The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.

Analgesia Clinical Trial

Official title:

The Efficacy of Ultrasound Guided Suprainguinal Fascia Iliaca Compartment Block for Acute Paint Control After Elective Total Hip Replacement Using Postero-lateral Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690647
• Other study ID #: FasiaIliaca
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Analgesia
• Anesthesia, Local
• Arthropathy of Hip
• Joint Diseases

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