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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 is a Phase 3 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 122 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04591353
The ClinicalTrials.gov registry entry for NCT04591353 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lidocaine is the first listed.
NCT04591353 reports 0 study locations.
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.
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