Postoperative Pain
Conditions
Keywords
Nerve block, Periarticular infiltration, Ropivacaine, Pain
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.
Interventions
DRUGRopivacaine
Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
DRUGEpinephrine
0.5 mg epinephrine
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Compartment Block Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine | 30 |
| Infiltration Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Infiltration | Total | Compartment Block |
|---|---|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 11.2 | 57.6 years STANDARD_DEVIATION 12.4 | 56.2 years STANDARD_DEVIATION 13.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 23 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 37 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Preoperative Pain Score at Rest | 4 units on a scale | 4 units on a scale | 3 units on a scale |
| Preoperative Pain Score with Cough | 8 units on a scale | 8 units on a scale | 4 units on a scale |
| Region of Enrollment United States | 30 Participants | 60 Participants | 30 Participants |
| Sex: Female, Male Female | 18 Participants | 36 Participants | 18 Participants |
| Sex: Female, Male Male | 12 Participants | 24 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Postoperative Pain Score at Resting
The Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
Time frame: Postoperative 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Compartment Block | Postoperative Pain Score at Resting | 1 units on a scale |
| Infiltration | Postoperative Pain Score at Resting | 2 units on a scale |
Comparison: The study was powered to detect a mean difference of 1.5 in pain scores in favor of patients undergoing SFICB procedure assuming a standard deviation of 2.5. With a two sided alpha level of 0.05, a total of 52 patients would be needed to have 80% power using a repeated measures ANOVA F test with 6 observations on each subject. Correlation on the repeat observations was assumed to be 0.5. Assuming a 14% loss to follow-up, 60 patients were enrolled at 1:1 ratio.p-value: 0.05ANOVA
Primary
Postoperative Pain Score With Movement
The Visual Analog Pain Score (VAS) with movement on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
Time frame: Postoperative 48 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Compartment Block | Postoperative Pain Score With Movement | 3 units on a scale |
| Infiltration | Postoperative Pain Score With Movement | 4 units on a scale |
p-value: 0.05ANOVA
Secondary
Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours
Total amounts of postoperative opioid requirements for 48 hours postoperatively
Time frame: Postoperative 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compartment Block | Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours | 101.0 Oral Morphine Equivalent (mg) | Standard Deviation 29.5 |
| Infiltration | Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours | 115.6 Oral Morphine Equivalent (mg) | Standard Deviation 46 |
p-value: 0.149t-test, 2 sided
Secondary
The Time to Ambulation
The time to ambulation during 48 hours postoperative period
Time frame: Postoperative 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Compartment Block | The Time to Ambulation | 21.3 Hours |
| Infiltration | The Time to Ambulation | 22 Hours |
p-value: 0.584Wilcoxon (Mann-Whitney)