- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
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Georgia
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Atlanta, Georgia, Forenede Stater, 30303
- Grady Memorial Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy women undergoing cesarean section
Exclusion Criteria:
- Any comorbidities other than obesity, hypertension, fetal anomalies
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Hydromorphone
Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally
|
Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Scores, Visual Analogue Pain Scale
Tidsramme: 12 hours after intrathecal injection
|
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
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12 hours after intrathecal injection
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Scores, Visual Analogue Pain Scale
Tidsramme: Baseline
|
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
|
Baseline
|
|
Pain Scores, Visual Analogue Pain Scale
Tidsramme: 6 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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6 hours after intrathecal injection
|
|
Pain Scores, Visual Analogue Pain Scale
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Grant C Lynde, MD, Emory University
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
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Postoperative komplikationer
- Smerte
- Neurologiske manifestationer
- Smerter, postoperativ
- Lægemidlers fysiologiske virkninger
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Analgetika, Opioid
- Narkotika
- Hydromorfon
Andre undersøgelses-id-numre
- IRB00058097
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