- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06839742
Does Adding Posterior Block to SFIB Increase the Quality of Analgesia in Hip Fractures?
Does the Addition of a Deep Posterior Gluteal Compartment Block to Suprainguinal Fascia Iliaca Block Improve Analgesia in Hip Fracture Surgery? A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ilkadım
-
Samsun, Ilkadım, Turkey (Türkiye)
- Samsun University, Samsun Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the study
- Patients between the ages of 18-90
- ASA I, II, III
- Patients whose surgery duration does not exceed 2 hours
- Patients who will undergo surgery under spinal anesthesia
Exclusion Criteria:
- Patients who do not want to participate in the study/do not give consent
- Patients with a condition that prevents regional anesthesia
- Patients with cognitive dysfunction who are unable to evaluate the NRS score and who cannot use PCA (Patient Controlled Analgesia Device)
- History of hypersensitivity or allergy to local anesthetics
- Patients with psychiatric disorders and those using psychiatric medications
- Presence of hematological disease
- Presence of oncological disease
- Patients with serious major organ failure
- Presence of multiple fractures
- Patients with alcohol or drug addiction
- Patients who have used analgesic drugs up to 12 hours before surgery
- ASA IV-V patients
- Morbidly obese patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group SFICB
Suprainguinal fascia iliaca plane block will be performed 30 minutes before hip surgery
|
Suprainguinal fascia iliaca compartment block will be performed under USG guidance before neuraxial anesthesia.
|
|
Active Comparator: Group Combined
Suprainguinal Fascia İliaca plane Block will be performed 30 minutes before hip surgery and Deep Posterior Gluteal Compartment Block will be performed 20 minutes before hip surgery
|
Suprainguinal fascia iliaca compartment block will be performed under USG guidance before neuraxial anesthesia.
Deep Posterior Gluteal Compartment Block will be performed under USG guidance before neuraxial anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid consumption
Time Frame: 24 hours
|
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of recovery 15 scale
Time Frame: 24 hours after surgery
|
Postoperative Quality of Recovery 15 in Turkish scale
|
24 hours after surgery
|
|
Perioperative pain intensity
Time Frame: 24 hours
|
Changes in the Numerical Rating Scale (NRS) will be recorded at rest and during movement. The participant's baseline NRS will be recorded, followed by measurements before and after neuraxial positioning and up to 24 hours post-surgery. The NRS is a unidimensional measure of pain intensity in adults. It is a segmented numerical version of the Visual Analog Scale (VAS) where the participant selects a whole number (0-10) that best represents the intensity of their pain. The 11-point numerical scale ranges from '0' representing one end of the pain spectrum (e.g. 'no pain') to '10' representing the other end (e.g. 'worst imaginable pain'). |
24 hours
|
|
Quality of patient's position for neuraxial anesthesia
Time Frame: up to ten minutes
|
The position will be evaluated by anesthesiologist and characterized as "unsatisfactory", "satisfactory", "good" or "very good"
|
up to ten minutes
|
|
Quadriceps weakness
Time Frame: 24th hours
|
Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
|
24th hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hatice Selcuk Kusderci, Samsun University
Publications and helpful links
General Publications
- Roche JJ, Wenn RT, Sahota O, Moran CG. Effect of comorbidities and postoperative complications on mortality after hip fracture in elderly people: prospective observational cohort study. BMJ. 2005 Dec 10;331(7529):1374. doi: 10.1136/bmj.38643.663843.55. Epub 2005 Nov 18.
- Safa B, Trinh H, Lansdown A, McHardy PG, Gollish J, Kiss A, Kaustov L, Choi S. Ultrasound-guided suprainguinal fascia iliaca compartment block and early postoperative analgesia after total hip arthroplasty: a randomised controlled trial. Br J Anaesth. 2024 Jul;133(1):146-151. doi: 10.1016/j.bja.2024.04.019. Epub 2024 May 18.
- Vermeylen K, Van Aken D, Versyck B, Casaer S, Bleys R, Bracke P, Groen G. Deep posterior gluteal compartment block for regional anaesthesia of the posterior hip: a proof-of-concept pilot study. BJA Open. 2023 Feb 15;5:100127. doi: 10.1016/j.bjao.2023.100127. eCollection 2023 Mar.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMUKAEAK 2024/276
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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