Postoperative Cognitive ComplicationsNCT06963229
Spinal Anesthesia Vs. Neve Block in Risk of Cognitive Decline
A study testing Spinal Anesthesia (bupivacaine) and Peripheral Nerve Block in people with Postoperative Cognitive Complications, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Hip fracture is a potentially devastating event, and serious surgical and medical complications occur frequently especially for elderly patients. Delirium is one of the common complications after hip surgery. This study objective is to assess the association between type of anesthesia (nerve block vs. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Complications
- What is being tested?
- Spinal Anesthesia (bupivacaine) and Peripheral Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteLebanon
- Study dates
- 21 Apr 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Admitted with a hip fracture (femoral neck, trochanteric or sub-trochanteric)
- 65 years or older
- 40 Kgs in weight and higher
Who cannot join
- Uncooperative
- Considered as moribund by the orthopedic surgeon at admission
- Alzheimer
- Severe cognitive impairment (MMSE<18)
- Absolute contraindication for spinal anesthesia (assessed preoperatively)
- Allergy to local anesthesia
- Have any severe visual disorder or debilitating vascular event
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Changes After Hip Prosthesis; Comparison Between Combined Lumbosacral Nerve Block Versus Spinal Anesthesia: A Double Blind Randomized Clinical Trial
Hip fracture is a potentially devastating event, and serious surgical and medical complications occur frequently especially for elderly patients. Delirium is one of the common complications after hip surgery.
This study objective is to assess the association between type of anesthesia (nerve block vs. spinal anesthesia) and risk of cognitive decline (CD). And its secondary objective is to compare intra-operative hemodynamic changes, and post-operative pain.
Prospective, double blind randomized clinical trial of hip fracture patients who will be assessed for CD pre- and postoperatively, for three months after surgery. Patients undergoing hip surgery will be randomized into two groups. Group 1 will receive unilateral lumbosacral nerve block (sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5) as well as placebo injection (1 ml normal saline) at the spinal anesthesia level (L3-L4 or L4-L5). Group 2 will receive spinal anesthesia in addition to placebo injection at the sciatic, L3-L4 and L4-L5 levels.
Read the detailed description
Hip fracture is a potentially devastating event, and serious surgical and medical complications occur frequently especially for elderly patients. Around one-third of the patients pass away within the first post-operative year.
One of the most common complications in hip fracture patients is delirium which is characterized by an acute disturbance in awareness, attention and cognitive function. Delirium has a fluctuating course and is usually reversible. However, evidence suggests an association between delirium and future cognitive decline and development of dementia during months after the delirium episode. Dementia is a chronic syndrome characterized by cognitive decline, impairment in activities of daily living and a change in social abilities and behavior.
Several risk factors are identified for preoperative and postoperative delirium including age, comorbidities, intraoperative hypotension and use of vasopressors. There is some controversy about the cognitive consequences due to the type of anesthesia used.
Spinal and general anesthesia are commonly used for hip surgery. An alternative technique is the combined sciatic-paravertebral block that has been used to overcome the adverse effects associated with spinal and general anesthesia. This anesthetic technique was associated with less intraoperative hypotension and reduced rate of ICU admission. Given the promising effect of paravertebral block on the outcome of hip surgery, we will conduct this study to assess the effect of paravertebral block on postoperative CD.
- Conditions
- Postoperative Cognitive Complications
- Being tested
- Spinal Anesthesia (bupivacaine), Peripheral Nerve Block
- Keywords
- Fractures, Hip, Nerve Block, Spinal Anesthesia, Nerve, Sciatic, paravertebral, Aged
- Medical subject headings
- Postoperative Cognitive Complications, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Anesthesia (bupivacaine)Procedure or surgery
L3-L4 or L4-L5 3cc of 2% bupivacaine
Peripheral Nerve BlockProcedure or surgery
Sciatic Nerve Block 20ml of Anesthetic Mixture, Paravertebral Nerve Block (L3-L4 and L4-L5) 20ml of Anesthetic Mixture
Mixture Details:
- 5ml Lidocaine 2%
- 5ml Lidocaine 1% with Adrenaline (1-200000)
- 10ml Bupivacaine 0.5%
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anesthesia | Active comparator | Not described Receives: Procedure: Spinal Anesthesia (bupivacaine) |
| Lumbosacral Nerve Block | Active comparator | Not described Receives: Procedure: Peripheral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Cognitive Decline Post-operatively
A questionnaire will be used to collect data. Demographic information including age (by year), gender, ASA score (I-IV), BMI (kg/m^2), clinical condition pre-fracture (MMSE Score), as well as type and duration (by days) of fracture will be collected. The patient's cognitive function will be assessed before the operation using the MMSE. The MMSE is a validated questionnaire that is comprised of six sections examining the following functions: orientation, registration, attention and calculation, recall, language, as well as ability to follow simple commands and orientation.
Illiterate patients will not be asked the questions pertaining to attention and calculation in addition to language questions. Hence, for these patients the score will be over 23 but it will be converted to a score over 30.
Total Score is 30; a score between 24 and 30 indicates no cognitive impairment, a score between 18 and 23 means mild cognitive impairment and a score between 0 and17 indicates severe impairment
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start21 Apr 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive ComplicationsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Rajab, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963229
- Sponsor's protocol ID
- MGH-07-24002
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naja Z, el Hassan MJ, Khatib H, Ziade MF, Lonnqvist PA. Combined sciatic-paravertebral nerve block vs. general anaesthesia for fractured hip of the elderly. Middle East J Anaesthesiol. 2000 Jun;15(5):559-68.
PubMed 11126507Zywiel MG, Prabhu A, Perruccio AV, Gandhi R. The influence of anesthesia and pain management on cognitive dysfunction after joint arthroplasty: a systematic review. Clin Orthop Relat Res. 2014 May;472(5):1453-66. doi: 10.1007/s11999-013-3363-2.
PubMed 24186470Davis N, Lee M, Lin AY, Lynch L, Monteleone M, Falzon L, Ispahany N, Lei S. Postoperative cognitive function following general versus regional anesthesia: a systematic review. J Neurosurg Anesthesiol. 2014 Oct;26(4):369-76. doi: 10.1097/ANA.0000000000000120.
PubMed 25144505Tzimas P, Samara E, Petrou A, Korompilias A, Chalkias A, Papadopoulos G. The influence of anesthetic techniques on postoperative cognitive function in elderly patients undergoing hip fracture surgery: General vs spinal anesthesia. Injury. 2018 Dec;49(12):2221-2226. doi: 10.1016/j.injury.2018.09.023. Epub 2018 Sep 11.
PubMed 30526923Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.
PubMed 22762316Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013.
PubMed 20664045Bickel H, Gradinger R, Kochs E, Forstl H. High risk of cognitive and functional decline after postoperative delirium. A three-year prospective study. Dement Geriatr Cogn Disord. 2008;26(1):26-31. doi: 10.1159/000140804. Epub 2008 Jun 24.
PubMed 18577850Abrahamsen B, van Staa T, Ariely R, Olson M, Cooper C. Excess mortality following hip fracture: a systematic epidemiological review. Osteoporos Int. 2009 Oct;20(10):1633-50. doi: 10.1007/s00198-009-0920-3. Epub 2009 May 7.
PubMed 19421703
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Changes After Hip Prosthesis; Comparison Between Combined Lumbosacral Nerve Block Versus Spinal Anesthesia: A Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06963229
- Acronym / sponsor ID
- MGH-07-24002
- Conditions
- Postoperative Cognitive Complications
- Keywords
- Fractures, Hip, Nerve Block, Spinal Anesthesia, Nerve, Sciatic, paravertebral, Aged
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 8 May 2025 (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.
Hip fracture is a potentially devastating event, and serious surgical and medical complications occur frequently especially for elderly patients. Delirium is one of the common complications after hip surgery.
This study objective is to assess the association between type of anesthesia (nerve block vs. spinal anesthesia) and risk of cognitive decline (CD). And its secondary objective is to compare intra-operative hemodynamic changes, and post-operative pain.
Prospective, double blind randomized clinical trial of hip fracture patients who will be assessed for CD pre- and postoperatively, for three months after surgery. Patients undergoing hip surgery will be randomized into two groups. Group 1 will receive unilateral lumbosacral nerve block (sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5) as well as placebo injection (1 ml normal saline) at the spinal anesthesia level (L3-L4 or L4-L5). Group 2 will receive spinal anesthesia in addition to placebo injection at the sciatic, L3-L4 and L4-L5 levels.
Detailed description
Hip fracture is a potentially devastating event, and serious surgical and medical complications occur frequently especially for elderly patients. Around one-third of the patients pass away within the first post-operative year.
One of the most common complications in hip fracture patients is delirium which is characterized by an acute disturbance in awareness, attention and cognitive function. Delirium has a fluctuating course and is usually reversible. However, evidence suggests an association between delirium and future cognitive decline and development of dementia during months after the delirium episode. Dementia is a chronic syndrome characterized by cognitive decline, impairment in activities of daily living and a change in social abilities and behavior.
Several risk factors are identified for preoperative and postoperative delirium including age, comorbidities, intraoperative hypotension and use of vasopressors. There is some controversy about the cognitive consequences due to the type of anesthesia used.
Spinal and general anesthesia are commonly used for hip surgery. An alternative technique is the combined sciatic-paravertebral block that has been used to overcome the adverse effects associated with spinal and general anesthesia. This anesthetic technique was associated with less intraoperative hypotension and reduced rate of ICU admission. Given the promising effect of paravertebral block on the outcome of hip surgery, we will conduct this study to assess the effect of paravertebral block on postoperative CD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia | Active comparator | Procedure: Spinal Anesthesia (bupivacaine) |
| Lumbosacral Nerve Block | Active comparator | Procedure: Peripheral Nerve Block |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Admitted with a hip fracture (femoral neck, trochanteric or sub-trochanteric)
- 65 years or older
- 40 Kgs in weight and higher
Key exclusion criteria (7 listed)
- Uncooperative
- Considered as moribund by the orthopedic surgeon at admission
- Alzheimer
- Severe cognitive impairment (MMSE<18)
- Absolute contraindication for spinal anesthesia (assessed preoperatively)
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 |
|---|---|---|
| Spinal Anesthesia (bupivacaine)L3-L4 or L4-L5 3cc of 2% bupivacaine | Procedure or surgery | Spinal Anesthesia |
| Peripheral Nerve BlockSciatic Nerve Block 20ml of Anesthetic Mixture, Paravertebral Nerve Block (L3-L4 and L4-L5) 20ml of Anesthetic Mixture Mixture Details: * 5ml Lidocaine 2% * 5ml Lidocaine 1% with Adrenaline (1-200000) * 10ml Bupivacaine 0.5% | Procedure or surgery | Lumbosacral Nerve Block |
Primary outcome
Assessment of Cognitive Decline Post-operatively
Time frame: 3 Months
A questionnaire will be used to collect data. Demographic information including age (by year), gender, ASA score (I-IV), BMI (kg/m^2), clinical condition pre-fracture (MMSE Score), as well as type and duration (by days) of fracture will be collected. The patient's cognitive function will be assessed before the operation using the MMSE. The MMSE is a validated questionnaire that is comprised of six sections examining the following functions: orientation, registration, attention and calculation, recall, language, as well as ability to follow simple commands and orientation. Illiterate patients will not be asked the questions pertaining to attention and calculation in addition to language questions. Hence, for these patients the score will be over 23 but it will be converted to a score over 30. Total Score is 30; a score between 24 and 30 indicates no cognitive impairment, a score between 18 and 23 means mild cognitive impairment and a score between 0 and17 indicates severe impairment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Results publication: PubMed 11126507Naja Z, el Hassan MJ, Khatib H, Ziade MF, Lonnqvist PA. Combined sciatic-paravertebral nerve block vs. general anaesthesia for fractured hip of the elderly. Middle East J Anaesthesiol. 2000 Jun;15(5):559-68.
- Results publication: PubMed 24186470Zywiel MG, Prabhu A, Perruccio AV, Gandhi R. The influence of anesthesia and pain management on cognitive dysfunction after joint arthroplasty: a systematic review. Clin Orthop Relat Res. 2014 May;472(5):1453-66. doi: 10.1007/s11999-013-3363-2.
- Results publication: PubMed 25144505Davis N, Lee M, Lin AY, Lynch L, Monteleone M, Falzon L, Ispahany N, Lei S. Postoperative cognitive function following general versus regional anesthesia: a systematic review. J Neurosurg Anesthesiol. 2014 Oct;26(4):369-76. doi: 10.1097/ANA.0000000000000120.
- Results publication: PubMed 30526923Tzimas P, Samara E, Petrou A, Korompilias A, Chalkias A, Papadopoulos G. The influence of anesthetic techniques on postoperative cognitive function in elderly patients undergoing hip fracture surgery: General vs spinal anesthesia. Injury. 2018 Dec;49(12):2221-2226. doi: 10.1016/j.injury.2018.09.023. Epub 2018 Sep 11.
- Results publication: PubMed 22762316Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.
- Results publication: PubMed 20664045Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013.
- Results publication: PubMed 18577850Bickel H, Gradinger R, Kochs E, Forstl H. High risk of cognitive and functional decline after postoperative delirium. A three-year prospective study. Dement Geriatr Cogn Disord. 2008;26(1):26-31. doi: 10.1159/000140804. Epub 2008 Jun 24.
- Results publication: PubMed 19421703Abrahamsen B, van Staa T, Ariely R, Olson M, Cooper C. Excess mortality following hip fracture: a systematic epidemiological review. Osteoporos Int. 2009 Oct;20(10):1633-50. doi: 10.1007/s00198-009-0920-3. Epub 2009 May 7.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Spinal Anesthesia (bupivacaine) and Peripheral Nerve Block in people with Postoperative Cognitive Complications, run by Makassed General Hospital at 1 site in Lebanon.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. 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 Lebanon. 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?
This study is still under way. Results are not available in the source record yet.
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?
Assessment of Cognitive Decline Post-operatively (time frame: 3 Months). 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 NCT06963229, which also lists 8 linked publications.
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 14 May 2025.