Anesthesia, Conduction, Osteoarthritis, Hip
Conditions
Keywords
Lumbar Plexus block, total hip arthroplasty, Arthroplasty, direct anterior approach, Pain
Brief summary
This study aims to determine spinal resolution and pain levels after the placement of a lumbar plexus block (LPB) and spinal for total hip replacement procedure. This is a pilot study that looks to collect information in order to design a larger, more significant study comparing Quadratus Lumborum blocks (QLB) and Lumbar Plexus blocks.
Detailed description
The Quadratus Lumborum block (QLB) is a newer regional analgesic technique that may be as effective as Lumbar Plexus blocks (LPB) at providing pain control following direct anterior approach (DAA) hip arthroplasty. The purpose of this study is to collect pilot data to help the design of a future randomized study, comparing a QLB to a LPB for DAA procedures. The investigators will assess for spinal resolution below the level of L5/S1 by assessing the presence of pin prick sensation at these levels. This will help determine if pain scores collected at 6hrs reflect analgesia provided by the preoperative LPB alone or if the data is confounded by the presence of spinal anesthesia. This data will help us determine if 6hrs is a feasible primary endpoint to assess pain scores. Additionally, assuming that spinal regression is complete by 6hrs, the VAS pain scores obtained will then be used to perform a power analysis to determine the necessary study size when comparing QLB to LPB for DAA hip arthroplasty.
Interventions
None listed
Sponsors
Wake Forest University Health Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients that have elective total hip arthroplasty with DAA at Davie Medical Center.
Exclusion criteria
* Patients will be excluded if they do not receive a lumbar plexus block and spinal anesthesia. * and/or if they have peripheral neuropathy affecting their feet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Score With Activity | 6 Hours post block placement | Pain scores will be measured on a verbal pain score when participant sits up in bed. Totals Score range 0-10. Lower scores denote better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Scores at Rest | 6 Hours post block placement | Pain scores will be measured, when the patient is laying still in bed, on a verbal pain scale. Totals Score range 0-10. Lower scores denote better outcomes. |
| Number of Participants Reporting Pin Prick Sensation | 6 Hours post block placement | Assessment for spinal resolution below the level of L5/S1 by assessing the presence of pin prick sensation at these levels. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lumbar Plexus Block Group This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Lumbar Plexus Block Group | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 7 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Patient Pain Score With Activity
Pain scores will be measured on a verbal pain score when participant sits up in bed. Totals Score range 0-10. Lower scores denote better outcomes.
Time frame: 6 Hours post block placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumbar Plexus Block Group | Patient Pain Score With Activity | 1.4 units on a scale | Standard Deviation 1.5 |
Secondary
Number of Participants Reporting Pin Prick Sensation
Assessment for spinal resolution below the level of L5/S1 by assessing the presence of pin prick sensation at these levels.
Time frame: 6 Hours post block placement
Population: Number of patients who had pin prick sensation at the level of L5/S1 6 hours after nerve block and spinal placement.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lumbar Plexus Block Group | Number of Participants Reporting Pin Prick Sensation | 9 Participants |
Secondary
Patient Pain Scores at Rest
Pain scores will be measured, when the patient is laying still in bed, on a verbal pain scale. Totals Score range 0-10. Lower scores denote better outcomes.
Time frame: 6 Hours post block placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumbar Plexus Block Group | Patient Pain Scores at Rest | 1 units on a scale | Standard Deviation 1.1 |