Quadratus Lumborum Block for Total Hip Arthroplasty
Study Details
Study Description
Brief Summary
The quadratus lumborum (QL) block is a fascial plane block primarily used to provide pain relief in abdominal surgeries. Most literature on the QL block focuses on pain control after lower abdominal, urologic (urinary tract system) or gynecologic (reproductive system) surgeries, however, its pain relief coverage has been described as wide as T7-L3 dermatomes (pain relief that extends from the lower chest to the knee) and as such, may prove applicable in lower extremity surgeries such as the total hip arthroplasty (THA, a surgical procedure performed to restore function of the hip joint). Further investigation regarding the efficacy of QL blocks in patients undergoing primary THA under spinal anesthesia (a procedure that numbs from the waist down) would be of value, particularly as there is a push towards opioid-sparing analgesia (pain relief that minimizes the use of opiates) and reducing hospital length of stay, something that can be minimized with better patient pain control after surgery. The investigators aim to evaluate the efficacy of ultrasound guided QL nerve blocks as a method of analgesia (pain relief) for patients undergoing primary THA.
Patients will be randomized to receive a QL nerve block with either saline or ropivacaine (a local anesthetic) prior to their surgical procedure. The QL nerve block procedure will take between 3 and 10 minutes of the patient's time. During this procedure the patient will be made comfortable either with local anesthetic medication or IV anti-anxiety medications. During the QL nerve block procedure patients will be asked to receive an injection that is placed on the side of their abdomen, between layers of their flank muscles. The injection is placed using the guidance of an ultrasound machine.
Postoperative outcomes assessed will include: pain score, amount of opioid pain medications taken, distance of first ambulation (walking without assistance), length of hospital stay, and patient satisfaction. Outcomes will be assessed at 3hrs, 12hrs, 24hrs, and 48hrs after the surgical procedure ends and will be assessed by a combination of medical record review and by survey. Patients will be surveyed by phone call or in-person visit to the patient's room. Each assessment encounter should take between 1 and 5 minutes.
Participants will be involved in the study through the 48 hour follow-up period and total time required from patients will range from 7 minutes to 30 minutes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
Patients undergoing elective primary THA for osteoarthritis by a single surgeon will be selected for this study. Exclusion criteria will include: patient age < 18, documented allergy to local anesthetic, presence of peripheral neuropathy, patients with current long term opioid use defined as receiving an opioid on most days in a 90 day period, and patients with a contraindication to spinal and regional anesthesia such as coagulopathy or infection at the site of the regional technique. Additionally, patients who receive general anesthesia during the surgery, either as part of the planned anesthetic (at the discretion of the patient's assigned anesthesiologist) or as a rescue for failed spinal will be excluded from the study. More specifically, if a patient is found to be moving their lower extremities or showing signs of sensation in the lower extremities 15 minutes after the spinal procedure is performed, this would be considered a failed spinal. In the case of a failed spinal, the anesthesiologist would make a determination about the safety of proceeding with general anesthesia versus aborting the surgery. If safe and consented for, or if emergent general anesthesia is required, then the patient would be induced (given medications to begin) general anesthesia in a manner appropriate for the individual patient, taking into account their body habitus and medical history. Any patient who undergoes general anesthesia, including those for whom it is used as a rescue anesthetic as described, will be excluded from the study.
Patients will all receive the same preoperative orally administered medication of 1000mg acetaminophen. Prior to their surgical procedure on the day of surgery patients will receive a unilateral ultrasound guided posterior quadratus lumborum nerve block either with 30 mL of normal saline or 30 mL of 0.25% ropivacaine on the side of surgery, depending on random assignment to control or intervention group.
Patient randomization will be achieved with a random number generator (0 for placebo and 1 for intervention) organized in a list and inserted into consecutive numbered envelopes corresponding to up to the total N of the study. Subjects recruited into the study will be assigned to receive the intervention based on the randomization list. A separate study design member will draw up the assigned medication (either saline or 0.25% ropivacaine depending on randomization) and label the syringe with the patient label. This person will then be excluded from further care or evaluation of the patient. The regional anesthesia team will then perform the block before or after spinal placement. Intraoperatively, the patient will receive sedation at the preference of the anesthesiology team. Post-operative evaluation and data collection will then be performed by the regional anesthesia team. Thus, the patient, the surgeon, the regional anesthesia team, and the intraoperative anesthesiologist will be blinded to the medication the patient actually received.
Post-operative analgesia will be achieved with scheduled acetaminophen 1000mg every 8 hours and sliding scale oxycodone 5/10/15 mg every 4 hours as needed with 0.2 mg hydromorphone every 2 hours as needed for severe breakthrough pain according to patient reported pain scores. Post-operative outcomes evaluation will be performed by the regional anesthesia team. Numeric rating scale pain scores from 0 (no pain) to 10 (worst pain imaginable) at 3 hours, 12 hours, 24 hours, and 48 hours post-operatively will be recorded for each patient. Total morphine-equivalent consumption of opiate medications will be recorded retrospectively during the 0-24 hours and 24-48 hours post operatively. Additional outcomes that will be measured will include ambulation distance on first session with physical therapy, length of hospital stay, and patient satisfaction scores on day of discharge as measured by a 5-point scale with 1 = terrible, 2 = poor, 3 = satisfactory, 4 = good, and 5 = excellent. Medical records will also be reviewed for data collection.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intervention Group Quadratus lumborum nerve block with 0.25% ropivacaine |
Drug: QL block with active comparator
QL block with 0.25% ropivacaine
|
| Placebo Comparator: Control Group Quadratus lumborum nerve block with saline |
Drug: QL block with placebo comparator
QL block with saline
|
Outcome Measures
Primary Outcome Measures
- Pain Score [2 days]
Pain scores will be assessed at 3hrs, 12hrs, 24hrs, and 48hrs postop using the visual analog score (Scale 0-10). Zero for no pain and ten being the worst pain experienced.
Secondary Outcome Measures
- Opioid usage [2 days]
Total morphine-equivalent will be calculated each day at 0-24hrs and 24-48hrs postop.
- Time to first stand [up to 1 week after your surgery (on average, the day of your surgery or 1-2 days after)]
The period between the end of surgery and the patient's first successful attempt at standing, with or without the assistance of devices (i.e. walker, cane) or staff assistance.
- Time to first ambulation [up to 1 week after your surgery (on average, the day of your surgery or 1-2 days after)]
Time to first ambulation of 50 feet or more, with or without the help of assist devices (i.e. walker, cane) or staff assistance.
- Ambulation distance [First physical therapy session usually occurs on the day of your surgery or the day after]
This data point will be measured in feet and will be determined by the distance ambulated during the patient's first ambulation attempt after surgery, regardless of the length of ambulation (This distance will be counted regardless of whether the patient reaches the 50 feet requirement to be counted as the "time to first ambulation).
- Length of hospital stay [Postop day 0 until discharge from the hospital, an average of 2 days]
Number of days in the hospital from postoperative day 0 to discharge
- Patient satisfaction [Day of discharge from the hospital, on average 2 days after your surgery]
Patient satisfaction score will be assessed on day of discharge as measured by a 5-point scale with 1 = terrible, 2 = poor, 3 = satisfactory, 4 = good, and 5 = excellent.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adult patients undergoing elective primary total hip arthroplasty for osteoarthritis by a single surgeon.
Exclusion Criteria:
-
patients age < 18,
-
documented allergy to local anesthetic,
-
presence of peripheral neuropathy,
-
patients with current long term opioid use defined as receiving an opioid on most days in a 90 day period, and
-
patients with a contraindication to spinal and regional anesthesia such as coagulopathy or infection at the site of the regional technique.
-
Additionally, patients who receive general anesthesia during the surgery, either as part of the planned anesthetic (at the discretion of the patient's assigned anesthesiologist) or as a rescue anesthetic after a failed spinal, will be excluded from the study. More specifically, if a patient is found to be moving their lower extremities or showing signs of sensation in the lower extremities 15 minutes after the spinal procedure is performed, this would be considered a failed spinal. In the case of a failed spinal, general anesthesia would be required to continue with surgery. After detection of a failed spinal, the anesthesiologist would make a determination about the safety of proceeding with general anesthesia versus aborting the surgery. If safe and consented for, or if emergent general anesthesia is required, the patient would be induced (given medications to begin) general anesthesia in a manner appropriate for the individual patient, taking into account their body habitus and medical history. Any patient who undergoes general anesthesia, including those for whom it is used as a rescue anesthetic as described, will be excluded from the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA Medical Center, Santa Monica | Santa Monica | California | United States | 90404 |
Sponsors and Collaborators
- University of California, Los Angeles
Investigators
- Principal Investigator: Eva Boyd, MD, University of California, Los Angeles
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-001850