Meta description: Regulators monitor a not yet recruiting trial of ultrasound guided Quadro Iliac Plane Block after total hip arthroplasty, led by Bursa City Hospital, for postoperative pain relief.
The ClinicalTrials.gov record NCT07410000 lists pain management after hip arthroplasty as the condition and two interventions namely Quadro Iliac Plane Block and a Sham Block. The sponsor is Bursa City Hospital. The trial record is accessible via the ClinicalTrials.gov link and illustrates an investigational procedure rather than a marketed device at this stage.
What is the Quadro Iliac Plane Block?
The Quadro Iliac Plane Block is described as an ultrasound guided procedure intended to provide analgesia after total hip arthroplasty. The term used in the source text is Quadro Iliac Plane Block with the acronym QIP. The procedure seeks to place a local anesthetic in a regional plane around the iliac region to reduce postoperative pain, potentially enabling faster mobilization. The trial compares QIP Block to a Sham Block in a not yet recruiting study sponsored by Bursa City Hospital. The source record appears on ClinicalTrials.gov under NCT07410000. The intervention is a procedure rather than a device per se, and the trial aims to produce data on safety and analgesic performance. For context the topic is part of a broader effort to optimize pain management after hip replacement beyond conventional systemic analgesia and nerve blocks. See related coverage in our upstream posts on ultrasound guided regional anesthesia and hip arthroplasty pain management.
Study context and regulatory status
The trial addresses postoperative analgesia after total hip arthroplasty. The record indicates Not yet recruiting. The sponsor is Bursa City Hospital. The study lists the two arms: QIP Block and Sham Block. The objective is to compare analgesic performance and safety, with no explicit efficacy claims in the source text at this stage. In regulatory terms the entry aligns with early stage clinical investigation and does not imply regulatory clearance for a marketed device or procedure. Data readiness for any future regulatory submission will depend on trial results protocol details and adherence to applicable MDR guidance as reflected in the Annex XIV framing used by the sponsor.
Trial design and status
The ClinicalTrials.gov listing NCT07410000 names two procedures as interventions: a Quadro Iliac Plane Block and a Sham Block. The trial’s design specifics such as randomization, sample size, and endpoints are not provided in the source text. The objective appears to be evaluating analgesic performance and safety in the postoperative setting after hip replacement. The sponsor is Bursa City Hospital and the site is not indicated beyond the sponsor. The not yet recruiting status signals early stage development and potential future enrollment. Stakeholders should watch the registry for updates on enrollment status protocol amendments and eventual study results that could inform future device or procedural claims.
Safety and regulatory considerations
Analgesia procedures in the pelvic region carry risks such as local tissue irritation nerve irritation infection and hematoma. The QIP Block concept aims to reduce postoperative pain with ultrasound guidance to enhance precision and safety. From a regulatory perspective the entry describes an intention to assess safety and performance in a controlled clinical setting. Claims regarding efficacy or market clearance are not present in the source text and would require robust clinical data and regulatory submission to support any future marketing authorization or device plus procedure claims. MDR Annex XIV style considerations require clear intended purpose performance assessments and safety data when moving from a research protocol to a marketed product or service.
Implications for practice and policy
If subsequent results demonstrate acceptable safety and meaningful analgesia the Quadro Iliac Plane Block could become part of postoperative pain management strategies after hip arthroplasty. Clinicians should await trial results and regulatory updates before integrating the approach into standard care. Regulators will scrutinize trial design endpoints safety data and reporting to determine if any future approvals or claims are warranted. The present report reflects not a proof of efficacy but a description of an investigational study focused on pain management in a specific surgical population.
FAQ
- 1. What is the Quadro Iliac Plane Block? It is described as an ultrasound guided procedure to address postoperative hip pain in the trial described. It is investigational at this stage.
- 2. Who sponsors the study? Bursa City Hospital is listed as the sponsor in the source text.
- 3. What is the registry number? The trial is listed as NCT07410000 on ClinicalTrials.gov.
Conclusion and takeaways
The source text provides a snapshot of an investigational study. The information is not a claim of efficacy or regulatory clearance. Stakeholders should monitor the ClinicalTrials.gov record for updates and consider the MDR Annex XIV framing for future communications.
Disclaimer
This article is for professionals and is not legal advice. It summarizes information from the source text and should not be used as regulatory or clinical guidance. Confirm details with the primary source and applicable regulatory texts.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07410000?term=medical+device