- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01598545
Hydromorphone and C-section
Determination of the ED50 of Intrathecal Hydromorphone for Post-cesarean Section Pain Relief
This study will investigate the dose of hydromorphone which will relieve the pain of women following a cesarean section when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 3 out of 10 12 hours after intrathecal injection in 50% of women. Secondary objectives include determining the average amount of time patients obtain pain relief after injection. Other secondary objectives include determining the frequency and severity of side-effects associated with intrathecal administration of hydromorphone, including: bradycardia, hypotension, respiratory depression, apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted to labor and delivery for planned cesarean section desiring will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.
After the intrathecal injection is given, patients will undergo their cesarean section. The patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire. The patient's medical record will be reviewed to determine when she first requested supplemental pain medication. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be assessed.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
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Georgia
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Atlanta, Georgia, Förenta staterna, 30303
- Grady Memorial Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Healthy women undergoing cesarean section
Exclusion Criteria:
- Any comorbidities other than obesity, hypertension, fetal anomalies
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Hydromorphone
Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally
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Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain Scores, Visual Analogue Pain Scale
Tidsram: 12 hours after intrathecal injection
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Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
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12 hours after intrathecal injection
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain Scores, Visual Analogue Pain Scale
Tidsram: Baseline
|
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
|
Baseline
|
|
Pain Scores, Visual Analogue Pain Scale
Tidsram: 6 hours after intrathecal injection
|
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
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6 hours after intrathecal injection
|
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Pain Scores, Visual Analogue Pain Scale
Tidsram: 18 hours after intrathecal injection
|
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
|
18 hours after intrathecal injection
|
|
Pain Scores, Visual Analogue Pain Scale
Tidsram: 24 hours after intrathecal injection
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Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
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24 hours after intrathecal injection
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Grant C Lynde, MD, Emory University
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 (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00058097
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