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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04690647
Other study ID # FasiaIliaca
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 28, 2018
Est. completion date December 20, 2019

Study information

Verified date December 2020
Source Saint Lucas Hospital, Poland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Total hip replacement surgery is one of the most common orthopedic interventions. Proper anaesthesia and adequate analgesia is one of the key interests of attending anaesthetist. Recent studies show that ultrasound guided suprainguinal fascia iliaca compartment block may play a significant role in proper management of pain after these procedures. The aim of this study was to assess the clinical usefulness and compare different methods of anaesthesia for total hip replacement surgery via posterolateral approach.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date December 20, 2019
Est. primary completion date December 20, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - age 18-75 years old - informed consent to participate in the study - ASA score I-III - BMI -19-30kg/m2 - qualified for total hip replacement - no contraindication to used anesthesia and drugs Exclusion Criteria: - contraindications to spinal anesthesia and regional blocks - previously coexisting chronic pain - previously opioids intake - BMI>30kg/m2 - allergy to drugs using during study - mental status preventing the usage of patient controlled analgesia pump

Study Design


Intervention

Other:
Opioid and non opioid postoperative analgesia.
Postoperative analgesia will be based on opioid and non opioid analgesics according to standardised protocol.
Fascia iliaca compartment block
Ultrasound guided suprainguinal fascia iliaca compartment block will be performed using 0.375% ropivacaine and 5ug/ml adrenaline according to standardised protocol.
Drug:
Dexamethasone
Dexamethasone will be administered preoperatively in a dose of 0,1 mg/kg.

Locations

Country Name City State
Poland Saint Lucas Hospital Konskie Swietokrzyskie

Sponsors (1)

Lead Sponsor Collaborator
Saint Lucas Hospital, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid consumption [mg] Postoperative opioid consumption was noted. 48 hours
Primary Opioid related adverse effects Postoperative incidence of nausea, vomiting, constipation and apnea were noted. 48 hours
Primary Hospital stay [days] Total length of hospital stay was noted. 31 days
Secondary Likert scale Likert scale value was noted at the discharge. Value of 1 corresponded with strong dissatisfaction, value of 2 with dissatisfaction, value of 3 with neither satisfaction nor dissatisfaction, value of 4 with satisfaction, value of 5 with strong satisfaction. 31 days
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