Total Hip Arthroplasty
Conditions
Keywords
Quadratus Lumborum Block
Brief summary
Peripheral nerve blocks for joint and extremity surgeries have long been proven to provide effective post-operative analgesia. Of these surgeries, total hip arthroplasty (THA) remains one of the most common orthopedic procedures in the United States with approximately 300,000 operations performed annually. At our institution, post-operative analgesia in these patients is primarily provided through parenteral and oral opioid medications. Quadratus lumborum blocks (QLB) have been described and implemented for various surgical procedures including caesarean and laparoscopic ovarian surgery. Recently, there has been increasing interest in the efficacy of quadratus lumborum blocks for THA. Currently, case reports have established a precedent regarding the efficacy of the QLB for THA in providing superior analgesia and decreasing visual analog pain scores (VAS), but randomized trials are still lacking. The goal of this study is to compare pain scores (VAS), opioid consumption, physical therapy scores, and patient and surgeon satisfaction in patients that receive QLB versus no peripheral nerve blockade in patients undergoing THA. The results of this study have the potential to change standard of care for patients undergoing THA.
Detailed description
Currently, regional anesthesia techniques for total hip arthroplasty are limited. Fascia iliac blocks have been employed to provide analgesia for hip surgeries with blockade of the femoral, lateral femoral cutaneous, and obturator nerves via injection of local anesthetic in the iliacus fascia. In addition, lumbar plexus blocks have also been employed for post-operative analgesia, but the complexity of the block is high, and complications including epidural anesthesia are not infrequent. The quadratus lumborum block is an abdominal truncal block in which local anesthetic is deposited into the thoracolumbar fascia or the quadratus lumborum muscle itself with the goal of providing analgesia to the ipsilateral T6 - L1 sensory dermatomes. It has already been demonstrated to provide effective post-operative analgesia for certain abdominal and pelvic surgeries, but its use in total hip arthroplasty is limited to case reports. The block is accomplished by identifying the quadratus lumborum muscle, which originates from iliac crest and iliolumbar ligament, and inserted on transverse processes of upper four lumbar vertebrae and posterior border of the 12th rib. Local anesthetic is then deposited at the anterior, posterior or middle thoracolumbar fascia, or intramuscularly, depending on the technique used. Cadaveric studies8 have demonstrated dye spread to the lumbar nerve roots and nerves within the transversus abdominis plane (TAP). Carney et al9 described a posterior TAP block, now known to be synonymous with QLB, that demonstrated contrast spread to the thoracic paravertebral space from T5-L1. Case reports have described analgesia in the corresponding sensory dermatomes after QLB4, and have demonstrated efficacy in patient undergoing THA. The QLB block has potential to cover lateral femoral cutaneous nerve, femoral nerve, obturator nerve and portions of lumbar plexus. This study has been designed to investigate the efficacy of the quadratus lumborum block as a primary method of providing post-operative analgesia in patients undergoing THA. Previous trials have demonstrated the effectiveness of the block for abdominal and pelvic surgeries, and case reports have shown its applicability in hip arthroplasty. In this randomized controlled study we aim to compare QLB (intervention) with control (no intervention) group in patients undergoing THA with regard to the VAS pain scores (at PACU arrival & discharge12, 24 & 36 hours), duration of analgesia, time to first opioid medication, physical therapy evaluations, time to discharge, and surgeon and patient satisfaction scores.
Interventions
Under ultrasound guidance, the needle will be advanced to the posterior border of the quadratus lumborum muscle. After negative aspiration, a bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots, ensuring proper placement of needle tip and appropriate spread of local anesthetic.
DRUGStandard of Care
This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
In this randomized controlled study we aim to compare QLB (intervention) with control (no intervention) group in patients undergoing THA with regard to the VAS pain scores (at PACU arrival & dischage,12, 24 & 36 hours), duration of analgesia, time to first opioid medication, physical therapy evaluations, time to discharge, and surgeon and patient satisfaction scores.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing total hip arthroplasty 2. Adults 18 years of age and older 3. Patients with an American Society of Anesthesiology (ASA) physical status classification of I, II or III
Exclusion criteria
1. Patients with ASA physical status classification other than I, II, or III 2. Patients with allergies/intolerances to local anesthetic 3. Patients with pre-existing neurologic or anatomic deficits in the lower extremity on the side of the surgical site 4. Patients with coexisting coagulopathy 5. Patients that are pharmacologically anticoagulated will be excluded if placement of peripheral nerve block would be contraindicated according to ASRA (American Society for Regional Anesthesia) guidelines or if spinal anesthesia would be contraindicated according to guidelines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores Using Visual Analog Scale (VAS) Scores | Assessed between immediately postoperatively to 12 hours postoperatively | The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older: Rating - Pain Level 0 - No Pain 1-3 - Mild Pain (nagging, annoying, interfering little with \*ADLs) 4-6 - Moderate Pain (interferes significantly with ADLs) 7-10 - Severe Pain (disabling; unable to perform ADLs) \*ADL=Activities of Daily Living |
| Opioid Consumption (Oral Morphine Equivalents) | from 24 hours to 48 hours postoperatively | Total oral morphine equivalent consumption calculated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 24 hours | Patient Satisfaction Score: Determined by patient interview conducted at the 24 hour Time Frame. The interview follows a script requesting current pain level based on a scale of 1-10: 1 = very not satisfied 10 = very satisfied Patient satisfaction is subjective. |
| Hours to Hospital Discharge | Maximum 96 Hours | From time of the surgical procedure to the time of hospital discharge (measured in hours) up to 3 hours. |
| Distance Ambulated | 48 hours | Physical therapist documentation of ambulation distance measured in feet |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Quadratus Lumborum Block (QLB) * Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia. | 36 |
| Standard of Care * Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication. | 35 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Physician Decision | 3 | 3 |
Baseline characteristics
| Characteristic | Quadratus Lumborum Block (QLB) | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 58.61 years STANDARD_DEVIATION 2.74 | 58.305 years STANDARD_DEVIATION 2.4 | 58.00 years STANDARD_DEVIATION 2.06 |
| 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 | 17 Participants | 34 Participants | 17 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 37 Participants | 18 Participants |
| Region of Enrollment United States | 36 participants | 71 participants | 35 participants |
| Sex: Female, Male Female | 20 Participants | 35 Participants | 15 Participants |
| Sex: Female, Male Male | 16 Participants | 36 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 36 |
| other Total, other adverse events | 0 / 35 | 0 / 36 |
| serious Total, serious adverse events | 0 / 35 | 0 / 36 |
Outcome results
Primary
Opioid Consumption (Oral Morphine Equivalents)
Total oral morphine equivalent consumption calculated
Time frame: immediately postoperatively to 24 hours postoperatively
Population: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quadratus Lumborum Block (QLB) | Opioid Consumption (Oral Morphine Equivalents) | 30.05 mg of morphine equivalents | Standard Error 3.8 |
| Standard of Care | Opioid Consumption (Oral Morphine Equivalents) | 47.14 mg of morphine equivalents | Standard Error 4.72 |
Primary
Opioid Consumption (Oral Morphine Equivalents)
Total oral morphine equivalent consumption calculated
Time frame: immediately postoperatively to 48 hours postoperatively
Population: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quadratus Lumborum Block (QLB) | Opioid Consumption (Oral Morphine Equivalents) | 54.63 mg of morphine equivalents | Standard Error 8.25 |
| Standard of Care | Opioid Consumption (Oral Morphine Equivalents) | 90.76 mg of morphine equivalents | Standard Error 10.65 |
Primary
Opioid Consumption (Oral Morphine Equivalents)
Total oral morphine equivalent consumption calculated
Time frame: from 24 hours to 48 hours postoperatively
Population: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quadratus Lumborum Block (QLB) | Opioid Consumption (Oral Morphine Equivalents) | 24.26 mg of morphine equivalents | Standard Error 4.48 |
| Standard of Care | Opioid Consumption (Oral Morphine Equivalents) | 40.52 mg of morphine equivalents | Standard Error 6.31 |
Primary
Pain Scores Using Visual Analog Scale (VAS) Scores
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older: Rating - Pain Level 0 - No Pain 1-3 - Mild Pain (nagging, annoying, interfering little with \*ADLs) 4-6 - Moderate Pain (interferes significantly with ADLs) 7-10 - Severe Pain (disabling; unable to perform ADLs) \*ADL=Activities of Daily Living
Time frame: Immediately postoperatively to 12 hours postoperatively
Population: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quadratus Lumborum Block (QLB) | Pain Scores Using Visual Analog Scale (VAS) Scores | 2.34 score on a scale | Standard Error 0.46 |
| Standard of Care | Pain Scores Using Visual Analog Scale (VAS) Scores | 3.33 score on a scale | Standard Error 0.56 |
Primary
Pain Scores Using Visual Analog Scale (VAS) Scores
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older: Rating - Pain Level 0 - No Pain 1-3 - Mild Pain (nagging, annoying, interfering little with \*ADLs) 4-6 - Moderate Pain (interferes significantly with ADLs) 7-10 - Severe Pain (disabling; unable to perform ADLs) \*ADL=Activities of Daily Living
Time frame: Assessed between immediately postoperatively to 12 hours postoperatively
Population: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quadratus Lumborum Block (QLB) | Pain Scores Using Visual Analog Scale (VAS) Scores | 2.34 units on a scale | Standard Error 0.46 |
| Standard of Care | Pain Scores Using Visual Analog Scale (VAS) Scores | 3.33 units on a scale | Standard Error 0.56 |
Primary
Pain Scores Using Visual Analog Scale (VAS) Scores
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older: Rating - Pain Level 0 - No Pain 1-3 - Mild Pain (nagging, annoying, interfering little with \*ADLs) 4-6 - Moderate Pain (interferes significantly with ADLs) 7-10 - Severe Pain (disabling; unable to perform ADLs) \*ADL=Activities of Daily Living
Time frame: Assessed between immediately postoperatively to 24 hours postoperatively
Population: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quadratus Lumborum Block (QLB) | Pain Scores Using Visual Analog Scale (VAS) Scores | 2.31 units on a scale | Standard Error 0.37 |
| Standard of Care | Pain Scores Using Visual Analog Scale (VAS) Scores | 4.06 units on a scale | Standard Error 0.42 |
Primary
Pain Scores Using Visual Analog Scale (VAS) Scores
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older: Rating - Pain Level 0 - No Pain 1-3 - Mild Pain (nagging, annoying, interfering little with \*ADLs) 4-6 - Moderate Pain (interferes significantly with ADLs) 7-10 - Severe Pain (disabling; unable to perform ADLs) \*ADL=Activities of Daily Living
Time frame: Assessed between immediately postoperatively to 48 hours postoperatively
Population: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quadratus Lumborum Block (QLB) | Pain Scores Using Visual Analog Scale (VAS) Scores | 3.33 units on a scale | Standard Error 0.43 |
| Standard of Care | Pain Scores Using Visual Analog Scale (VAS) Scores | 4.11 units on a scale | Standard Error 0.64 |
Secondary
Distance Ambulated
Physical therapist documentation of ambulation distance measured in feet
Time frame: 48 hours
Population: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quadratus Lumborum Block (QLB) | Distance Ambulated | 127.75 feet | Standard Error 17.33 |
| Standard of Care | Distance Ambulated | 106.69 feet | Standard Error 23.37 |
Secondary
Distance Ambulated
Physical therapist documentation of ambulation distance measured in feet
Time frame: 24 hours
Population: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quadratus Lumborum Block (QLB) | Distance Ambulated | 114.51 feet | Standard Error 10.39 |
| Standard of Care | Distance Ambulated | 100.85 feet | Standard Error 10.6 |
Secondary
Hours to Hospital Discharge
From time of the surgical procedure to the time of hospital discharge (measured in hours) up to 3 hours.
Time frame: Maximum 96 Hours
Population: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quadratus Lumborum Block (QLB) | Hours to Hospital Discharge | 53.17 hours | Standard Error 4.99 |
| Standard of Care | Hours to Hospital Discharge | 55.97 hours | Standard Error 3.78 |
Secondary
Patient Satisfaction
Patient Satisfaction Score: Determined by patient interview conducted at the 24 hour Time Frame. The interview follows a script requesting current pain level based on a scale of 1-10: 1 = very not satisfied 10 = very satisfied Patient satisfaction is subjective.
Time frame: 24 hours
Population: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quadratus Lumborum Block (QLB) | Patient Satisfaction | 9.14 score on a scale | Standard Error 0.28 |
| Standard of Care | Patient Satisfaction | 7.46 score on a scale | Standard Error 0.41 |