Trial Comparing Impact of PENG Block on Quality of Recovery Compared to No-block for Primary Total Hip Arthroplasty
Condition: Total Hip Arthroplasty
Intervention: PENG Block; Lidocaine
Intervention description: The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties.; 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Upon enrollment in the study, participants will be randomized 1:1 to either the investigational group ("PENG Block" group) or the control group ("No Block" group). Participants will be randomized using a random number generator. The randomization will be performed using computer-generated random numbers. The study will follow a 1:1 allocation ratio for the intervention (PENG) and control (No-PENG). A random permuted block will be used to reduce the predictability of allocation. The randomization sequence will be generated using computer software using a block randomization method where blocks are variable in size (minimum block size four). The study will use a sealed opaque envelope as method to comply with allocation concealment.
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PENG; THA; nerve blocks

Summary:

      Total hip arthroplasty (THA) is now the second most common joint replacement surgery in the
      US due in part to an aging population. Opioid sparing analgesic treatments such as lumbar
      plexus and femoral nerve blocks are effective but they carry a high risk of undesirable lower
      limb motor or muscle weakness. Fascia iliaca block, on the other hand, does not consistently
      provide adequate pain relief. Today, early mobilization, rehabilitation and participation in
      physical therapy is an integral part of enhanced functional recovery program after THA.
      Because innervation of the hip joint is complex and preservation of lower extremity motor
      function is paramount, optimal regional analgesic intervention for THA has yet to be defined.
      The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for
      providing analgesia after hip fractures and hip arthroplasties. Quality of recovery scores
      are patient reported outcome measures evaluating recovery after surgery and anesthesia. The
      quality of recovery-15 (QoR-15) is a validated questionnaire to assess postoperative
      recovery. The aim of this single center, double blind, randomized controlled trial is to
      confirm the efficacy of the PENG block for postoperative recovery after primary THA.

      Methods: The participants will be randomly assigned to either PENG block group or "no Block"
      group using a random number generator. The patient will be blinded to the group allocated.
      The primary outcome will be the quality of recovery 15 score (QoR-15). The secondary outcomes
      will be visual analog scale score of pain postoperatively, opioid requirements in first 24
      hours, ambulation distance on postoperative day1 and patient satisfaction. Statistical
      analysis will be performed using the student's t-test, Mann-Whitney U test, and Fisher's
      exact test as appropriate per sample. A p-value of less than 0.05 will be considered
      statistically significant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing primary total hip arthroplasty

          -  Patients >=18 years of age

          -  Patients with an American Society of Anesthesiology (ASA) physical status
             classification of I, II or III

          -  Primary THA (first THA operation in the patient's lifetime)

        Exclusion Criteria:

          -  Patients with ASA physical status classification 4 or above

          -  Patients with allergies/intolerances to local anesthetic

          -  Patients with pre-existing neurologic or anatomic deficits in the lower extremity on
             the side of the surgical site

          -  Patients on chronic opioid use or opioid tolerant (The FDA defines a patient as opioid
             tolerant if for at least 1 week he or she has been receiving oral morphine 60 mg/day;
             transdermal fentanyl 25 mcg/hour; oral oxycodone 30 mg/day; oral hydromorphone 8
             mg/day; oral oxymorphone 25 mg/day; or an equianalgesic dose of any other opioid)

          -  Poor understanding of English language.

          -  Patients with coexisting coagulopathy

          -  Patients that are pharmacologically anticoagulated will be excluded if placement of
             peripheral nerve block would be contraindicated according to ASRA (American Society
             for Regional Anesthesia) guidelines