Trial Comparing Impact of PENG Block on Quality of Recovery Compared to No-block for Primary Total Hip Arthroplasty

NCT04591353 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: IRB-300006163
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Total Hip Arthroplasty

Keywords

PENG; THA; nerve blocks

Outcome Measures

Primary Outcomes (1)

• Recovery After Total Hip Arthroplasty

  The quality of recovery-15 is a validated questionnaire to assess postoperative recovery. I Scale is based on 15 questions, each question score range is 0-10 (0 being poor and 10 being excellent) The survey will be conducted at 24 hours after surgery Total score range is 0-150, where a score of 0 would be the worst possible score, and 150 would be the best possible score.

  24 hours after surgery

Secondary Outcomes (5)

• Evaluating Recovery After Total Hip Arthroplasty

  2 days after surgery

• Average Pain Medicine Required After Surgery.

  24 and 48 hours after surgery

• Pain Scores After Surgery

  Recovery (PACU), 6, 12, 24 and 48 hours after surgery

• Ambulation Distance After Surgery

  24 and 48 hours after surgery

• Total Patients Using Antiemetics After Surgery

  up to 2 days after surgery

Study Arms (2)

Investigational group ("PENG Block" group)

EXPERIMENTAL

Participants in the pericapsular nerve group block (PENG) arm will receive a PENG block preoperatively in the block area placed under direct ultrasound guidance as follows: Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area Anatomical landmarks identified using ultrasound and skin will be numbed using 2-3 cc of 2% lidocaine. Long acting local anesthetic, a bolus of 25 cc of 0.5 % Bupivacaine will be injected lateral to iliopubic eminence (IPE). A Curvilinear low frequency (2-5 MHz) ultrasound probe will be used to identify landmarks. A 22 G, 10 cm needle will be inserted using in-plane technique and advanced to target site (17).

Drug: PENG Block

Control group

ACTIVE COMPARATOR

Control group participants will be transferred to the block area preoperatively, and care will proceed as if they were receiving injection. Patients will be placed in the supine position resting comfortably. Standard noninvasive monitors will be applied, and oxygen will be administered via nasal cannula. Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area. The ultrasound probe will be used to identify the iliopubic eminence (IPE). Only skin will be numbed using 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.

Drug: Lidocaine

Interventions

PENG Block DRUG

The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties.

Investigational group ("PENG Block" group)

Lidocaine DRUG

2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (1)

• Kukreja P, Uppal V, Kofskey AM, Feinstein J, Northern T, Davis C, Morgan CJ, Kalagara H. Quality of recovery after pericapsular nerve group (PENG) block for primary total hip arthroplasty under spinal anaesthesia: a randomised controlled observer-blinded trial. Br J Anaesth. 2023 Jun;130(6):773-779. doi: 10.1016/j.bja.2023.02.017. Epub 2023 Mar 22.

  PMID: 36964012 DERIVED

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Promil Kukreja
• Organization: University of Alabama at Birmingham

Pkukreja@uab.edu

205-934-4042

Study Officials

• Shana Graves

  UAB shannagraves@uabmc.edu

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: February 1, 2021
• Primary Completion: September 15, 2022
• Study Completion: November 1, 2022
• Last Updated: February 15, 2024
• Results First Posted: February 17, 2023

Record last verified: 2023-07

Locations

US (2)