- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03801265
Lumbar Plexus vs Quadratus Lumborum Block in Post-operative Pain Following Total Hip Replacement
A Prospective, Randomized, Double-blinded, Active-comparator, Non-inferiority Study to Observe Relative Efficacy of Ultrasound-guided Transmuscular Quadratus Lumborum Block Versus Class Lumbar Plexus Block in Managing Post-operative Pain Following Total Hip Replacement Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Eligible patients will be approached for the study by the PI or Sub-I in the pre-operative area on their day of surgery. The anesthesiology investigator will speak with the patient about the study behind a closed drape and the patient will have adequate time to consider the consent and ask questions regarding risk factors associated with each type of block. Once consented, the patient will be randomized by computer generated random number to one of the two treatment groups. Once assigned the treatment allocation, only the clinician administering the block will be unblinded to the randomization outcome. If randomized to the LP block, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 1 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.If randomized to the QL3 block, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach:Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. For both treatment groups, the local anesthetic used will be 100 mg 0.5% ropivacaine. After surgery, the patient will be followed by the blinded research team for incidence of adverse events, as well as the collection of the primary outcome measures. These include pain at rest and with movement at 6, 12 and 24 hours after surgery, time for first request for pain medication, total pain medications (narcotics and non-narcotic analgesics) given in 24 hours and the time of participant's ability to walk 100 feet as recorded by physical therapist. This information will be captured from the patient's electronic medical record.
Minor changes were made to the outcome measures after the original approval of this submission. This was only to clarify the specific measures from the more general descriptions in the original.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- UPMC Presbyterian-Shadyside Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients 18-90 years old
- Primary unilateral total hip arthroplasty
- BMI 20 - 36
- Male and Female
- All races
Exclusion Criteria:
- Patient refusal
- ASA class > or = 4
- Pregnancy
- Any condition precluding patient going home with in 24 hours of surgery
- Non-English speaking or inability to participate in the study
- Patients with coagulopathy or on therapeutic anticoagulation
- Chronic Steroid Use
- Narcotic Addiction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lumbar Plexus block
0.5% ropivacaine 100 mg (20 ml) will be injected
|
Patient will be positioned in lateral decubitus position with side to be blocked facing upwards.
Midline will be identified by palpating the spinous process.
Intercristal line will be drawn connecting iliac crests.
The point of needle insertion will be 4 cm lateral to the intersection of both lines.
The transverse process will first contact with a finder needle.
Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process.
Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained.
Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.
0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
|
Experimental: Quadratus Lumborum type 3 block
0.5% ropivacaine 100 mg (20 ml) will be injected
|
0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
Patient will be placed in a lateral position with the side to be blocked facing up.
A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly.
The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle.
Psoas muscle is then identified lying anterior to the QL muscle.
A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain at Rest After Surgery
Time Frame: 6 hours after surgery
|
Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest.
A higher score means worse outcomes.
|
6 hours after surgery
|
Pain With Movement After Surgery
Time Frame: 6 hours after surgery
|
Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement.
A higher score means worse outcomes.
|
6 hours after surgery
|
Pain at Rest After Surgery
Time Frame: 12 hours after surgery
|
Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest.
A higher score means worse outcomes.
|
12 hours after surgery
|
Pain With Movement After Surgery
Time Frame: 12 hours after surgery
|
Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement.
A higher score means worse outcomes.
|
12 hours after surgery
|
Pain at Rest After Surgery
Time Frame: 24 hours after surgery
|
Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest.
A higher score means worse outcomes.
|
24 hours after surgery
|
Pain With Movement After Surgery
Time Frame: 24 hours after surgery
|
Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement.
A higher score means worse outcomes.
|
24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain During Physical Therapy
Time Frame: 24 hours after surgery
|
Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement.
A higher score means worse outcomes.
|
24 hours after surgery
|
Total Opioid Consumption During 24 Hours After Surgery
Time Frame: 24 hours after surgery
|
Narcotics will be converted to oral morphine equivalents
|
24 hours after surgery
|
Postoperative Time to Accomplish Walking 100 Feet
Time Frame: within 24 hours after surgery
|
This measurement is from T0 being out of surgery room time to the point at which the participant was able to walk 100 feet during the first day post-surgery.
Values were abstracted from the patient medical records.
|
within 24 hours after surgery
|
Block Procedure Duration
Time Frame: during surgery
|
Duration that the patient underwent the block procedure during surgery in minutes
|
during surgery
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Patients With Postoperative Quadriceps Weakness
Time Frame: 12 hours after surgery
|
patients who report having post-surgical quadriceps weakness.
|
12 hours after surgery
|
Total Acetaminophen Consumption During 24 Hours After Surgery
Time Frame: 24 hours after surgery
|
Patient electronic medical records were reviewed for total acetaminophen consumption during 24 hours after surgery in milligrams (mg)
|
24 hours after surgery
|
Total Celecoxib Consumption During 24 Hours After Surgery
Time Frame: 24 hours after surgery
|
Patient electronic medical records were reviewed for total celecoxib consumption during 24 hours after surgery in milligrams (mg)
|
24 hours after surgery
|
Total Ketorolac Consumption During 24 Hours After Surgery
Time Frame: 24 hours after surgery
|
Patient electronic medical records were reviewed for total ketorolac consumption during 24 hours after surgery in milligrams (mg)
|
24 hours after surgery
|
Total Gabapentin Consumption During 24 Hours After Surgery
Time Frame: 24 hours after surgery
|
Patient electronic medical records were reviewed for total gabapentin consumption during 24 hours after surgery in milligrams (mg)
|
24 hours after surgery
|
Total Oral Ketamine Consumption During 24 Hours After Surgery
Time Frame: 24 hours after surgery
|
Patient electronic medical records were reviewed for total oral ketamine consumption during 24 hours after surgery in milligrams (mg)
|
24 hours after surgery
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Opioid Consumption During 0-6 Hours After Surgery
Time Frame: 6 hours after surgery
|
Narcotics will be converted to oral morphine equivalents
|
6 hours after surgery
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Opioid Consumption During 6-12 Hours After Surgery
Time Frame: 6-12 hours after surgery
|
Narcotics will be converted to oral morphine equivalents
|
6-12 hours after surgery
|
Opioid Consumption During 12-24 Hours After Surgery
Time Frame: 12-24 hours after surgery
|
Narcotics will be converted to oral morphine equivalents
|
12-24 hours after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sharad Khetarpal, MD, Department of Anesthesiology, University of Pittsburgh Medical Center
Publications and helpful links
General Publications
- Hockett MM, Hembrador S, Lee A. Continuous Quadratus Lumborum Block for Postoperative Pain in Total Hip Arthroplasty: A Case Report. A A Case Rep. 2016 Sep 15;7(6):129-31. doi: 10.1213/XAA.0000000000000363.
- Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.
- Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.
- La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406.
- Weller RS, Gerancher JC, Crews JC, Wade KL. Extensive retroperitoneal hematoma without neurologic deficit in two patients who underwent lumbar plexus block and were later anticoagulated. Anesthesiology. 2003 Feb;98(2):581-5. doi: 10.1097/00000542-200302000-00044. No abstract available.
- Ilfeld BM, Ball ST, Gearen PF, Le LT, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Meyer RS. Ambulatory continuous posterior lumbar plexus nerve blocks after hip arthroplasty: a dual-center, randomized, triple-masked, placebo-controlled trial. Anesthesiology. 2008 Sep;109(3):491-501. doi: 10.1097/ALN.0b013e318182a4a3.
- Børglum J, Moriggl B, Jensen K, Lønnqvist P, Christensen AF, Sauter A, Bendtsen TF. Ultrasound-guided transmuscular quadratus lumborum blockade. British Journal of Anaesthesia 111:eLetters Supplement, 2013.
- Winnie AP, Ramamurthy S, Durrani Z, Radonjic R: Plexus blocks for lower extremity surgery: New answers to old problems. Anesth Review 1974; 1:11
- Polania Gutierrez JJ, Ben-David B, Rest C, Grajales MT, Khetarpal SK. Quadratus lumborum block type 3 versus lumbar plexus block in hip replacement surgery: a randomized, prospective, non-inferiority study. Reg Anesth Pain Med. 2021 Feb;46(2):111-117. doi: 10.1136/rapm-2020-101915. Epub 2020 Nov 11.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Pain, Postoperative
- Osteoarthritis, Hip
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Ropivacaine
Other Study ID Numbers
- PRO18120275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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