Trial Outcomes & Findings for Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty (NCT NCT03977454)
NCT ID: NCT03977454
Last Updated: 2022-09-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
192 participants
Primary outcome timeframe
Up to 72 hours
Results posted on
2022-09-23
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
95
|
|
Overall Study
COMPLETED
|
95
|
93
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
immediate postoperative revision
|
2
|
2
|
Baseline Characteristics
Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty
Baseline characteristics by cohort
| Measure |
Group Will NOT Receive Any Nerve Blocks.
n=95 Participants
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
|
Group Will Receive Nerve Block Per Standard of Care
n=93 Participants
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
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
95 participants
n=5 Participants
|
93 participants
n=7 Participants
|
188 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 72 hoursPopulation: Final analysis population (completed from Participant Flow)
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.
Outcome measures
| Measure |
Group Will NOT Receive Any Nerve Blocks.
n=95 Participants
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
|
Group Will Receive Nerve Block Per Standard of Care
n=93 Participants
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
|
|---|---|---|
|
Daily Opioid Consumption
72 Hours Post Op
|
68.6 milligram
Standard Deviation 58.5
|
71.4 milligram
Standard Deviation 55.9
|
|
Daily Opioid Consumption
12 hours Post Op
|
29.3 milligram
Standard Deviation 24.0
|
30.8 milligram
Standard Deviation 22.7
|
|
Daily Opioid Consumption
24 hours Post Op
|
49.6 milligram
Standard Deviation 36.8
|
51.8 milligram
Standard Deviation 37.5
|
|
Daily Opioid Consumption
48 Hours Post Op
|
62.1 milligram
Standard Deviation 47.7
|
67.7 milligram
Standard Deviation 52.4
|
SECONDARY outcome
Timeframe: Up to 2 daysPopulation: Final analysis population (completed from Participant Flow)
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.
Outcome measures
| Measure |
Group Will NOT Receive Any Nerve Blocks.
n=95 Participants
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
|
Group Will Receive Nerve Block Per Standard of Care
n=93 Participants
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
|
|---|---|---|
|
Change in Pain Intensity While in Hospital
Pre Operation
|
4.9 units on a scale
Standard Deviation 2.4
|
5.0 units on a scale
Standard Deviation 2.1
|
|
Change in Pain Intensity While in Hospital
Post Operation Day 1
|
4.2 units on a scale
Standard Deviation 2.1
|
4.4 units on a scale
Standard Deviation 2.0
|
|
Change in Pain Intensity While in Hospital
Post Operation Day 2
|
3.9 units on a scale
Standard Deviation 2.3
|
4.0 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Up to 5 daysPopulation: Final analysis population (completed from Participant Flow)
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.
Outcome measures
| Measure |
Group Will NOT Receive Any Nerve Blocks.
n=95 Participants
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
|
Group Will Receive Nerve Block Per Standard of Care
n=93 Participants
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
|
|---|---|---|
|
Length of Stay
|
47.2 hours
Standard Deviation 24.8
|
46.7 hours
Standard Deviation 25.9
|
SECONDARY outcome
Timeframe: 2 weeks post operationPopulation: This measure was not used but the Brief Pain Inventory: Interference scale was used instead.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeks post operationPopulation: Final analysis population (completed from Participant Flow)
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.
Outcome measures
| Measure |
Group Will NOT Receive Any Nerve Blocks.
n=95 Participants
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
|
Group Will Receive Nerve Block Per Standard of Care
n=93 Participants
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
|
|---|---|---|
|
Brief Pain Inventory: Interference
Pre Operation
|
6.2 units on a scale
Standard Deviation 2.5
|
6.3 units on a scale
Standard Deviation 2.2
|
|
Brief Pain Inventory: Interference
2 Weeks Post Operation
|
2.8 units on a scale
Standard Deviation 2.1
|
2.8 units on a scale
Standard Deviation 2.1
|
Adverse Events
Group Will NOT Receive Any Nerve Blocks.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group Will Receive Nerve Block Per Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jinlei Li, MD, PhD
Yale School of Medicine: Anesthesiology
Phone: (203) 785-2802
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place