- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02658240
Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration
Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration for Pain Management After Total Hip Arthroplasty: A Randomized Controlled Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Despite substantial advances in our understanding of the pathophysiology of pain and availability of newer analgesic techniques, postoperative pain is not always effectively treated. Optimal pain management technique balances pain relief with concerns about safety and adverse effects associated with analgesic techniques. Currently, postoperative pain is commonly treated with systemic opioids, which are associated with numerous adverse effects including nausea and vomiting, dizziness, drowsiness, pruritus, urinary retention, and respiratory depression. Use of regional and local anesthesia has been shown to reduce opioid requirements and opioid-related side effects.
Patients undergoing total hip arthroplasty (THA) (n=60) at Parkland and UT Southwestern Medical Center Hospitals will be randomized into one of two groups to receive either ultrasound-guided fascia iliaca compartment block (FICB) with ropivacaine 300 mg and 0.5 mg epinephrine (Group 1) or periarticular infiltration ropivacaine 300 mg and 0.5 mg epinephrine total (Group 2) for postoperative pain management. The remaining aspect of perioperative care, including the anesthetic technique (i.e., spinal anesthetic), pre- and postoperative care will be standardized and will be similar for all patients. The duration of the involvement in the study will be until 48 hours postoperatively.
Patients in Group 1 will receive ultrasound-guided FICB after surgery. Patients in Group 2 will receive ropivacaine via periarticular infiltration prior to closing the incision.
The postoperative analgesia will be documented using the visual analog score (0=no pain, 10=worst pain). In addition, total opioid dose over the 48-h study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue antiemetics will be given to any patient who complains of nausea and/or vomiting. All variables will be assessed at 2, 6, 12, 24, and 48 hours, postoperatively by an investigator blinded to group allocation.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75390
- UTSW Parkland Health Hospital System
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Female ASA physical status 1-3 scheduled for total hip arthroplasty
- Age 18-80 years old
- Able to participate personally or by legal representative in informed consent in English or Spanish
Exclusion Criteria:
- History of relevant drug allergy
- Age less than 18 or greater than 80 years
- Chronic opioid use or drug abuse
- Significant psychiatric disturbance
- Inability to understand the study protocol
- Refusal to provide written consent
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Compartment Block
Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery
|
Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
0.5 mg epinephrine
Andra namn:
|
|
Aktiv komparator: Infiltration
Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision
|
Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
0.5 mg epinephrine
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative Pain Score at Resting
Tidsram: Postoperative 48 hours
|
The Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
|
Postoperative 48 hours
|
|
Postoperative Pain Score With Movement
Tidsram: Postoperative 48 hours
|
The Visual Analog Pain Score (VAS) with movement on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
|
Postoperative 48 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours
Tidsram: Postoperative 48 hours
|
Total amounts of postoperative opioid requirements for 48 hours postoperatively
|
Postoperative 48 hours
|
|
The Time to Ambulation
Tidsram: Postoperative 48 hours
|
The time to ambulation during 48 hours postoperative period
|
Postoperative 48 hours
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Irina Gasanova, MD, UT Southwestern Medical Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
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
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Postoperativa komplikationer
- Smärta
- Neurologiska manifestationer
- Smärta, postoperativt
- Läkemedels fysiologiska effekter
- Adrenerga medel
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Depressiva medel i centrala nervsystemet
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Sensoriska systemagenter
- Bedövningsmedel
- Adrenerga alfa-agonister
- Adrenerga agonister
- Anestesimedel, lokal
- Bronkdilaterande medel
- Anti-astmatiska medel
- Andningsorgan
- Adrenerga beta-agonister
- Sympatomimetika
- Vasokonstriktormedel
- Mydriatics
- Ropivakain
- Adrenalin
Andra studie-ID-nummer
- STU 122015-022
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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