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OpenTrials
Completed

NCT Number: NCT05621161

ESPB vs FICB for Pain Management Following Total Hip Prosthesis Surgery

Hip arthroplasty surgery is frequently performed on elderly patients in the community and it is associated with long-term postoperative hospital stays and high mortality.

Postoperative pain management is a multimodal process that includes intravenous and regional anesthesia methods. The ultrasound(US) guided erector spinae plane block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. In the literature, it has been reported that ESPB provides effective analgesia after a hip surgery. The fascia iliaca compartment block (FICB) is a safe method used for postoperative analgesia following hip, femoral, and knee surgeries.

The aim of this study is to compare US-guided FICB and ESPB for postoperative analgesia management after total hip prosthesis surgery.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mursel Ekinci

Bursa, Turkey (Türkiye)

About this study

Hip arthroplasty surgery is frequently performed on elderly patients in the community and it is associated with long-term postoperative hospital stays and high mortality. Severe postoperative pain may further reduce the limited cardiopulmonary capacity, especially in the elderly population. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced.

Postoperative pain management is a multimodal process that includes intravenous and regional anesthesia methods. Parenteral opioids are generally preferred in the management of acute postoperative pain. However, opioids have undesired adverse events such as nausea, vomiting, itching, sedation, and respiratory depression (opioid-related adverse events). Regional anesthesia techniques are frequently preferred as a part of multimodal analgesia in hip surgeries. Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment. US-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice.

The ultrasound(US) guided erector spinae plane block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. Visualization of sonoanatomy with the US is simple and the spread of local anesthetic solution can be seen easily in the deep fascia of the erector spinae. Visualization of sonoanatomy in the US is easy, and the spread of local anesthetic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. Cadaveric studies have shown that the injection spreads to the ventral and dorsal roots of the spinal nerves. In the literature, it has been reported that ESPB provides effective analgesia after a hip surgery. The fascia iliaca compartment block (FICB) is a safe method used for postoperative analgesia following hip, femoral, and knee surgeries.

The aim of this study is to compare US-guided FICB and ESPB for postoperative analgesia management after total hip prosthesis surgery. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), and adverse effects related to opioids (allergic reaction, nausea, vomiting).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with ASA classification I-III
  • Aged 18-80 years
  • Who will be scheduled for total hip prosthesis surgery under spinal anesthesia

Exclusion criteria

  • Patients who have a history of bleeding diathesis
  • Take anticoagulant therapy
  • History of chronic pain before surgery
  • Known local anesthetics and opioid allergy
  • Pregnancy or lactation
  • Infection at the site of block
  • Patients who do not accept the procedure

Treatment and study plan

Postoperative analgesia management

Drug

Intravenous paracetamol 1 gr and a dose of 0,5 mg/kg-1 tramadol intravenously will be performed on all patients 30 min before the end of the surgery for postoperative analgesia. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. A patient-controlled device prepared with 5 mg/ ml tramadol will be attached to all patients with a protocol including 10 mg bolus without infusion dose, 10 min lockout time, and 4-hour limit. If the VAS score will be ≥ 4, 0,5 mg/kg-1 meperidine IV will be administered.

Primary outcomes

  1. Opioid consumption

    Time frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.

    The tramadol consumption on PCA device will be evaluated

Secondary outcomes

  1. Postoperative pain score

    Time frame: Postoperative 1, 2, 4, 8, 16 and 24 hours

    Postoperative pain assessment will be performed using the Numerical Rating Scale (0 = no pain, 10 = the most severe pain felt)

Sponsors and collaborators

Lead sponsor

Mursel Ekinci

Other Gov

Registry information

Official study title

Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block And Fascia Iliaca Compartment Block for Pain Management Following Total Hip Prosthesis Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 17, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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