Drug: Bupivacaine 0.375% 20 mL
Drug20 mL 0.375% Bupivacaine
Other names: Low Volume
NCT Number: NCT04259645
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.
Looking for future studies?
Notify Me18 year–90 year
All sexes
Interventional
Phase 4
UPMC shadyside hospital, Pittsburgh, Pennsylvania, United States
The Quadratus Lumborum Block (QLB) was originally described by Blanco in 2007 as a posterior variation of the Transversus Abdominis Plane block. It is now, however, recognized as a unique, alternative, and separate interfascial plane block. The QLB has been studied and compared with other types of blocks and it may offer several advantages such as simplicity, safety, and avoidance of hypotension. Additionally, dermatomal coverage may be greater than for other types of blocks. In cadaveric studies the paravertebral spread of dye was found from T7-L5 , although an vivo study in healthy volunteers showed the paravertebral spread of the contrast solution only between T10-L1 at 1 hour after the block. It is noted that while these anatomical studies invariably show the spread of contrast or dye extending to the paravertebral space that spread may be limited in degree. Thus follows a point of significant controversy as to whether the paravertebral space is in fact the block's primary site of action or whether it acts primarily on nerves, radicular and sympathetic, situated in the thoracolumbar fascia. Questions of mechanism and site of action notwithstanding, the safety and clinical efficacy of this block has been clearly demonstrated in multiple types of surgeries including abdominal laparoscopic , open laparotomy , urologic , and general surgery with analgesia lasting roughly 24 hours, decreased consumption of opioids, decreased time to ambulation, and decreased hospital length of stay. In recent studies, QL block employment was shown to produce a significant reduction in length of stay during hip surgery as well as similar analgesia to Lumbar Plexus blockade.
The quadratus lumborum block has since 2016 become standard of care for abdominal and hip surgeries at our institution, replacing paravertebral and lumbar plexus blocks respectively, and as part of a broader multimodal analgesia institutional ERAS (Enhanced Recovery After Surgery) protocol. Coincident with its implementation we have seen significant reductions in opiate and PCA use as well as hospital length of stay. Similar results have been reported by other institutions.
Since the first description of this technique, several approaches to and anatomic targets within the quadratus lumborum plane have been described although their mechanism of action, spread, and relative clinical effectiveness remain areas of some debate. There remain many unanswered questions regarding this block and its subtypes. It is, for example, unknown if one technique would be better than another for different types of surgery. Likewise little is known of the relative importance of local anesthetic concentration and injectate volume - the principal question addressed by this proposed study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
20 mL 0.375% Bupivacaine
Other names: Low Volume
Each block of 0.375% Bupivacaine x 20 ml mixed (diluted) with Normal Saline Solution 20 mL (total 40 mL)
Other names: High Volume
Time frame: 24 hours
Opioids administered to the patient in 24 hours, measured as averaged morphine milligram equivalent
Time frame: 3-hours
pain scores at rest at 3 hours after surgery (minimum 0 - maximum 10)
Time frame: 6-hours
pain scores at rest at 6 hours after surgery (minimum 0 - maximum 10)
Time frame: 12-hours
pain scores at rest at 12 hours after surgery (minimum 0 - maximum 10)
Time frame: 24-hours
pain scores at rest at 24 hours after surgery (minimum 0 - maximum 10)
Time frame: Post-operative 12-32 hours
Time to ambulation after surgery (ability to walk 100 feet).
Time frame: 24 hours
Time to consumption of the first opioid after surgery.
Time frame: Post-operative day 1 to post-operative day 5
Time to hospital discharge following surgery, measured in minutes
Anna Uskova
Other
Volume Versus Concentration: A Prospective, Double Blind, Parallel Study to Compare the Clinical Effectiveness of Single Shot Quadratus Lumborum Block Using Either a High Volume/Low Concentration or Low Volume/High Concentration Injectate for Total Hip Arthroplasty.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07735884
Acute Pain, Femoral Fractures
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT07335159
Acute Pain, Agnosia
Tallahassee, Florida, United States
View Trial DetailsNCT07500454
Acute Pain, Neurologic Manifestations
Mexico City, Mexico
View Trial DetailsNCT05229055
Acute Pain, Neurologic Manifestations
Monastir, Tunisia
View Trial Details