Retrospective Evaluation of Effect of Anterior Iliac Block | NCT06295224

Studies
Retrospective Evaluation of Effect of Anterior Iliac Block

NCT06295224

Sponsor

Kocaeli University

Status

Completed

Last Update Posted

Mar 6, 2025Actual

Enrollment

16Actual

Phase

Not provided

Conditions

Regional Anesthesia

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Mar 5, 2024Actual

Completion Date

Mar 10, 2024Actual

First Submitted Date

Feb 19, 2024

First Submission Date that Met QC Criteria

Mar 3, 2024

First Posted Date

Mar 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2025

Last Update Posted Date

Mar 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hadi Ufuk Yörükoğlu, principal investigator, Kocaeli UniversityPrincipal Investigator

Lead Sponsor

Kocaeli UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, the investigators aimed to evaluate the effect of ultrasound-guided anterior iliac block which was performed preoperatively. Anterior iliac bone harvesting is associated with severe postoperative pain. As several fascial plane blocks were defined to provide analgesia, their effects are debatable and requires high volumes of local anesthetic considering the regional anesthesia technique used for the main surgical procedure.

Detailed Description

Autologous bone grafting is the method called the gold standard in the reconstruction of bone defects and nonunions. Anterior iliac crest is most frequently preferred as the source of autologous bone graft. However, severe pain after anterior iliac crest graft harvesting increases morbidity. Various regional anesthesia techniques have been defined for the purpose of postoperative analgesia. The mechanism of fascial plane blocks, one of these techniques, has not been fully elucidated and drug distribution varies from person to person. Postoperative analgesia of the iliac crest donor site can be achieved by i infiltration of local anesthetics or morphine. Single injection or continuous infusions of local anesthetic have proven effective in adults.

In this study; the investigators aimed to retrospectively scan the records of patients who received anterior iliac bone graft in our clinic and determine the postoperative analgesia effectiveness of anterior iliac block. The data obtained after the research will make a significant contribution to the literature in the postoperative analgesia management of patients who are planned to receive anterior iliac bone graft.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anterior Iliac Block		Patients who were performed anterior iliac block with ultrasound guidance with 10-20 mL 0.25% bupivacaine.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morphine consumption	Morphine consumption with patient controlled analgesia device	postoperative 1st hour, 6th hour, 12th hour and 24th hour

Secondary Outcomes

Measure	Description	Time Frame
NRS score	NRS score at rest	postoperative 1st hour, 6th hour, 12th hour and 24th hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA-1, ASA-2 and ASA-3 patients
Female/male

Exclusion Criteria:

Anticoagulant drug use
Known allergy to the medications to be used
Infection in the area where the needle will be inserted
Missing data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent anterior iliac graft harvesting and were performed anterior iliac block at Kocaeli University Faculty of Medicine between January 2021 and December 2023 will be included in the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hadi Ufuk Yörükoğlu	Kocaeli University, Department of Anesthesiology and Reanimation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kocaeli Universty		Kocaeli			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17142410	Background	Morgan SJ, Jeray KJ, Saliman LH, Miller HJ, Williams AE, Tanner SL, Smith WR, Broderick JS. Continuous infusion of local anesthetic at iliac crest bone-graft sites for postoperative pain relief. A randomized, double-blind study. J Bone Joint Surg Am. 2006 Dec;88(12):2606-12. doi: 10.2106/JBJS.E.00984.
30886131	Background