Delirium in Old AgeNCT05819723
Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries
A study testing CAM score in people with Delirium in Old Age, run by Ain Shams University at 1 site in Egypt.
Trial summary
Postoperative pain is a significant risk factor for delirium. This clinical trial will search whether analgesia produced by erector spinae block in elderly patients undergoing hip fracture surgeries reduces delirium or not! Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Delirium in Old Age
- What is being tested?
- CAM score
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 31 Dec 2023
- Phase
- Interventional
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >60 years.
- American Society of Anesthesiologists physical status I, II.
- Patients undergoing hip fracture surgeries under spinal anaesthesia
- Exclusion Criteria: • History of neurological or psychiatric disease.
- Allergy to local anaesthetics.
- Infection in the injection area.
Show all 11Show fewer
- Regular medication with tranquillizers and/or antidepressants.
- CAM scores II-VI.
- Delayed fracture surgeries more than 48 hours.
- Intraoperative blood loss of more than 1000 ml.
- Patient refusal.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesia Produced by Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries
Postoperative pain is a significant risk factor for delirium. This clinical trial will search whether analgesia produced by erector spinae block in elderly patients undergoing hip fracture surgeries reduces delirium or not!
Read the detailed description
This randomized controlled trial will include 120 elderly patients American Society of Anesthesiologists physical status I-II, aged more than 60 years old and undergoing fracture hip surgeries.
all patients will be examined for preoperative cognitive impairment using the short form of the Confusion Assessment Method Survey (CAM) and the long form will be used postoperatively.
The CAM scores is an algorithm that consists of four features:
(i) Acute and fluctuating variation in mental status, (ii) Inattention, (iii) Incoherent or disorganized thinking, and (iv) Altered level of consciousness.CAM scores indicate delirium if the first two features are present and either the third or fourth feature is present.
Patients with a delirium of CAM score>1 will be excluded from the study. also, patients will be asked to rate their baseline pain levels using the numeric rating scales (NRS) from "no pain" to "worst possible pain". patients will be randomly divided into two equal groups Group 1: spinal anaesthesia only. Group 2: spinal anaesthesia with erector spinae block. In both groups, basic monitoring in the form of non-invasive blood pressure (NIBP), pulse oxygen saturation (SPO2)and 5-lead electrocardiogram (ECG) will be attached in the operating room(OR)
The spinal anaesthesia will be done in both groups under a complete aseptic technique induced using 3ml bupivacaine 0.5% with 25μg fentanyl.
At the end of the operation patients in group 2 will receive the block at the lateral position.
The transverse process of the 4th lumbar vertebra will be identified 4-6 cm laterally to the midline. An echogenic needle will be inserted using the out-of-plane technique until it touches the transverse process. Following negative aspiration, 20 ml of 0.25% bupivacaine will be injected.
patients will be monitored in the PACU for at least one hour by NIBP, SPO2, and ECG and any abnormality will be recorded and managed accordingly.
The cognitive functions will be re-evaluated one hour after the recovery from the surgery in PACU using the CAM scores. and on the first and the second days postoperatively using CAM score for occurrence and severity of cognitive dysfunction if present. Then every symptom will be rated and listed in the CAM-S as absent (0, mild (1), or severe (2), where higher scores indicate more severe delirium and patients with POD will be followed up and managed properly by neurologists. Patients in the two groups will be compared regarding the incidence and severity of delirium on the first and second postoperative days.
- Conditions
- Delirium in Old Age
- Being tested
- CAM score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAM scoreOther
The CAM scores assess the presence of delirium rapidly and accurately and also differentiates delirium from other cognitive impairment with a sensitivity of 94-100% and specificity of 90-95%.
It is an algorithm that consists of four features:
(i) Acute and fluctuating variation in mental status, (ii) Inattention, (iii) Incoherent or disorganized thinking, and (iv) Altered level of consciousness. CAM scores indicate delirium if the first two features are present and either the third or fourth feature is present.
| Study group | Role | What they receive |
|---|---|---|
| spinal anesthesia only | Active comparator | The spinal anaesthesia will be done under a complete aseptic technique induced using 3ml bupivacaine 0.5% with 25μg fentanyl Receives: Other: CAM score |
| spinal anesthesia with erector spinae block | Active comparator | The spinal anaesthesia will be done under a complete aseptic technique induced using 3ml bupivacaine 0.5% with 25μg fentanyl, then erector spinae block will be given The transverse process of the 4th lumbar vertebra will be identified 4-6 cm laterally to the midline. An echogenic needle will be inserted using the out-of-plane technique until it touches the transverse process. Following negative aspira¬tion, 20 ml of 0.25% bupivacaine will be injected Receives: Other: CAM score |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative delirium
occurrence and severity of cognitive dysfunction
Measured: first days postoperative
Secondary outcomes (1)
complications from erector spinae block
block failure, haematoma
Measured: on the first and the second days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 May 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Maher Hussien, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819723
- Sponsor's protocol ID
- FMASU MS 99/2023
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia Produced by Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries
- ClinicalTrials.gov ID
- NCT05819723
- Acronym / sponsor ID
- FMASU MS 99/2023
- Conditions
- Delirium in Old Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Apr 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.
Postoperative pain is a significant risk factor for delirium. This clinical trial will search whether analgesia produced by erector spinae block in elderly patients undergoing hip fracture surgeries reduces delirium or not!
Detailed description
This randomized controlled trial will include 120 elderly patients American Society of Anesthesiologists physical status I-II, aged more than 60 years old and undergoing fracture hip surgeries.
all patients will be examined for preoperative cognitive impairment using the short form of the Confusion Assessment Method Survey (CAM) and the long form will be used postoperatively.
The CAM scores is an algorithm that consists of four features:
(i) Acute and fluctuating variation in mental status, (ii) Inattention, (iii) Incoherent or disorganized thinking, and (iv) Altered level of consciousness.CAM scores indicate delirium if the first two features are present and either the third or fourth feature is present.
Patients with a delirium of CAM score>1 will be excluded from the study. also, patients will be asked to rate their baseline pain levels using the numeric rating scales (NRS) from "no pain" to "worst possible pain". patients will be randomly divided into two equal groups Group 1: spinal anaesthesia only. Group 2: spinal anaesthesia with erector spinae block. In both groups, basic monitoring in the form of non-invasive blood pressure (NIBP), pulse oxygen saturation (SPO2)and 5-lead electrocardiogram (ECG) will be attached in the operating room(OR)
The spinal anaesthesia will be done in both groups under a complete aseptic technique induced using 3ml bupivacaine 0.5% with 25μg fentanyl.
At the end of the operation patients in group 2 will receive the block at the lateral position.
The transverse process of the 4th lumbar vertebra will be identified 4-6 cm laterally to the midline. An echogenic needle will be inserted using the out-of-plane technique until it touches the transverse process. Following negative aspiration, 20 ml of 0.25% bupivacaine will be injected.
patients will be monitored in the PACU for at least one hour by NIBP, SPO2, and ECG and any abnormality will be recorded and managed accordingly.
The cognitive functions will be re-evaluated one hour after the recovery from the surgery in PACU using the CAM scores. and on the first and the second days postoperatively using CAM score for occurrence and severity of cognitive dysfunction if present. Then every symptom will be rated and listed in the CAM-S as absent (0, mild (1), or severe (2), where higher scores indicate more severe delirium and patients with POD will be followed up and managed properly by neurologists. Patients in the two groups will be compared regarding the incidence and severity of delirium on the first and second postoperative days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal anesthesia only | Active comparator | Other: CAM scoreThe spinal anaesthesia will be done under a complete aseptic technique induced using 3ml bupivacaine 0.5% with 25μg fentanyl |
| spinal anesthesia with erector spinae block | Active comparator | Other: CAM scoreThe spinal anaesthesia will be done under a complete aseptic technique induced using 3ml bupivacaine 0.5% with 25μg fentanyl, then erector spinae block will be given The transverse process of the 4th lumbar vertebra will be identified 4-6 cm laterally to the midline. An echogenic needle will be inserted using the out-of-plane technique until it touches the transverse process. Following negative aspira¬tion, 20 ml of 0.25% bupivacaine will be injected |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age >60 years.
- American Society of Anesthesiologists physical status I, II.
- Patients undergoing hip fracture surgeries under spinal anaesthesia
- Exclusion Criteria: • History of neurological or psychiatric disease.
- Allergy to local anaesthetics.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CAM scoreThe CAM scores assess the presence of delirium rapidly and accurately and also differentiates delirium from other cognitive impairment with a sensitivity of 94-100% and specificity of 90-95%. It is an algorithm that consists of four features: (i) Acute and fluctuating variation in mental status, (ii) Inattention, (iii) Incoherent or disorganized thinking, and (iv) Altered level of consciousness. CAM scores indicate delirium if the first two features are present and either the third or fourth feature is present. | Other | spinal anesthesia only, spinal anesthesia with erector spinae block |
Primary outcome
post operative delirium
Time frame: first days postoperative
occurrence and severity of cognitive dysfunction
1 secondary outcome
complications from erector spinae block
Time frame: on the first and the second days postoperative
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 9 Oct 2024.
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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?
A study testing CAM score in people with Delirium in Old Age, run by Ain Shams University at 1 site in Egypt.
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 11 inclusion and 0 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 9 Oct 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 Egypt. 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?
post operative delirium (time frame: first days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2024.