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NCT Number: NCT06534697

Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty

This clinical trial aims to assess the analgesic efficacy of ultrasound-guided FIB using different analgesic combinations administered into the iliac fascia compartment. The main question it aims to answer is:

·What is the total morphine (mg) consumption at 24 hours postoperatively for each of the three groups?

The secondary questions are:

* What is the length of stay in hospital for each group? * What is the risk of falling associated with the use of fascia iliaca block? Researchers will compare two analgesic combinations of local anesthestic naropin 0,25% versus dextrose 10% administered by fascia iliaca block for postoperative pain after total hip arthroplasty.

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Key information

About this study

The investigators plan to conduct a single-center, prospective, blinded, randomized controlled study of 150 eligible patients undergoing elective THA via a miniinvasive anterior approach starting June 2024. All patients will receive spinal anesthesia and preoperatively FIB for analgesia. The investigators define randomly three patient groups: Group 1, receiving 40 ml naropin 0,25% in saline, Group 2, receiving 40 ml naropin 0,25% in dextrose 5%, and Group 3, receiving 40 ml dextrose 10%. After the regression of spinal anesthesia, all the patients receive the same multimodal pain therapy according to the visual analog scale (VAS), including Paracetamol IV, NSAID, and morphine, according to the pain protocol in our hospital. The primary endpoint of the study is total morphine (mg) consumption at 24 hours postoperatively, and the secondary goals were length of stay and the risk of fall.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Indication of total primary hip arthroplasty
  • ASA I-III
  • BMI<40 kg/m2

Exclusion criteria

  • Inability or refusal to sign informed consent
  • Known allergies to any of the drugs used in the study
  • Hepatic or renal insufficiency
  • Gastritis or gastroduodenal ulcer
  • Opioid dependency
  • Coagulopathy
  • Pregnancy
  • Scars in the surgery and fascia iliaca block areas
  • Clinical evidence of peripheral neuropathies.

Treatment and study plan

Naropin, 0.2% Injectable Solution in Sodium chloride

Drug

Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in sodium chloride

Other names: Ropivacaine 0.25%-Sodium chloride

Naropin, 0.2% Injectable Solution in dextrose 5%

Drug

Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in dextrose 5%

Other names: Ropivacaine 0.25%-Dextrose 5%

Dextrose 10 % in Water

Drug

Preoperative fascia iliaca block with 40 ml volume of dextrose 10%

Other names: Dextrose 10%

Primary outcomes

  1. The total morphine consumption

    Time frame: 24 hours postoperatively

    The total morphine consumption is measured in mg

Secondary outcomes

  1. The risk of fall

    Time frame: Up to 1 week

    The percent of the number of falls reported to the number of the patients for each arm

  2. Length of stay in hospital

    Time frame: Up to 1 week

    The duration between admision and discharge of the hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Denisa Anastase, MD, PhD

CONTACT

[email protected]

0040721255339

Simona Florescu Cionac, MD, PhD

CONTACT

[email protected]

0040722381861

Sponsors and collaborators

Lead sponsor

Foisor Orthopedics Clinical Hospital

Other

Registry information

Official study title

Analgesic Efficacy of Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty: a Randomised Controlled Study

Acronym: FIB-PAIN

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 2, 2024
Registry last updated
Aug 2, 2024

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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