Clinical trial NCT02658240: Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration
Official title: Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration for Pain Management After Total Hip Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Nerve block
Periarticular infiltration
Ropivacaine
Pain
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, controlled, observer-blinded study clinical trial was designed to evaluate ultrasound-guided fascia iliaca compartment block with ropivacaine and periarticular infiltration with ropivacaine for postoperative pain management after total hip arthroplasty.

Detailed description: Despite substantial advances in our understanding of the pathophysiology of pain and availability of newer analgesic techniques, postoperative pain is not always effectively treated. Optimal pain management technique balances pain relief with concerns about safety and adverse effects associated with analgesic techniques. Currently, postoperative pain is commonly treated with systemic opioids, which are associated with numerous adverse effects including nausea and vomiting, dizziness, drowsiness, pruritus, urinary retention, and respiratory depression. Use of regional and local anesthesia has been shown to reduce opioid requirements and opioid-related side effects.

Patients undergoing total hip arthroplasty (THA) (n=60) at Parkland and UT Southwestern Medical Center Hospitals will be randomized into one of two groups to receive either ultrasound-guided fascia iliaca compartment block (FICB) with ropivacaine 300 mg and 0.5 mg epinephrine (Group 1) or periarticular infiltration ropivacaine 300 mg and 0.5 mg epinephrine total (Group 2) for postoperative pain management. The remaining aspect of perioperative care, including the anesthetic technique (i.e., spinal anesthetic), pre- and postoperative care will be standardized and will be similar for all patients. The duration of the involvement in the study will be until 48 hours postoperatively.

Patients in Group 1 will receive ultrasound-guided FICB after surgery. Patients in Group 2 will receive ropivacaine via periarticular infiltration prior to closing the incision.

The postoperative analgesia will be documented using the visual analog score (0=no pain, 10=worst pain). In addition, total opioid dose over the 48-h study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue antiemetics will be given to any patient who complains of nausea and/or vomiting. All variables will be assessed at 2, 6, 12, 24, and 48 hours, postoperatively by an investigator blinded to group allocation.

Eligibility criteria: Inclusion Criteria:

* Female ASA physical status 1-3 scheduled for total hip arthroplasty
* Age 18-80 years old
* Able to participate personally or by legal representative in informed consent in English or Spanish

Exclusion Criteria:

* History of relevant drug allergy
* Age less than 18 or greater than 80 years
* Chronic opioid use or drug abuse
* Significant psychiatric disturbance
* Inability to understand the study protocol
* Refusal to provide written consent

Primary outcomes:
measure: Postoperative Pain Score at Resting
timeFrame: Postoperative 48 hours
measure: Postoperative Pain Score With Movement
timeFrame: Postoperative 48 hours
Secondary outcomes:
measure: Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours
timeFrame: Postoperative 48 hours
measure: The Time to Ambulation
timeFrame: Postoperative 48 hours
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UTSW Parkland Health Hospital System
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Irina Gasanova, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gasanova I, Alexander JC, Estrera K, Wells J, Sunna M, Minhajuddin A, Joshi GP. Ultrasound-guided suprainguinal fascia iliaca compartment block versus periarticular infiltration for pain management after total hip arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2019 Feb;44(2):206-211. doi: 10.1136/rapm-2018-000016.