Hip Arthropathy
Conditions
Brief summary
This study will assess if preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) with ropivacaine and glucocorticoids provide more effective analgesia than periarticular injection (PAI) with the same mixture in total hip arthroplasty (THA).
Detailed description
To support our hypothesis that preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) provides more effective analgesia than periarticular injection (PAI) in total hip arthroplasty (THA), we will look at the following outcomes: Primary outcome: Daily opioid consumption Secondary outcomes: Pain intensity and physical functioning while in the hospital: using pain inventory modified from Brief Pain Inventory and Length of hospital stays. Since both QLB/LFCNB nerve block and PAI techniques are both routinely used as standard of care anesthesia for THA, the study intervention will be the randomization to assign patients to one of these treatment options and assess their response from post-op patient questionnaires and data collection. When results were entered, the detailed description was updated to reflect the outcome measures used in the study.
Interventions
PROCEDURENerve Block
Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service. 1. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA 2. LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA
PROCEDUREPeriarticular Injection (PAI)
Intraoperatively, the surgeon will perform PAI per standard of care with the medications: 1\. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA
DRUGRopivacaine
60 ml 0.2% ropivacaine
DRUGDex
10 mg DEX/ 80 mg MPA
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective unilateral primary THA * All surgical approaches * American Society of Anesthesiologist (ASA) status I, II and III.
Exclusion criteria
* Patient refusal; * Age less than 18 years * Those with cognitive dysfunction, psychiatric disorder, or non-English speaking patients that cannot consent or communicate clear understanding of the protocol with research team; * Coagulopathy;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Opioid Consumption | Up to 72 hours | Daily opioid consumption will be monitored during the patient's post surgical hospitalization. Data are presented as milligram morphine equivalent (MME). When the results were entered, the time frame was corrected to reflect the final approved protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | Up to 5 days | The patient's post surgical length of stay in the hospital will be compared between treatment groups. Length of stay is presented as average total hours in hospital. |
| Change in Pain Intensity While in Hospital | Up to 2 days | Pain intensity will be assessed using a pain inventory modified from Brief Pain Inventory (BPI). The BPI has a range of 0-10 where: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Outcome measure was updated at the time of results entry. |
| Harris Hip Score | 2 weeks post operation | The Harris Hip Score (HHS) assesses post operative conditions following hip surgery. The HHS uses a 100 point score wherethe scores are interpreted as follows: \< 70 = poor, 70-79 = fair, 80-89 = good and 90-100 = excellent. |
| Brief Pain Inventory: Interference | 2 weeks post operation | The Brief Pain Inventory: Interference (BPI:I) was used in place of the Harris Hip Score (HHS) to assess post operative conditions following hip surgery. The BPI:I uses a 10 point score where the normal range of scores is: 0 no interference - 10 complete interference. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group Will NOT Receive Any Nerve Blocks. Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon.
Periarticular Injection (PAI): Intraoperatively, the surgeon will perform PAI per standard of care with the medications:
1\. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA
Ropivacaine: 60 ml 0.2% ropivacaine
Dex: 10 mg DEX/ 80 mg MPA | 95 |
| Group Will Receive Nerve Block Per Standard of Care Nerve blocks (QLB/LFCNB) to be placed preoperatively with dexamethasone sodium phosphate (DEX) and methylprednisolone acetate (MPA), per standard of care of anesthesia block service.
1. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; and
2. LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Preoperatively, Group 1 patients will receive nerve block per standard of care as stated above. Intraoperatively, Group 1 will NOT receive PAI.
Nerve Block: Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service.
1. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA
2. LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA
Ropivacaine: 60 ml 0.2% ropivacaine | 93 |
| Total | 188 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | immediate postoperative revision | 2 | 2 |
Baseline characteristics
| Characteristic | Group Will NOT Receive Any Nerve Blocks. | Total | Group Will Receive Nerve Block Per Standard of Care |
|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 10.4 | 61.4 years STANDARD_DEVIATION 10.4 | 61.3 years STANDARD_DEVIATION 10.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 6 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 89 Participants | 180 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 24 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) White | 77 Participants | 155 Participants | 78 Participants |
| Region of Enrollment United States | 95 participants | 188 participants | 93 participants |
| Sex: Female, Male Female | 52 Participants | 96 Participants | 44 Participants |
| Sex: Female, Male Male | 43 Participants | 92 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 93 |
| other Total, other adverse events | 0 / 95 | 0 / 93 |
| serious Total, serious adverse events | 0 / 95 | 0 / 93 |
Outcome results
Primary
Daily Opioid Consumption
Daily opioid consumption will be monitored during the patient's post surgical hospitalization. Data are presented as milligram morphine equivalent (MME). When the results were entered, the time frame was corrected to reflect the final approved protocol.
Time frame: Up to 72 hours
Population: Final analysis population (completed from Participant Flow)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Will NOT Receive Any Nerve Blocks. | Daily Opioid Consumption | 12 hours Post Op | 29.3 milligram | Standard Deviation 24 |
| Group Will NOT Receive Any Nerve Blocks. | Daily Opioid Consumption | 24 hours Post Op | 49.6 milligram | Standard Deviation 36.8 |
| Group Will NOT Receive Any Nerve Blocks. | Daily Opioid Consumption | 48 Hours Post Op | 62.1 milligram | Standard Deviation 47.7 |
| Group Will NOT Receive Any Nerve Blocks. | Daily Opioid Consumption | 72 Hours Post Op | 68.6 milligram | Standard Deviation 58.5 |
| Group Will Receive Nerve Block Per Standard of Care | Daily Opioid Consumption | 72 Hours Post Op | 71.4 milligram | Standard Deviation 55.9 |
| Group Will Receive Nerve Block Per Standard of Care | Daily Opioid Consumption | 12 hours Post Op | 30.8 milligram | Standard Deviation 22.7 |
| Group Will Receive Nerve Block Per Standard of Care | Daily Opioid Consumption | 48 Hours Post Op | 67.7 milligram | Standard Deviation 52.4 |
| Group Will Receive Nerve Block Per Standard of Care | Daily Opioid Consumption | 24 hours Post Op | 51.8 milligram | Standard Deviation 37.5 |
Comparison: The primary endpoint was a comparison between groups at 24 hours.p-value: 0.69t-test, 2 sided
Secondary
Brief Pain Inventory: Interference
The Brief Pain Inventory: Interference (BPI:I) was used in place of the Harris Hip Score (HHS) to assess post operative conditions following hip surgery. The BPI:I uses a 10 point score where the normal range of scores is: 0 no interference - 10 complete interference.
Time frame: 2 weeks post operation
Population: Final analysis population (completed from Participant Flow)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Will NOT Receive Any Nerve Blocks. | Brief Pain Inventory: Interference | Pre Operation | 6.2 units on a scale | Standard Deviation 2.5 |
| Group Will NOT Receive Any Nerve Blocks. | Brief Pain Inventory: Interference | 2 Weeks Post Operation | 2.8 units on a scale | Standard Deviation 2.1 |
| Group Will Receive Nerve Block Per Standard of Care | Brief Pain Inventory: Interference | Pre Operation | 6.3 units on a scale | Standard Deviation 2.2 |
| Group Will Receive Nerve Block Per Standard of Care | Brief Pain Inventory: Interference | 2 Weeks Post Operation | 2.8 units on a scale | Standard Deviation 2.1 |
Comparison: Scores were compared at 2 weeks.p-value: 0.85t-test, 2 sided
Secondary
Change in Pain Intensity While in Hospital
Pain intensity will be assessed using a pain inventory modified from Brief Pain Inventory (BPI). The BPI has a range of 0-10 where: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Outcome measure was updated at the time of results entry.
Time frame: Up to 2 days
Population: Final analysis population (completed from Participant Flow)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Will NOT Receive Any Nerve Blocks. | Change in Pain Intensity While in Hospital | Pre Operation | 4.9 units on a scale | Standard Deviation 2.4 |
| Group Will NOT Receive Any Nerve Blocks. | Change in Pain Intensity While in Hospital | Post Operation Day 1 | 4.2 units on a scale | Standard Deviation 2.1 |
| Group Will NOT Receive Any Nerve Blocks. | Change in Pain Intensity While in Hospital | Post Operation Day 2 | 3.9 units on a scale | Standard Deviation 2.3 |
| Group Will Receive Nerve Block Per Standard of Care | Change in Pain Intensity While in Hospital | Pre Operation | 5.0 units on a scale | Standard Deviation 2.1 |
| Group Will Receive Nerve Block Per Standard of Care | Change in Pain Intensity While in Hospital | Post Operation Day 1 | 4.4 units on a scale | Standard Deviation 2 |
| Group Will Receive Nerve Block Per Standard of Care | Change in Pain Intensity While in Hospital | Post Operation Day 2 | 4.0 units on a scale | Standard Deviation 1.9 |
Comparison: Scores were compared at 2 days post operation.p-value: 0.92t-test, 2 sided
Secondary
Harris Hip Score
The Harris Hip Score (HHS) assesses post operative conditions following hip surgery. The HHS uses a 100 point score wherethe scores are interpreted as follows: \< 70 = poor, 70-79 = fair, 80-89 = good and 90-100 = excellent.
Time frame: 2 weeks post operation
Population: This measure was not used but the Brief Pain Inventory: Interference scale was used instead.
Secondary
Length of Stay
The patient's post surgical length of stay in the hospital will be compared between treatment groups. Length of stay is presented as average total hours in hospital.
Time frame: Up to 5 days
Population: Final analysis population (completed from Participant Flow)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Will NOT Receive Any Nerve Blocks. | Length of Stay | 47.2 hours | Standard Deviation 24.8 |
| Group Will Receive Nerve Block Per Standard of Care | Length of Stay | 46.7 hours | Standard Deviation 25.9 |
p-value: 0.91t-test, 2 sided