Lumbar Plexus Block Versus Quadratus Lumborum Block for Primary Anterior Total Hip Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Lumbar Plexus Block Versus Quadratus Lumborum Block for Primary Anterior Total Hip Arthroplasty: A Non-inferiority Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409900
• Other study ID #: IRB00048845
• Status: Completed
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: November 22, 2019

Study information

• Verified date: March 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Total hip arthroplasty (THA) is one of the most successful orthopedic procedures to effectively relieve pain and restore function in patients with end stage osteoarthritis. In an attempt to accelerate recovery many orthopedic surgeons have opted to utilize a direct anterior approach (DAA) as opposed to the more traditional posterolateral approach (PLA). The literature supports that DAA is superior to PLA with regard to lower blood loss, less pain, shorter hospital stay, and faster rehabilitation. Traditionally the study team has performed Lumbar Plexus blocks (LPB) to provide post-operative analgesia for total hip arthroplasty. The quadratus lumborum block (QLB) is a newer regional analgesic technique that may be as effective as LPB at providing pain control following DAA hip arthroplasty. This study is designed to compare the efficacy, with regards to post-operative pain management, between LPB and QLB following a DAA total hip arthroplasty.

Description:

In an attempt to accelerate recovery many orthopedic surgeons have opted to utilize a direct anterior approach (DAA) as opposed to the more traditional posterolateral approach (PLA) in regards to total hip arthroplasty (THA). The DAA technique involves dissection of muscular planes for insertion of components resulting in less tissue damage as compared to PLA. Traditionally the study team has performed Lumbar Plexus blocks (LPB) to provide post-operative analgesia for total hip arthroplasty. This technique works well for the traditionally performed PLA in that the hip joint and incision site are within the analgesic distribution of the LPB. Conversely, the DAA utilizes an anterior incision that overlies the L1 and L2 dermatomes as opposed to the lower lumbar dermatomes of the PLA incision. When performing LPB it has been the study team's clinical experience that it is rare to achieve analgesia in the proximal distribution of the lumbar plexus resulting in apparent sparing of the L1 and L2 nerve root distributions. The quadratus lumborum block (QLB) is a newer regional analgesic technique that may be as effective as LPB at providing pain control following DAA hip arthroplasty. The QLB is thought to provide analgesia by blocking both the lateral and anterior cutaneous branches of T7 through L4. This degree of dermatomal coverage suggests that QLB could be an efficacious alternative to LPB for DAA hip arthroplasty. It is hypothesized that the QLB will provide equivalent analgesia when compared to the LPB as determined by a comparison of verbal reported pain scores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Any patient between the ages of 18 and 95 years undergoing a primary elective, unilateral DAA total hip arthroplasty.

Exclusion Criteria:

• If the patient uses more than 40mg of Oxycodone equivalents per 24 hours or is on extended release opioid formulations.

• Indication for surgery is secondary to trauma and/or hip fracture

• If there is a contraindication to the performance of a regional block

• Concomitant anticoagulation use or documented coagulopathy

• Infectious or dermatologic conditions in the area of block placement that would otherwise increase the risk of peripheral nerve blockade

• Presence of progressive neurologic deficit effecting peripheral nerves

• Allergy or adverse reaction to study drugs to include: fentanyl, epinephrine, and amide local anesthetics

• American Society of Anesthesia Physical Classification score > or = to 4

• Allergies to study drugs other than local anesthetic

• BMI > 40

• Patient refusal

• Pregnancy

• Institutionalized individuals

• Extremes of age: Age > 95 or < 18

• Non English speaking or inability to reliably participate in the study

Related Conditions & MeSH terms

• Osteoarthritis
• Total Hip Arthroplasty

Intervention

Other:
• LPB
The LPB will be performed in a lateral position, but modified to utilize ultrasound guidance to enhance our ability to quickly and safely locate the lumbar plexus as well as to avoid unblinding with regard to the traditional landmark LPB technique. For both LPB and QLB a TOTAL DOSE of 20 cc of the following local anesthetic mixture will be administered: Ropivacaine 0.2% and Epinephrine - 2.5 mcg/cc (1:400,000 concentration).
• QLB
The QLB will be performed in a lateral position in a manner consistent with the technique first described by Børglum. For both LPB and QLB a TOTAL DOSE of 20 cc of the following local anesthetic mixture will be administered: Ropivacaine 0.2% and Epinephrine - 2.5 mcg/cc (1:400,000 concentration).

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verbal numeric pain score with hip flexion at 6hrs (Numeric Rating Scale (NRS))	Quantified on an 10 point pain scale with 0 representing "no pain" and 10 representing "worst pain imaginable". Higher scores denotes worse outcomes.	6 hours post block
Secondary	Time to first analgesic	Time from PACU discharge to first requested analgesic	During hospitalization, up to 24hrs
Secondary	Total opioid consumption over 24 hours	Total opioid consumption in the first 24hrs	24 hrs post block
Secondary	Verbal numeric pain score at 6hrs at rest (NRS)	Quantified on an 10 point pain scale with 0 representing "no pain" and 10 representing "worst pain imaginable". Higher scores denotes worse outcomes.	6hrs post block
Secondary	Verbal numeric pain score at rest and with movement at 24hrs post block	Quantified on an 10 point pain scale with 0 representing "no pain" and 10 representing "worst pain imaginable". Higher scores denotes worse outcomes.	24hrs post block
Secondary	Ability to straight leg raise on POD1	Is the patient able to perform an unassisted straight leg raise	Post operative day 1
Secondary	Rates of opioid related side effects (nausea, vomiting, pruritis)	Has the patient had any nausea, vomiting, or pruritis within the first 24hrs	Within 24hrs post block
Secondary	Patient satisfaction utilizing a Likert-scale questionnaire	A patient satisfaction survey to administered on post operative day 1	Post operative day 1