Comparison Effects of Two Regional Anesthetic Technique on Pain During High Risk Hip Fracture Surgery

NCT05862922 | Completed DMC FDA Device

• 1 other identifier: 2022/707
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, our is to compare effect of lumbosacral plexus and sacral plexus + suprainguinal fascia iliaca plane block on perioperative pain via analgesia nociceptive index monitor on high-risk patients undergoing hip fracture surgery.

Conditions

Pain; Hip Fractures; Perioperative Analgesia

Keywords

analgesia nosiception index; lumbosacral plexus block; suprainguinal fascia iliaca plane block

Outcome Measures

Primary Outcomes (2)

• effective analgesia control in patients with Analgesia Nociception Index (ANI)

  With Analgesia Nociception Index (ANI), it is advantageous to evaluate the objective findings measuring parasympathetic system activity. A value between 0-100 is obtained, Values between 50 and 70 indicate good analgesia control. According to studies on ANI, the patient feels pain below 50. If it is above 70, it means that more analgesia is provided. It is thought that pain control will be more effective with these objective data.

  postoperative 24 hour

• Comparison of the Effects of Two Regional Anesthesia Techniques on Pain in High-Risk Hip Fracture Surgery with analgesia nociception index

  postoperative 24 hour

Secondary Outcomes (1)

• visual analog scale and ANI consistency comparison

  postoperative 24 hour

Study Arms (2)

lumbosacral plexus block group

Device: Analgesia Nosiception İndex Monitoring

sacral plexus + suprainguinal fascia iliaca plane block group

Device: Analgesia Nosiception İndex Monitoring

Interventions

Analgesia Nosiception İndex Monitoring DEVICE

ANI is a monitor that can be measured continuously and non-invasively. It measures parasympathetic tone - based on electrocardiography - by analyzing minimal changes in heart rate that occur under anesthesia, in the early stages of awakening, and in each respiratory cycle of awake patients. At the end of the measurement, a value between 0-100 is obtained. Parasympathetic modulation (stress level, e.g., pain) is obtained with a minimum value of 0 and a maximum of 100. ANI values measured in the early period of recovery correlate with pain scores. When compared with hemodynamic parameters, it has been reported that the ANI response is more sensitive to nociceptive stimuli occurring in the intraoperative period.

lumbosacral plexus block group; sacral plexus + suprainguinal fascia iliaca plane block group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Asa group of 3-4 patients older than 18 years of age who will undergo hip fracture surgery

You may qualify if:

• Patients over the age of 18 who will undergo hip surgery
• ASA group 3-4 patients
• Patients without allergies
• Patients without psychiatric disorders
• Patients without opioid dependence
• Patients without severe liver and kidney failure
• Patients without arrhythmia and beta-blocker use
• Patients without contraindications for peripheral blocks

You may not qualify if:

• Patients who do not accept peripheral nerve block
• Patients with failed peripheral nerve block
• Patients scheduled for bilateral hip fracture surgery
• Patients who have been operated on for hip fractures before
• Patients with arrhythmia and beta-blocker use
• Patients with contraindications for peripheral blocks
• Chronic opioid consumption

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Turkey (Türkiye)

Location

Related Publications (1)

• Neuman MD, Feng R, Carson JL, Gaskins LJ, Dillane D, Sessler DI, Sieber F, Magaziner J, Marcantonio ER, Mehta S, Menio D, Ayad S, Stone T, Papp S, Schwenk ES, Elkassabany N, Marshall M, Jaffe JD, Luke C, Sharma B, Azim S, Hymes RA, Chin KJ, Sheppard R, Perlman B, Sappenfield J, Hauck E, Hoeft MA, Giska M, Ranganath Y, Tedore T, Choi S, Li J, Kwofie MK, Nader A, Sanders RD, Allen BFS, Vlassakov K, Kates S, Fleisher LA, Dattilo J, Tierney A, Stephens-Shields AJ, Ellenberg SS; REGAIN Investigators. Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults. N Engl J Med. 2021 Nov 25;385(22):2025-2035. doi: 10.1056/NEJMoa2113514. Epub 2021 Oct 9.

  PMID: 34623788 BACKGROUND

MeSH Terms

Conditions

Pain; Hip Fractures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 17, 2023
• Study Start: November 26, 2022
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available within 12 months of study completion
• Access Criteria: Data accept requests will be reviewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement.

Locations

TU (1)