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

T

TC Erciyes University

Status

Completed

Conditions

Perioperative Analgesia
Hip Fractures
Pain

Treatments

Device: Analgesia Nosiception İndex Monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT05862922
2022/707

Details and patient eligibility

About

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.

Full description

The most preferred types of anesthesia in hip surgery are general anesthesia or neuraxial blocks. Both types have advantages as well as disadvantages. They may cause hemodynamic instability in geriatric and comorbid patient groups.

Peripheral nerve blocks have been associated with fewer complications both in the treatment of postoperative pain and in fragile, high-risk patients, making them an alternative to other anesthesia types.

It is important for patients to accurately measure their perioperative analgesic needs. There are many subjective methods for assessing pain. In the evaluation of analgesia level with Analgesia Nociception Index (ANI) monitorization, it is advantageous to evaluate the objective findings measuring parasympathetic system activity.

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.

In the high-risk patient group who will undergo hip surgery in the Faculty of Medicine of Erciyes University, the pain sensation in patients will be evaluated using ANI in the perioperative period, after the peripheral nerve blocks have been applied to different anatomical areas that are routinely used.

The aim of this study is to objectively reveal the perioperative pain after peripheral block applications in the patient group with serious additional morbidities by using the ANI device. It is expected that this study will enable more effective analgesia control in patients.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

60 participants in 2 patient groups

lumbosacral plexus block group
Treatment:
Device: Analgesia Nosiception İndex Monitoring
sacral plexus + suprainguinal fascia iliaca plane block group
Treatment:
Device: Analgesia Nosiception İndex Monitoring

Trial contacts and locations

1

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Central trial contact

Rıza Berat OZDOGAN, resident; RECEP AKSU, Professor Doctor

Data sourced from clinicaltrials.gov

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