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

NCT04690647 | Completed

• 1 other identifier: FasiaIliaca
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Local; Analgesia; Arthropathy of Hip

Outcome Measures

Primary Outcomes (3)

• Opioid consumption [mg]

  Postoperative opioid consumption was noted.

  48 hours

• Opioid related adverse effects

  Postoperative incidence of nausea, vomiting, constipation and apnea were noted.

  48 hours

• Hospital stay [days]

  Total length of hospital stay was noted.

  31 days

Secondary Outcomes (1)

• Likert scale

  31 days

Study Arms (3)

Opioid and non opioid postoperative analgesia.

PLACEBO COMPARATOR

Group of patients with opioid and non opioid based postoperative analgesia without preoperative regional anaesthesia and dexamethasone.

Other: Opioid and non opioid postoperative analgesia.

Regional anaesthesia, opioid and non opioid postoperative analgesia.

EXPERIMENTAL

Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and without preoperative dexamethasone.

Other: Opioid and non opioid postoperative analgesia.; Other: Fascia iliaca compartment block

Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia

EXPERIMENTAL

Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and dexamethasone.

Other: Opioid and non opioid postoperative analgesia.; Other: Fascia iliaca compartment block; Drug: Dexamethasone

Interventions

Opioid and non opioid postoperative analgesia. OTHER

Postoperative analgesia will be based on opioid and non opioid analgesics according to standardised protocol.

Opioid and non opioid postoperative analgesia.; Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia; Regional anaesthesia, opioid and non opioid postoperative analgesia.

Fascia iliaca compartment block OTHER

Ultrasound guided suprainguinal fascia iliaca compartment block will be performed using 0.375% ropivacaine and 5ug/ml adrenaline according to standardised protocol.

Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia; Regional anaesthesia, opioid and non opioid postoperative analgesia.

Dexamethasone DRUG

Dexamethasone will be administered preoperatively in a dose of 0,1 mg/kg.

Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Lucas Hospital, Poland: lead

Study Sites (1)

Saint Lucas Hospital

Gmina Końskie, Świętokrzyskie Voivodeship, 20-206, Poland

Location

Related Publications (1)

• Gola W, Bialka S, Owczarek AJ, Misiolek H. Effectiveness of Fascia Iliaca Compartment Block after Elective Total Hip Replacement: A Prospective, Randomized, Controlled Study. Int J Environ Res Public Health. 2021 May 4;18(9):4891. doi: 10.3390/ijerph18094891.

  PMID: 34064427 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Analgesics, Opioid; Dexamethasone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Wojciech Gola, MD

  Head of the Department of Anesthesia and Intensive Care Unit, Saint Lucas Hospital, Konskie, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Head of The Department of Anesthesia

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: December 31, 2020
• Study Start: September 28, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: December 31, 2020

Record last verified: 2020-12

Locations

PL (1)