- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05642975
Comparing Suprainguinal Fascia Iliaca Block With Erector Spinae Plane Block in Hip and Proximal Femur Surgery
Comparing Ultrasound-Guided Suprainguinal Fascia Iliaca Block With Lumbar Erector Spinae Plane Block in Hip and Proximal Femur Fracture Surgery
Most hip fractures occur in the elderly population. Opioid-related respiratory depression is more common in the elderly population but can cause severe brain damage or death. Reducing the amount of opioids administered before, during and after surgery by adding a regional block may increase the postoperative quality of recovery, reduce chronic pain syndromes, and may potentially facilitate the participation of patients in rehabilitation.
Despite their potential advantages, peripheral nerve blocks are still not widely used in people with hip fractures.
The primary objective of this study is to compare patients' postoperative pain scores and opioid consumption.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Marmara University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
- Patients over 18 years old, undergoing hip fracture surgery
Exclusion Criteria:
- Patients with solid organ dysfunction, chronic opioid or corticosteroid use, bleeding diathesis, patients receiving inpatient medication, patients with psychiatric disorders and patients who cannot be contacted after surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Suprainguinal Fascia Iliaca Block
The probe was placed over the inguinal ligament in close proximity to the anterior superior iliac spine and oriented in the parasagittal plane. It was then moved inferomedially along the line of the inguinal ligament to visualize the 'bow-tie' sign. After confirming the needle's position, a total volume of 30 ml of bupivacaine 0.25% was injected. Spinal anesthesia was administered to the patients in a lateral position using 2.5 ml of 0.5% heavy bupivacaine at the L3-L4 level. |
Comparing postoperative pain and opioid consumption in groups
|
|
Active Comparator: Erector Spinae Plane Block
The L5, L4, and L3 transverse processes and erector spinae muscles posteriorly were identified using ultrasound. The curved 6-2 MHz transducer was initially placed at the mid-vertebral line in the sagittal plane and then shifted laterally to visualize the erector spinae muscle and transverse process of the L3 vertebra. A total volume of 40 ml of bupivacaine 0.25% was injected. Spinal anesthesia was administered to the patients in a lateral position using 2.5 ml of 0.5% heavy bupivacaine at the L3-L4 level. |
Comparing postoperative pain and opioid consumption in groups
|
|
Active Comparator: Spinal Anesthesia Group (control)
Spinal anesthesia was administered to the patients in a lateral position using 2.5 ml of 0.5% heavy bupivacaine at the L3-L4 level.
|
Comparing postoperative pain and opioid consumption in groups
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid Consumption
Time Frame: 48 hours
|
Comparing opioid consumption via Patient Controlled Analgesia (PCA) device
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Scores
Time Frame: 48 hours
|
Comparing pain scores with Numeric Rating Scale (NRS)
|
48 hours
|
|
Patient Satisfaction
Time Frame: 48 hours
|
patient satisfaction score: 0: unsatisfied 5: fully satisfied
|
48 hours
|
|
Complications Related to Pain Management
Time Frame: 48 hours
|
complications such as hypothension, nausea, vomiting, itching
|
48 hours
|
|
The lengths of ICU and hospital stays
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11.2022.546
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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