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SurgeryNCT04402437

QL vs LP Blocks for Analgesia Following THA

A study testing LP Block and QL Block in people with Surgery, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose: Evaluate difference in postoperative opioid consumption when subjects receive a quadratus lumborum (QL) or lumbar plexus (LP) block preoperatively for total hip arthroplasty (THA). Hypothesis: Preoperative QL and LP blocks will result in similar postoperative opioid consumption following hip arthroplasty. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Surgery
What is being tested?
LP Block and QL Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
1 siteUnited States
Study dates
23 Jul 2020to 4 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age greater than or equal to 18 years-old
  • Undergoing elective hip arthroplasty.

Who cannot join

  • Local anesthetic allergy
  • Chlorhexidine allergy
  • Subjects with a weight less than 40kg
  • Subjects that are unable or choose not to give informed consent
  • Emergency surgery
  • Known preoperative substance abuse
  • Allergy to all opioids

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Utilization of Quadratus Lumborum Versus Lumbar Plexus Blocks for Postoperative Analgesia Following Hip Arthroplasty: A Prospective, Randomized Clinical Trial

Purpose: Evaluate difference in postoperative opioid consumption when subjects receive a quadratus lumborum (QL) or lumbar plexus (LP) block preoperatively for total hip arthroplasty (THA).

Hypothesis: Preoperative QL and LP blocks will result in similar postoperative opioid consumption following hip arthroplasty.

Read the detailed description

With the goal of improving physical function and quality of life, the demand for total hip arthroplasty (THA) continues to grow. However, postoperative pain associated with THA remains a serious concern for patients. In the middle of a growing opioid epidemic, multimodal approaches utilizing both non-opioid analgesics and regional anesthetic techniques are being increasingly sought.

Regional anesthetic techniques are associated with both decreased opioid consumption and pain scores compared with systemic analgesia alone. However, regional techniques for THA are seldom compared. Lumbar plexus blocks are commonly performed for postoperative analgesia for THA. However, more recent case reports have described utilizing quadratus lumborum blocks for analgesia following hip fracture and THA.

This prospective study would randomize subjects to receive a lumbar plexus block or quadratus lumborum block prior to THA. The primary end point would be opioid consumption at 12 hours postoperative. Our hypothesis is that opioid consumption will not differ between groups.

The quadratus lumborum block is a fascial plane block. Originally described for abdominal surgery, numerous case reports and editorial publications have highlighted the effectiveness of quadratus lumborum (QL) blocks as an analgesic technique for hip fracture and hip arthroplasty. However, prospective randomized studies comparing QL blocks to other regional techniques for THA analgesia are lacking.

The lateral approach to the QL block is performed by injecting local anesthetic deep to the transversus abdominus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. After completing consent, placing monitors and providing mild sedation, the subject is positioned laterally and the muscular anatomy (external oblique, internal oblique, transverse abdominis, quadratus lumborum and latissimus dorsi muscles) identified. After placing a subcutaneous skin wheal with lidiocaine, a blunt regional anesthesia needle is inserted using in-plane ultrasound guidance. Local anesthetic is deposited incrementally with frequent aspiration in the anterolateral border of the quadratus lumborum muscle at the junction of the transversalis fascia, outside the anterior layer of the thoracolumbar fascia and superficial to the fascia transversalis.

Risks of anterior approach to the quadratus lumborum block are similar to most truncal blocks and include infection, bleeding, bowel perforation or local anesthetic toxicity (LAST). Infection risk is minimized by utilizing appropriate antiseptic and sterile technique as is standard for any regional procedure. Risk of a retroperitoneal hematoma is increased with the posterior approach to the quadratus lumborum block because of its transmuscular approach and likelihood of abdominal branches of lumbar arteries in the path of the needle. For this reason, the posterior approach to the quadratus lumborum block will not be used for this study. The risk of LAST is a risk with any regional procedure and is minimized by frequent aspiration, incremental local anesthetic injection and vital signs monitoring throughout.

The quadratus lumborum block is already a block utilized for a variety of surgical procedures to decrease postoperative pain. Potential benefits to the QL block over the common lumbar plexus block include more superficial block placement and ultrasound visualization. The investigator hypothesize that preoperative QL blocks will reduce opioid consumption similar to lumbar plexus blocks following elective hip arthroplasty.

Information regarding the study will be presented to subjects in the surgical clinic or preoperative anesthesia clinic in the preoperative period. Subjects will be educated on the role of regional anesthesia in postoperative analgesia. Subjects will be able to consider the study until the day of surgery. On the day of surgery, subjects may then choose to provide written consent or decline to participate.

Subjects will be enrolled on the day of surgery in the preoperative holding area.

After discussion in the preoperative holding area regarding risks and benefits of both the lumbar plexus and QL block, subjects will be consented if they choose to participate. Consent will be obtained from subject by an IRB approved CITI certified study team member that has been trained on the protocol. Written consent with a witness will be completed once all questions are answered and exclusion and inclusion verified. Copies of all documents will be provided to the subjects. Once subjects are consented, they will be assigned an enrollment number. Prior to subject enrollment, randomization will done by a statistician and randomized group (lumbar plexus block (current practice) or QL block) assigned based on the subject enrollment number.

Design: This prospective, single blinded clinical trial will randomize subject to receive a lumbar plexus or QL block prior to THA. The randomization will be created by a statistician prior to subject enrollment.

Groups: Subjects will be randomized to receive a preoperative lumbar plexus (n = 100) or QL (n = 100 ) block prior to THA.

Potential participants that are on the operating room schedule for THA will be screened for eligibility via chart review.

Once subjects have signed an informed consent, they will be assigned an enrollment number. Numbers would be assigned sequentially with the first enrolled subject receiving "001," the second subject receiving "002," and the last subject receiving number "184." Randomization will be created prior to the study starting by a statistician with half of the research subject number being assigned to receive a QL block and the other half assigned to receive a lumbar plexus block, which is our current standard of care. The regional anesthesia team will open the envelope labeled with the subject's assigned number to reveal the randomization.

Following informed consent, all subjects will be positioned, prepped and sedated for the randomized regional anesthesia procedure in the preoperative holding area. The subject will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. As part of routine care, the subject will receive sedation for their comfort. All subjects would receive 20 ml of 0.5% ropivacaine in their nerve block regardless of randomization. The relevant anatomy will then be identified using either surface landmarks (lumbar plexus block) or an ultrasound (quadratus lumborum block). All participants, regardless of group assignment, will be positioned, have an area on their back and side cleaned, have an ultrasound placed, and numbing medication placed just below the skin at both block sites (skin wheal). This will be done so that participant and the team collecting result will be blinded. Subject, surgeon, intraoperative anesthesia team and data collectors would all be blinded to the allocated group.

Subjects randomized to the lumbar plexus block group will receive a subcutaneous lidocaine skin wheal 3-4 cm lateral to midline on the operative side along the intercristal line. A nerve stimulator will be sent to 1-1.5mA and a stimulating needle inserted perpendicular to the skin. The needle will be advanced slowly until the quadriceps muscle is stimulated and maintained at less than 0.6mAs. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement.

Subjects randomized to the quadratus plexus block group will receive a subcutaneous lidocaine skin wheal that will be placed after ultrasound identification of external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A needle will then be advanced under ultrasound guidance below the internal oblique aponeurosis and lateral to the quadratus lumborum muscle. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement. Local anesthetic injection will also be observed with real time ultrasound guidance.

The participant's chart will be reviewed for data collection.

Participants will also be asked to perform a Visual Analog Scale pain score preoperatively (baseline), postoperatively (once awake) and approximately 24 hours post operatively.

Care in the perioperative period will otherwise be standardized. In the post-anesthesia care unit (PACU), hydromorphone or morphine will be titrated by the PACU nurse for the subject's comfort.

Conditions
Surgery
Being tested
LP Block, QL Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LP BlockProcedure or surgery

    Subjects randomized to the lumbar plexus block group will receive a subcutaneous lidocaine skin wheal 3-4 cm lateral to midline on the operative side along the intercristal line. A nerve stimulator will be sent to 1-1.5mA and a stimulating needle inserted perpendicular to the skin. The needle will be advanced slowly until the quadriceps muscle is stimulated and maintained at less than 0.6mAs. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement.

  • QL BlockProcedure or surgery

    Subjects randomized to the quadratus plexus block group will receive a subcutaneous lidocaine skin wheal that will be placed after ultrasound identification of external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A needle will then be advanced under ultrasound guidance below the internal oblique aponeurosis and lateral to the quadratus lumborum muscle. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement. Local anesthetic injection will also be observed with real time ultrasound guidance.

Study groups in NCT04402437
Study groupRoleWhat they receive
Receives LP BlockActive comparatorSubjects randomized to the lumbar plexus block group will receive a subcutaneous lidocaine skin wheal 3-4 cm lateral to midline on the operative side along the intercristal line. A nerve stimulator will be sent to 1-1.5mA and a stimulating needle inserted perpendicular to the skin. The needle will be advanced slowly until the quadriceps muscle is stimulated and maintained at less than 0.6mAs. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement.
Receives: Procedure: LP Block
Receives QL BlockActive comparatorSubjects randomized to the quadratus plexus block group will receive a subcutaneous lidocaine skin wheal that will be placed after ultrasound identification of external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A needle will then be advanced under ultrasound guidance below the internal oblique aponeurosis and lateral to the quadratus lumborum muscle. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement. Local anesthetic injection will also be observed with real time ultrasound guidance.
Receives: Procedure: QL Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid consumption

    Opioid consumption including intraoperative consumption

    Measured: 12 hours

Secondary outcomes (1)
  1. Opioid consumption 8 hours postoperative

    Opioid consumption including intraoperative consumption

    Measured: 8 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2020
  2. Study start23 Jul 2020
  3. Primary completion4 Jun 2021
  4. Study completion4 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The subject will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. As part of routine care, the subject will receive sedation for their comfort. All subjects would receive 20 ml of 0.5% ropivacaine in their nerve block regardless of randomization. The relevant anatomy will then be identified using either surface landmarks (lumbar plexus block) or an ultrasound (quadratus lumborum block). Surface anatomy will be marked with a marking pen for both groups to keep the intraoperative and surgical team blinded. The skin will be cleaned with chlorhexidine.
Masking
Single blind
Who is masked
Participant
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04402437
Sponsor's protocol ID
Pro00098482
Status last verified
Aug 2022
First submitted
20 May 2020
Last updated
2 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7.

    PubMed 17964352
  • Bruyere O, Ethgen O, Neuprez A, Zegels B, Gillet P, Huskin JP, Reginster JY. Health-related quality of life after total knee or hip replacement for osteoarthritis: a 7-year prospective study. Arch Orthop Trauma Surg. 2012 Nov;132(11):1583-7. doi: 10.1007/s00402-012-1583-7. Epub 2012 Jul 28.

    PubMed 22842917
  • Ethgen O, Bruyere O, Richy F, Dardennes C, Reginster JY. Health-related quality of life in total hip and total knee arthroplasty. A qualitative and systematic review of the literature. J Bone Joint Surg Am. 2004 May;86(5):963-74. doi: 10.2106/00004623-200405000-00012.

    PubMed 15118039
  • Singh JA, Lewallen D. Predictors of pain and use of pain medications following primary Total Hip Arthroplasty (THA): 5,707 THAs at 2-years and 3,289 THAs at 5-years. BMC Musculoskelet Disord. 2010 May 13;11:90. doi: 10.1186/1471-2474-11-90.

    PubMed 20462458
  • Becchi C, Al Malyan M, Coppini R, Campolo M, Magherini M, Boncinelli S. Opioid-free analgesia by continuous psoas compartment block after total hip arthroplasty. A randomized study. Eur J Anaesthesiol. 2008 May;25(5):418-23. doi: 10.1017/S026502150700302X. Epub 2007 Nov 21.

    PubMed 18028577
  • Biboulet P, Morau D, Aubas P, Bringuier-Branchereau S, Capdevila X. Postoperative analgesia after total-hip arthroplasty: Comparison of intravenous patient-controlled analgesia with morphine and single injection of femoral nerve or psoas compartment block. a prospective, randomized, double-blind study. Reg Anesth Pain Med. 2004 Mar-Apr;29(2):102-9. doi: 10.1016/j.rapm.2003.11.006.

    PubMed 15029544
  • Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anaesthesia improve outcome after total hip arthroplasty? A systematic review. Br J Anaesth. 2009 Sep;103(3):335-45. doi: 10.1093/bja/aep208. Epub 2009 Jul 23.

    PubMed 19628483
  • Stevens RD, Van Gessel E, Flory N, Fournier R, Gamulin Z. Lumbar plexus block reduces pain and blood loss associated with total hip arthroplasty. Anesthesiology. 2000 Jul;93(1):115-21. doi: 10.1097/00000542-200007000-00021.

    PubMed 10861154
  • Harvey NR, Wolf BJ, Bolin ED, Wilson SH. Comparison of analgaesia with lumbar epidurals and lumbar plexus nerve blocks in patients receiving multimodal analgaesics following primary total hip arthroplasty: a retrospective analysis. Int Orthop. 2017 Nov;41(11):2229-2235. doi: 10.1007/s00264-017-3465-7. Epub 2017 Apr 11.

    PubMed 28396932
  • Wilson SH, Wolf BJ, Algendy AA, Sealy C, Demos HA, McSwain JR. Comparison of Lumbar Epidurals and Lumbar Plexus Nerve Blocks for Analgesia Following Primary Total Hip Arthroplasty: A Retrospective Analysis. J Arthroplasty. 2017 Feb;32(2):635-640. doi: 10.1016/j.arth.2016.07.042. Epub 2016 Aug 10.

    PubMed 27597428
  • Wilson SH, Auroux AS, Eloy JD, Merman RB, Chelly JE. Ropivacaine 0.1% versus 0.2% for continuous lumbar plexus nerve block infusions following total hip arthroplasty: a randomized, double blinded study. Pain Med. 2014 Mar;15(3):465-72. doi: 10.1111/pme.12309. Epub 2013 Dec 11.

    PubMed 24330381
  • 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.

    PubMed 27513972
  • Johnston DF, Sondekoppam RV. Continuous quadratus lumborum block analgesia for total hip arthroplasty revision. J Clin Anesth. 2016 Dec;35:235-237. doi: 10.1016/j.jclinane.2016.08.002. Epub 2016 Sep 26. No abstract available.

    PubMed 27871532
  • 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.

    PubMed 28036319
  • La Colla L, Uskova A, Ben-David B. Single-shot Quadratus Lumborum Block for Postoperative Analgesia After Minimally Invasive Hip Arthroplasty: A New Alternative to Continuous Lumbar Plexus Block? Reg Anesth Pain Med. 2017 Jan/Feb;42(1):125-126. doi: 10.1097/AAP.0000000000000523. No abstract available.

    PubMed 27997495

Questions about this trial

What is this clinical trial studying?

A study testing LP Block and QL Block in people with Surgery, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid consumption (time frame: 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04402437, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.

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