PainNCT05862922
Comparison Effects of Two Regional Anesthetic Technique on Pain During High Risk Hip Fracture Surgery
An observational study of Pain and Hip Fractures, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Hip Fractures, Perioperative Analgesia
- What is being tested?
- Analgesia Nosiception İndex Monitoring
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Nov 2022to 26 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asa group of 3-4 patients older than 18 years of age who will undergo hip fracture surgery
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pain, Hip Fractures, Perioperative Analgesia
- Being tested
- Analgesia Nosiception İndex Monitoring
- Keywords
- analgesia nosiception index, lumbosacral plexus block, suprainguinal fascia iliaca plane block
- Medical subject headings
- Pain, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia Nosiception İndex MonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| lumbosacral plexus block group | Not described Receives: Device: Analgesia Nosiception İndex Monitoring | |
| sacral plexus + suprainguinal fascia iliaca plane block group | Not described Receives: Device: Analgesia Nosiception İndex Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative 24 hour
Comparison of the Effects of Two Regional Anesthesia Techniques on Pain in High-Risk Hip Fracture Surgery with analgesia nociception index
Measured: postoperative 24 hour
Secondary outcomes (1)
visual analog scale and ANI consistency comparison
Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm) Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain. The values can be used to track pain progression for a patient or to compare pain between patients with similar conditions.
Measured: postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start26 Nov 2022
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Recep Aksu, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862922
- Sponsor's protocol ID
- 2022/707
- Status last verified
- Dec 2024
- First submitted
- 3 May 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: If requested by the authorities, IP addresses can be shared.
Publications
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.
PubMed 34623788
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05862922
- Acronym / sponsor ID
- 2022/707
- Conditions
- Pain, Hip Fractures, Perioperative Analgesia
- Keywords
- analgesia nosiception index, lumbosacral plexus block, suprainguinal fascia iliaca plane block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 26 Nov 2022 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lumbosacral plexus block group | – | Device: Analgesia Nosiception İndex Monitoring |
| sacral plexus + suprainguinal fascia iliaca plane block group | – | Device: Analgesia Nosiception İndex Monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asa group of 3-4 patients older than 18 years of age who will undergo hip fracture surgery
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analgesia Nosiception İndex MonitoringANI 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. | Device | lumbosacral plexus block group, sacral plexus + suprainguinal fascia iliaca plane block group |
Primary outcome
effective analgesia control in patients with Analgesia Nociception Index (ANI)
Time frame: postoperative 24 hour
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.
Comparison of the Effects of Two Regional Anesthesia Techniques on Pain in High-Risk Hip Fracture Surgery with analgesia nociception index
Time frame: postoperative 24 hour
1 secondary outcome
visual analog scale and ANI consistency comparison
Time frame: postoperative 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 34623788Neuman 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.
- Individual participant dataSharing planned: Yes. If requested by the authorities, IP addresses can be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Hip Fractures, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effective analgesia control in patients with Analgesia Nociception Index (ANI) (time frame: postoperative 24 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05862922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.