24 to 48 hours before surgery
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Expectation about pain
Tidsramme: 24 to 48 hours before surgery
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24 to 48 hours before surgery
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postoperative pain
Tidsramme: within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery
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Postoperative pain will be measured upon arrival to the Post Anesthesia Care Unit (PACU)before morphine consumption and after morphine consumption, at rest and at movement.
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within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery
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Morphine consumption
Tidsramme: within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery
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within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Marie T Aouad, MD, American University of Beirut Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ANES.MA.13
- AUBMC (Anden identifikator: AUBMC)
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