Trial Comparing Impact of Peri-capsular Nerve Group (PENG) Block on Quality of Recovery Compared to No-block for Primary Total Hip Arthroplasty

• Status: Recruiting
• Trial end date: 2022-01-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Lidocaine

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