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Completed

NCT Number: NCT02108847

Ultrasound Guided Fascia Iliaca Block for Pain Control After Elective Hip Replacement Surgery

The purpose of this study is to determine whether ultrasound guided fascia iliaca blocks performed before surgery help to reduce pain after elective total hip replacements.

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Key information

Conditions

Arthroplasty, Replacement, Hip Fascia Iliaca Block Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saskatoon City Hospital

Saskatoon, Saskatchewan, Canada

About this study

Total hip arthroplasty is associated with moderate to severe pain in the acute postoperative period, which can increase the risk of postoperative complications such as thromboembolism, myocardial ischemia/infarction, pneumonia, poor wound healing, insomnia, and delirium.

Sensory innervation of the hip joint comes from a combination of peripheral nerves, including femoral, obturator, sciatic, superior gluteal, and nerve for the quadratus femoris muscle. Superficial innervation of the skin involved in incision for hip arthroplasty comes from the lateral femoral cutaneous nerve (LFCN).

The fascia iliaca block (FIB) was originally described in 1989 using a landmark technique. The ultrasound guided FIB was introduced in recent years, and has been shown to produce a better quality of block than the landmark technique. It appears to consistently block the femoral and LFCN, while being less successful in achieving consistent obturator blockade.

The FIB is effective for analgesia for hip fracture injuries in the emergency department. Thus far, there has been limited exploration into the potential use of this block as a tool for postoperative analgesia after elective hip arthroplasty. The potential benefits of this regional block, as with other regional techniques, include better analgesia, less opioid use and associated side effects, and an improved overall patient satisfaction with postoperative recovery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists' (ASA) score I, II or III
  • Scheduled for elective total hip arthroplasty

Exclusion criteria

  • Contraindication to regional anesthesia (allergy to local anesthetic, coagulopathy, infection or malignancy in the area)
  • Neurologic disorder affecting the ability to sense pain
  • Long term opioid use or chronic pain disorder
  • History of drug or alcohol abuse
  • Patient refusal
  • Pregnancy
  • Revision procedures
  • General anesthetic
  • Psychiatric or mental conditions that may affect assessment of outcomes

Treatment and study plan

.2% Ropivacaine

Drug

Saline

Drug

Fascia iliaca block

Procedure

Ultrasound-guided regional anesthesia block to the groin area.

Primary outcomes

  1. Cumulative opioid consumption

    Time frame: 12 hours after surgery

    Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison

  2. Cumulative opioid consumption

    Time frame: 24 hours after surgery

    Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison

Secondary outcomes

  1. Cumulative opioid consumption

    Time frame: 4, 8, and 48 hours after surgery

    Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison

  2. Verbal pain score (static and dynamic)

    Time frame: PACU, 4, 8, 12, 24, and 48 hours after surgery

    Pain score 0-10 with 10 being worst possible pain

  3. Opioid side effect (nausea/vomiting, pruritus, constipation, urinary retention, sedation)

    Time frame: PACU, 4, 8, 12, 24, and 48 hours after surgery

    Presence of each side effect documented as "yes" or "no". Sedation will be assessed by the Ramsay Sedation Scale.

  4. Overall patient satisfaction

    Time frame: 48 hours after surgery

    Satisfaction rated as: very dissatisfied, dissatisfied, neutral, satisfied, or very satisfied

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Saskatoon Health Region

Registry information

Official study title

Ultrasound Guided Fascia Iliaca Block for Postoperative Analgesia After Elective Total Hip Arthroplasty

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2014
Registry last updated
Nov 15, 2016

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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