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

NCT05642975 | Completed

• 1 other identifier: 11.2022.546
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Femur Fracture; Regional Anesthesia

Keywords

Postoperative Pain; Lumbar Erector Spinae Plane Block; Fascia Iliaca Block

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Comparing opioid consumption via Patient Controlled Analgesia (PCA) device

  48 hours

Secondary Outcomes (4)

• Patient Satisfaction

  48 hours

• Complications Related to Pain Management

  48 hours

• Postoperative Pain Scores

  48 hours

• The lengths of ICU and hospital stays

  7 days

Study Arms (3)

Suprainguinal Fascia Iliaca Block

ACTIVE COMPARATOR

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.

Procedure: Regional Block Comparison

Erector Spinae Plane Block

ACTIVE COMPARATOR

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.

Procedure: Regional Block Comparison

Spinal Anesthesia Group (control)

ACTIVE COMPARATOR

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.

Procedure: Regional Block Comparison

Interventions

Regional Block Comparison PROCEDURE

Comparing postoperative pain and opioid consumption in groups

Erector Spinae Plane Block; Spinal Anesthesia Group (control); Suprainguinal Fascia Iliaca Block

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old, undergoing hip fracture surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Femoral Fractures

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: August 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

TU (1)