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

• Sponsor: Marmara University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05642975
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

Most hip fractures occur in the elderly population. Opioid-related respiratory depression is more common in the elderly population but can result in severe brain damage or death. Reducing the amount of opioids used 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 alleged advantages, peripheral nerve blocks are still not widely used in people with hip fractures.

The primary implication of this study is to compare patients' postoperative pain scores and opioid consumption.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Femur Fracture; Regional Anesthesia	Procedure: Regional Block Comparison

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comparing Ultrason-Guided Suprainguinal Fascia Iliaca Block With Erector Spinae Plain Block in Hip and Proximal Femur Fracture Surgery
• Actual Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Suprainguinal Fascia Iliaca Block and Spinal Anesthesia Group	Procedure: Regional Block Comparison; Comparing postoperative pain and opioid consumption in groups
Erector Spinae Plain Block and Spinal Anesthesia Group	Procedure: Regional Block Comparison; Comparing postoperative pain and opioid consumption in groups
Spinal Anesthesia Group (control)	Procedure: Regional Block Comparison; Comparing postoperative pain and opioid consumption in groups

Outcome Measures

Primary Outcome Measures

1. Postoperative Pain Scores [48 hours]

   Comparing pain scores with Numeric Rating Scale (NRS)

2. Opioid Consumption [48 hours]

   Comparing opioid consumption via Patient Controlled Analgesia (PCA) device

Secondary Outcome Measures

1. time of mobilisation [7 days]

2. patient satisfaction [48 hours]

3. complications related to pain management [48 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marmara University Hospital	Istanbul		Turkey

Sponsors and Collaborators

• Marmara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marmara University
• ClinicalTrials.gov Identifier: NCT05642975
• Other Study ID Numbers: 11.2022.546
• First Posted: Dec 8, 2022
• Last Update Posted: Dec 8, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marmara University: Postoperative Pain; Lomber Erector Spinae Plane Block; Fascia Iliaca Block
• Additional relevant MeSH terms: Pain, Postoperative; Femoral Fractures

Study Results

No Results Posted as of Dec 8, 2022