- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00638404
Severity Postoperative Pain Prediction
Predicting Severity of Postoperative Pain After Surgery
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
The purpose of this study would be to determine the predictive value of a simple to perform preoperative evaluation in assessing level of anxiety, anticipated pain and the intensity rating of an audio tone to predict level of postoperative pain after surgery.
Study Design: A total of 400 evaluable patients will be studied using the various surgical populations listed. For statistical purposes, the following will be the surgical population by procedure. Two hundred healthy ASA I-II women scheduled for elective cesarean section, one hundred scheduled for elective postpartum tubal ligations, and one hundred scheduled for elective inpatient gynecological surgeries (such as total vaginal hysterectomy, total abdominal hysterectomy) will be consented and enrolled in the study. Normal baseline vital signs will be obtained and recorded as part of usual preoperative assessment for these patients. The patients will be asked about their current level of pain and to rate the intensity of a series of audio tones. At 18-24 hours postoperatively, and again at 36-48 hours postoperatively if applicable, research personnel will evaluate the severity of postoperative pain the patient has at rest and with movement (from supine to sitting upright), using a sliding pain scale from 0 to 100 mm, with 0 being no pain and 100 being the worst pain ever. Information on drug administered in the preoperative, intraoperative and postoperative period will be collected and recorded. The subject can also choose to allow us to follow-up with them in the future to evaluate current residual postoperative pain levels as needed.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
North Carolina
-
Winston-Salem, North Carolina, Förenta staterna, 27103
- Forsyth Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Healthy ASA physical status class 1 or 2
- Aged 18 years or above
- Pregnant with intrauterine pregnancy of at least 36 weeks for cesarean sections
Exclusion Criteria:
- ASA >3
- < 36 weeks for Cesarean Section
- < 18 years of age
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Övrig
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
|---|
|
1
Elective Cesarean Sections-this portion completed
|
|
3
Any in-patient gynecologic procedure- this portion completed
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evoked Pain at 24 Hours VAS
Tidsram: evoked pain at 24 hours
|
Outcome measure 0-100 Visual analog scale at 24 hours postoperatively, VAS of 0= no pain up to 100 =most severe pain
|
evoked pain at 24 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Anticipated Pain Medication Requirement
Tidsram: 24 hours
|
measured on a scale of 0-5, with 0=no anticipated pain medication needed up to 5 =most anticipated pain medication required
|
24 hours
|
|
Anticipated Postoperative Pain at Preoperative Evaluation
Tidsram: anticipated postoperative pain
|
anticipated postoperative pain on a scale of 0-100mm with 0=no anticipated pain at all up to 100= worst anticipated pain imaginable
|
anticipated postoperative pain
|
|
Anxiety
Tidsram: anticipated anxiety prior to surgery
|
measure of anticipated anxiety for on a scale of 0-100, with 0= not anxious at all up to 100 = most anxious
|
anticipated anxiety prior to surgery
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Peter H. Pan, MSEE, MD, Wake Forest University Health Sciences
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pain Prediction
Läkemedels- och apparatinformation, studiedokument
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