Phase 4 N=60 Randomized Double-blind Treatment

Volume Versus Concentration: Clinical Effectiveness of Single Shot Quadrates Lumborum Block Using Either a High Volume/Low Concentration or Low Volume/High Concentration Injectate for Total Hip Arthroplasty.

Acute Pain

Bottom Line

View on ClinicalTrials.gov: NCT04259645 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: Consumption of Opioids During the First 24 Hours After Surgery. — 46.2; 35.0 mg morphine equivalents per 24 hours

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Drug: Bupivacaine 0.375% 20 mL (Drug); Drug: Bupivacaine 0.375% diluted to 0.1875% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Anna Uskova
Primary completion: Jan 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Consumption of Opioids During the First 24 Hours After Surgery.	46.2; 35.0	—
PRIMARY Pain Measurement Through VAS (Visual Analogue Score) at Rest	4.78; 5.50	—
PRIMARY Pain Measurement Through VAS (Visual Analogue Score) at Rest	4.78; 5.50	—
PRIMARY Pain Measurement Through VAS (Visual Analogue Score) at Rest	4.78; 5.50	—
PRIMARY Pain Measurement Through VAS (Visual Analogue Score) at Rest	4.78; 5.50	—
SECONDARY Time to 100ft Ambulation After Surgery	1534; 1178	—
SECONDARY Time to Consumption of the First Opioid After Surgery.	120; 165	—
SECONDARY Time to Hospital Discharge	1865; 1560	—

Summary

There is Controversy about what is more critical volume or concentration to achieve an optimum analgesic treatment with quadratus lumborum block. From the experiences of the authors, the regular dose of 20 ml of Bupivacaine at 0.375% concentration could not be enough in some cases to produce an optimum analgesic treatment, especially in hip arthroplasties. What is proposed in this study is to evaluate whether the volume injected in the quadratus lumborum block is more important than the concentration of the local anesthetic in terms of control of pain during the next 24 hours after surgery and opioid consumption.

Eligibility Criteria

Inclusion Criteria

Patients 18-80 years old Patients undergoing total hip arthroplasty BMI 19-45, >50 kg Male and Female All races American Society of Anesthesiologists physical status classification I, II, III Spinal Anesthesia Provided

Exclusion Criteria

Pregnancy Non english speaking or inability to participate in the study Patients with coagulopathy or With INR >1.5 the day of the surgery. pharmacologic coagulopathy: patients on xarelto, plavix, or any kind of "Blood Thinners" Chronic steroid use: patients with consumption of steroid for more than 3 months.

Chronic pain: pain for more than 3 months Chronic opiate use : consumption of opioids for more than 3 months.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04259645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.