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Total Hip ArthroplastyPhase 3(PENG)NCT04591353

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

A Phase 3 study testing PENG Block and Lidocaine in people with Total Hip Arthroplasty, run by University of Alabama at Birmingham at 2 sites 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

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Total Hip Arthroplasty
What is being tested?
PENG Block and Lidocaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
2 sitesUnited States
Study dates
1 Feb 2021to 1 Nov 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

Other trials in United States

About this study

Official title: A Randomized-controlled, Double-blind, Single-center Trial Comparing Impact of PENG Block on Quality of Recovery Compared to No-block for Primary Total Hip Arthroplasty

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.

Read the detailed description

As the practice of anesthesiology has grown increasingly safe, the focus has shifted to improving quality, as evidenced by the robust spread of Enhanced Recovery after Surgery protocols. The implications from poor quality recovery is vast, including prolonged stay in the recovery room or hospital. The Quality of Recovery (QoR-15) questionnaire is a method to measure five dimensions using 15 questions: physical independence, pain, comfort, patient support, emotional state. It is an extensively validated measure of patient-assessed quality of recovery after surgery, having been demonstrated over a variety of clinical settings. QoR-15 scores range from 0 (extremely poor quality of recovery) to 150 (excellent). Mean time to complete the 15-question survey is 3 minutes, a marker of its clinical utility. As we aim to improve our perioperative care and develop approaches to improve medicine in this regard, the QoR-15 provides a useful tool.

The effective postoperative analgesia is vital as acute surgical pain is a potential risk factor for future chronic pain. Persistent pain after THA (more than three months) is reported in 27% of patients and is reported to be correlated with the intensity of early postoperative pain rather than preoperative pain levels. Utilizing regional anesthesia helps to limit the use of opioids, however, which technique is best has yet to be determined. The lumbar plexus blocks, lumbar epidurals, and femoral nerve blocks have been associated with motor weakness. Fascia iliaca compartment block (FICB) has not been found to predictably decrease pain intensity or opioid use. Quadratus lumborum (QL) block is a relatively new regional block found to provide effective analgesia after primary THA, but it can indirectly block lumbar plexus branches and may cause some motor weakness. It is also a deep block and therefore contraindicated in patients on anticoagulation.

Recent anatomic studies confirmed the innervation of the anterior capsule of hip joint to be the obturator nerve, accessory obturator nerve, and femoral nerve. These studies also evaluated the relationship with these nerves and other bony or soft tissue landmarks visible by ultrasound guidance. Previous studies have found histologically that the anterior capsule has predominantly nociceptive fibers, while the posterior capsule is largely made up of mechanoreceptors. The pericapsular nerve group (PENG) block was introduced to target and block these articular branches providing innervation to the hip. Given the case reports showing the efficacy of PENG blocks for hip fracture surgeries, we sought to investigate the analgesic efficacy of PENG blocks for primary and revision THAs. The PENG block targets only the sensory branches and not the posterior mechanoreceptors; there is a potential motor-sparing effect which is desirable for early ambulation, better physical therapy, and earlier discharge. The effective analgesia and early ambulation provided by such regional anesthesia block may have positive impact on patient's mood, sleep, appetite and overall feeling of well-being. A similar postoperative recovery study protocol has been proposed for anterior quadratus lumborum blocks for THA. It remains unclear whether PENG block provides sufficient analgesia and improves the quality of post-operative recovery after primary THA.

The ideal regional anesthesia technique for THA will provide adequate postoperative analgesia, reduced opioid requirements, early ambulation and physical independence. The aim of this single center, double blind RCT is to confirm the efficacy of PENG block for postoperative recovery with respect to parameters mentioned above.

Being tested
PENG Block, Lidocaine
Keywords
PENG, THA, nerve blocks

What participants receive

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

  • PENG BlockDrug

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

  • LidocaineDrug

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

Study groups in NCT04591353
Study groupRoleWhat they receive
Investigational group ("PENG Block" group)ExperimentalParticipants 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).
Receives: Drug: PENG Block
Control groupActive comparatorControl 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.
Receives: Drug: Lidocaine

What is being measured

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

  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.

    Measured: 24 hours after surgery

Secondary outcomes (5)
  1. Evaluating Recovery After Total Hip Arthroplasty

    Quality of recovery (QoR) survey at 48 hours after surgery. QoR-15 scores range from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery).

    Measured: 2 days after surgery

  2. Average Pain Medicine Required After Surgery.

    Measuring the average milligrams of oral morphine equivalent (OME) consumption at 24 and 48 hours after surgery

    Measured: 24 and 48 hours after surgery

  3. Pain Scores After Surgery

    Pain scores (visual analog scores VAS) in recovery (PACU), 6, 12, 24 and 48 hours after surgery

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

  4. Ambulation Distance After Surgery

    ambulation distance as recorded by physical therapist at 24 and 48 hours after surgery

    Measured: 24 and 48 hours after surgery

  5. Total Patients Using Antiemetics After Surgery

    use of any medication for nausea or vomiting prevention after surgery

    Measured: up to 2 days after surgery

Timeline

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

  1. First posted19 Oct 2020
  2. Study start1 Feb 2021
  3. Primary completion15 Sep 2022
  4. Study completion1 Nov 2022

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04591353
Sponsor's protocol ID
IRB-300006163
Acronym
(PENG)
Status last verified
Jul 2023
First submitted
9 Oct 2020
Last updated
15 Feb 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 36964012

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PENG Block and Lidocaine in people with Total Hip Arthroplasty, run by University of Alabama at Birmingham at 2 sites 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 4 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 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Recovery After Total Hip Arthroplasty (time frame: 24 hours after surgery). 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 NCT04591353, which also lists 1 linked publication.

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 15 Feb 2024.

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