Anesthesia MorbidityNCT03318133
Comparison of CLSB With Sedation Versus General Endotracheal Anesthesia on Postoperative Outcomes in Elderly Patients Undergoing Hip Fracture Surgery
A study testing anesthesia in people with Anesthesia Morbidity and Anesthesia; Adverse Effect, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
Hip fracture is a global public health problem. The postoperative mortality and disability rate of hip fracture is high, and early surgery is still the most effective treatment method, but these patients are often associated with concurrent heart and lung and other organ dysfunction, anesthesia and surgery are… Read more about this study
- Who is it for?
- Ages 77 years and older
- Conditions the study is for
- Anesthesia Morbidity, Anesthesia; Adverse Effect
- What is being tested?
- anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,086 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2018to 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 77 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥77 years old;
- First unilateral surgery for hip fracture including femoral neck, intertrochanteric or subtrochanteric fracture;
- Patient with planned hip fracture surgery within 24-72 h;
- Patient without peripheral nerve block within 24 h prior to surgery;
- The ability to receive written informed consent from the patient or patient's legal representative.
Who cannot join
- Refuse to participate;
- Unable to perform nerve block;
- Multiple trauma, multiple fractures or other fractures outside the inclusion criteria, such as pathological fractures, pelvic fractures, femur fractures;
- Prosthetic fracture;
- Scheduled for bilateral hip fracture surgery;
- Usage of bone-cement fixation in the surgery;
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- With recent cerebral stroke (<3 months);
- Combined with active heart disease (unstable angina, acute myocardial infarction, recent myocardial infarction; decompensated heart failure; symptomatic arrhythmia; severe mitral or aortic stenotic heart disease);
- Patient with known severe lung and/or airway disease, acute respiratory failure, acute pulmonary infection, and acute attack of bronchial asthma;
- Current enrolment in another clinical trial;
- Contraindication for general endotracheal anesthesia(drug allergies to general anesthesia, difficult airway);
- Contraindication for lumbar and sacral plexus block(infection at the site of needle insertion, coagulopathy, allergy to local anesthetics).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 021
Xiaofeng XF Wang, MD, +8618930170135, 240483680@qq.com
About this study
Official title: Comparison of Combined Lumbar and Sacral Plexus Block With Sedation Versus General Endotracheal Anesthesia on Postoperative Outcomes in Elderly Patients Undergoing Hip Fracture Surgery(CLSB-HIPELD): Rationale and Design of a Prospective, Multicenter, Randomized Controlled Trial
Hip fracture is a global public health problem. The postoperative mortality and disability rate of hip fracture is high, and early surgery is still the most effective treatment method, but these patients are often associated with concurrent heart and lung and other organ dysfunction, anesthesia and surgery are extremely risky, mainly associated with high incidence of complications in the pulmonary and cardiovascular system, and anesthesia plays a vital role in ensuring that these patients can safely and effectively get through the perioperative period.
The research on the relationship between anesthetic methods and hip fracture surgery prognosis mainly focuses on comparison between neuraxial anesthesia (including spinal anesthesia and epidural anesthesia) and general anesthesia with endotracheal intubation until now. In addition to general anesthesia with endotracheal intubation and neuraxial anesthesia, ultrasound-guided lumbar plexus and sciatic nerve block has been widely used in hip fracture surgery in recent years, especially for some high-risk patients with cardiopulmonary dysfunction. However, it is not clear whether ultrasound-guided combined lumbar plexus and sacral plexus block with sedative anesthesia can improve the prognosis of elderly patients with hip fracture, and in this study, we plan to make a prospective, multicenter, randomized controlled clinical trial to compare the effects of general anesthesia with endotracheal intubation and ultrasound-guided combined lumbar plexus and sacral plexus block with sedative anesthesia on the prognosis of elderly patients with hip fracture to clarify the clinical value of combined lumbar plexus and sacral plexus block with sedative anesthesia in elderly patients with hip fracture.
- Conditions
- Anesthesia Morbidity, Anesthesia; Adverse Effect
- Being tested
- anesthesia
- Keywords
- general anesthesia, sacral plexus block, lumbar plexus block, hip fracture, elderly
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesiaProcedure or surgery
in this study, we plan to make a prospective, multicenter, randomized controlled clinical trial to compare the effects of general anesthesia with endotracheal intubation and ultrasound-guided combined lumbar plexus and sacral plexus block with sedative anesthesia on the prognosis of elderly patients with hip fracture to clarify the clinical value of combined lumbar plexus and sacral plexus block with sedative anesthesia in elderly patients with hip fracture.
| Study group | Role | What they receive |
|---|---|---|
| GA group | Experimental | general anesthesia(GA) group:
1. Open peripheral vein fluid infusion, radial arterial cannulation under local lidocaine anesthesia and arterial blood pressure monitoring
2. Propofol (1.5-3mg/kg), cis-atracurium(0.1-0.15mg/kg) and sulfentanyl(0.2-0.6μg/kg) anesthesia-induced intubation, mechanical ventilation to maintain normal PETCO2
3. Use sevoflurane, propofol and sulfentanyl to maintain anesthesia, and add cis-atracurium as needed
4. Transfer to ICU after surgery Receives: Procedure: anesthesia |
| CLSB group | Experimental | combined lumbar plexus and sacral plexus block(CLSB) group:
1. Open peripheral vein fluid infusion
2. In lateral position (affected side upward), ultrasound-guided lumbar plexus block (0.375% ropivacaine, Lumbar 2-3 or/and 3-4vertebral space level, 25ml), then sacral plexus block (0.375% ropivacaine, 20ml)
3. Radial arterial cannulation under local lidocaine anesthesia and arterial blood pressure monitoring, and blockade effectiveness was evaluated 30min after nerve block
4. After reaching satisfactory blockade, target-controlled infusion of propofol was used to maintain Ramsay sedation score between 5-6 points, monitoring PETCO2 through nasopharyngeal airway, maintain autonomous respiration, and add small-dose fentanyl (10-20μg/time) as needed
5. Transfer to ICU after surgery Receives: Procedure: anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Telephone follow-up will be performed to confirm whether the patient survival or not after surgery.
Measured: month 1
mortality
Telephone follow-up will be performed to confirm whether the patient survival or not after surgery.
Measured: months 3
mortality
Telephone follow-up will be performed to confirm whether the patient survival or not after surgery.
Measured: month 6
mortality
Telephone follow-up will be performed to confirm whether the patient survival or not after surgery.
Measured: month 12
Secondary outcomes (8)
Duration of surgery
The time spent on the surgery will be recorded.
Measured: from the start to the end of the surgery
Intraoperative complications
- Intraoperative hypotension and vasopressor dosage
- Intraoperative arrhythmia, myocardial ischemia, myocardial infarction, massive hemorrhage, pulmonary embolism and hypoxemia
- Intraoperative blood loss and blood transfusion volume
Measured: Intraoperative
Incidence of various complications and comprehensive complication index during hospitalization after surgery
Measured: up to 8 weeks after the surgery
SOFA score(sequential organ failure assessment score)
Sepsis-related organ failure assessment score, also known as sequential organ failure assessment score (SOFA score), is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems.Both the mean and highest SOFA scores are predictors of outcome. An increase in SOFA score during the first 24 to 48 hours in the ICU predicts a mortality rate of at least 50% up to 95%. Scores less than 9 give predictive mortality at 33% while above 11 can be close to or above 95%.
Measured: within 3 days after surgery
Length of stay in ICU and hospital
Measured: up to 8 weeks after the surgery
the Confusion Assessment Method(CAM)
The Confusion Assessment Method includes an instrument and diagnostic algorithm for identification of delirium.The CAM instrument assesses the presence, severity, and fluctuation of 9 delirium features:acute onset, inattention, disorganized thinking, altered level of consciousness, disorientation, memory impairment, perceptual disturbances, psychomotor agitation or retardation, and altered sleep-wake cycle.
Measured: within 3 days after surgery
MMSE(Mini-mental State Examination)
The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating lists of words, arithmetic such as the serial sevens, language use and comprehension, and basic motor skills.
Measured: within 3 days after surgery
High-sensitivity cardiac troponin T(hs-cTnT)
Cardiac troponin is the preferred biomarker for the diagnosis of acute myocardial infarction. A high-sensitivity cardiac troponin T(hs-cTnT) assay permits detection of very low levels of cTnT.
Measured: 1 day before surgery,1 and 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start4 Dec 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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 Anesthesia MorbidityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,086 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofeng WANG, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318133
- Sponsor's protocol ID
- 2016-28(2)
- Status last verified
- Aug 2022
- First submitted
- 15 Oct 2017
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang J, Wang X, Zhang H, Shu Z, Jiang W. Comparison of combined lumbar and sacral plexus block with sedation versus general anaesthesia on postoperative outcomes in elderly patients undergoing hip fracture surgery (CLSB-HIPELD): study protocol for a prospective, multicentre, randomised controlled trial. BMJ Open. 2019 Mar 30;9(3):e022898. doi: 10.1136/bmjopen-2018-022898.
PubMed 30928924
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Combined Lumbar and Sacral Plexus Block With Sedation Versus General Endotracheal Anesthesia on Postoperative Outcomes in Elderly Patients Undergoing Hip Fracture Surgery(CLSB-HIPELD): Rationale and Design of a Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03318133
- Acronym / sponsor ID
- 2016-28(2)
- Conditions
- Anesthesia Morbidity, Anesthesia; Adverse Effect
- Keywords
- general anesthesia, sacral plexus block, lumbar plexus block, hip fracture, elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,086 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Oct 2017 (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 global public health problem. The postoperative mortality and disability rate of hip fracture is high, and early surgery is still the most effective treatment method, but these patients are often associated with concurrent heart and lung and other organ dysfunction, anesthesia and surgery are extremely risky, mainly associated with high incidence of complications in the pulmonary and cardiovascular system, and anesthesia plays a vital role in ensuring that these patients can safely and effectively get through the perioperative period.
The research on the relationship between anesthetic methods and hip fracture surgery prognosis mainly focuses on comparison between neuraxial anesthesia (including spinal anesthesia and epidural anesthesia) and general anesthesia with endotracheal intubation until now. In addition to general anesthesia with endotracheal intubation and neuraxial anesthesia, ultrasound-guided lumbar plexus and sciatic nerve block has been widely used in hip fracture surgery in recent years, especially for some high-risk patients with cardiopulmonary dysfunction. However, it is not clear whether ultrasound-guided combined lumbar plexus and sacral plexus block with sedative anesthesia can improve the prognosis of elderly patients with hip fracture, and in this study, we plan to make a prospective, multicenter, randomized controlled clinical trial to compare the effects of general anesthesia with endotracheal intubation and ultrasound-guided combined lumbar plexus and sacral plexus block with sedative anesthesia on the prognosis of elderly patients with hip fracture to clarify the clinical value of combined lumbar plexus and sacral plexus block with sedative anesthesia in elderly patients with hip fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GA group | Experimental | Procedure: anesthesiageneral anesthesia(GA) group: 1. Open peripheral vein fluid infusion, radial arterial cannulation under local lidocaine anesthesia and arterial blood pressure monitoring 2. Propofol (1.5-3mg/kg), cis-atracurium(0.1-0.15mg/kg) and sulfentanyl(0.2-0.6μg/kg) anesthesia-induced intubation, mechanical ventilation to maintain normal PETCO2 3. Use sevoflurane, propofol and sulfentanyl to maintain anesthesia, and add cis-atracurium as needed 4. Transfer to ICU after surgery |
| CLSB group | Experimental | Procedure: anesthesiacombined lumbar plexus and sacral plexus block(CLSB) group: 1. Open peripheral vein fluid infusion 2. In lateral position (affected side upward), ultrasound-guided lumbar plexus block (0.375% ropivacaine, Lumbar 2-3 or/and 3-4vertebral space level, 25ml), then sacral plexus block (0.375% ropivacaine, 20ml) 3. Radial arterial cannulation under local lidocaine anesthesia and arterial blood pressure monitoring, and blockade effectiveness was evaluated 30min after nerve block 4. After reaching satisfactory blockade, target-controlled infusion of propofol was used to maintain Ramsay sedation score between 5-6 points, monitoring PETCO2 through nasopharyngeal airway, maintain autonomous respiration, and add small-dose fentanyl (10-20μg/time) as needed 5. Transfer to ICU after surgery |
Who may qualify
- Ages
- 77 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥77 years old;
- First unilateral surgery for hip fracture including femoral neck, intertrochanteric or subtrochanteric fracture;
- Patient with planned hip fracture surgery within 24-72 h;
- Patient without peripheral nerve block within 24 h prior to surgery;
- The ability to receive written informed consent from the patient or patient's legal representative.
Key exclusion criteria (12 listed)
- Refuse to participate;
- Unable to perform nerve block;
- Multiple trauma, multiple fractures or other fractures outside the inclusion criteria, such as pathological fractures, pelvic fractures, femur fractures;
- Prosthetic fracture;
- Scheduled for bilateral hip fracture surgery;
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 |
|---|---|---|
| anesthesiain this study, we plan to make a prospective, multicenter, randomized controlled clinical trial to compare the effects of general anesthesia with endotracheal intubation and ultrasound-guided combined lumbar plexus and sacral plexus block with sedative anesthesia on the prognosis of elderly patients with hip fracture to clarify the clinical value of combined lumbar plexus and sacral plexus block with sedative anesthesia in elderly patients with hip fracture. | Procedure or surgery | CLSB group, GA group |
Primary outcome
mortality
Time frame: month 1
Telephone follow-up will be performed to confirm whether the patient survival or not after surgery.
mortality
Time frame: months 3
Telephone follow-up will be performed to confirm whether the patient survival or not after surgery.
mortality
Time frame: month 6
Telephone follow-up will be performed to confirm whether the patient survival or not after surgery.
mortality
Time frame: month 12
Telephone follow-up will be performed to confirm whether the patient survival or not after surgery.
8 secondary outcomes
Duration of surgery
Time frame: from the start to the end of the surgery
Intraoperative complications
Time frame: Intraoperative
Incidence of various complications and comprehensive complication index during hospitalization after surgery
Time frame: up to 8 weeks after the surgery
SOFA score(sequential organ failure assessment score)
Time frame: within 3 days after surgery
Length of stay in ICU and hospital
Time frame: up to 8 weeks after the surgery
the Confusion Assessment Method(CAM)
Time frame: within 3 days after surgery
MMSE(Mini-mental State Examination)
Time frame: within 3 days after surgery
High-sensitivity cardiac troponin T(hs-cTnT)
Time frame: 1 day before surgery,1 and 3 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Derived from this study: PubMed 30928924Zhang J, Wang X, Zhang H, Shu Z, Jiang W. Comparison of combined lumbar and sacral plexus block with sedation versus general anaesthesia on postoperative outcomes in elderly patients undergoing hip fracture surgery (CLSB-HIPELD): study protocol for a prospective, multicentre, randomised controlled trial. BMJ Open. 2019 Mar 30;9(3):e022898. doi: 10.1136/bmjopen-2018-022898.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anesthesia in people with Anesthesia Morbidity and Anesthesia; Adverse Effect, run by Shanghai 6th People's Hospital at 1 site in China.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 26 Aug 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: month 1). The study lists 4 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 NCT03318133, 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 26 Aug 2022.