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NCT04591353 · ClinicalTrials.gov registry record · Phase 3
Trial Comparing Impact of PENG Block on Quality of Recovery Compared to No-block for Primary Total Hip Arthroplasty
A Phase 3 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 3
- Development phase
- 122
- Enrollment target
NCT04591353: Completed Phase 3 study, sponsored by University of Alabama at Birmingham.
NCT04591353 is a Phase 3 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 122 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04591353, a Phase 3 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 122 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Lidocaine
- DRUG PENG Block
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2022-11-01 |
| Phase | Phase 3 |
What the finished NCT04591353 record still lists
NCT04591353 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Lidocaine is the first listed.
NCT04591353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04591353 about?
NCT04591353 is a clinical study titled "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 wea...
What is the current status of trial NCT04591353?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 2021-02-01. Estimated completion is 2022-11-01.
What interventions are being tested in trial NCT04591353?
The interventions under investigation include: Lidocaine (DRUG), PENG Block (DRUG).
Who is sponsoring clinical trial NCT04591353?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04591353's enrollment target sits among peer trials
122 1617th of 2000 higher than 382 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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