Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration

Not Applicable

Completed

Conditions: Postoperative Pain

Interventions: Drug: Ropivacaine
Drug: Epinephrine

Registration Number: NCT02658240

Lead Sponsor: University of Texas Southwestern Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compartment Block	Ropivacaine	Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery
Compartment Block	Epinephrine	Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery
Infiltration	Ropivacaine	Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision
Infiltration	Epinephrine	Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Score With Movement	Postoperative 48 hours	The Visual Analog Pain Score (VAS) with movement on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
Postoperative Pain Score at Resting	Postoperative 48 hours	The Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours	Postoperative 48 hours	Total amounts of postoperative opioid requirements for 48 hours postoperatively
The Time to Ambulation	Postoperative 48 hours	The time to ambulation during 48 hours postoperative period

Trial Locations

Locations (1): UTSW Parkland Health Hospital System
🇺🇸
Dallas, Texas, United States
UTSW Parkland Health Hospital System
🇺🇸Dallas, Texas, United States