Clinical trial NCT05862922: Comparison Effects of Two Regional Anesthetic Technique on Pain During High Risk Hip Fracture Surgery
Official title: Comparison Effects of Lumbosacral Plexus Block and Sacral Plexus Block + Suprainguinal Fascia Iliaca Plane Block Combination on Perioperative Pain Measured With Analgesia Nociceptive Index Monitor on High-risk Patients Undergoing Hip Fracture Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Hip Fractures
Perioperative Analgesia
Keywords: analgesia nosiception index
lumbosacral plexus block
suprainguinal fascia iliaca plane block
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asa group of 3-4 patients older than 18 years of age who will undergo hip fracture surgery

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: effective analgesia control in patients with Analgesia Nociception Index (ANI)
timeFrame: postoperative 24 hour
measure: Comparison of the Effects of Two Regional Anesthesia Techniques on Pain in High-Risk Hip Fracture Surgery with analgesia nociception index
timeFrame: postoperative 24 hour
Secondary outcomes:
measure: visual analog scale and ANI consistency comparison
timeFrame: postoperative 24 hour
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
References:
citation: 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.