Comparing Suprainguinal Fascia Iliaca Block With Erector Spinae Plane Block in Hip and Proximal Femur Surgery

August 21, 2024 updated by: Marmara University

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

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey
        • Marmara University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Study Population

Patients over 18 years old, undergoing hip fracture surgery in our university hospital

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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