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Elderly (People Aged 65 or More)PASPOPNCT06696404

The Role of Precision Anesthesia Strategy on Perioperative Organ Protection in Hip Surgery [PASPOP]

A study testing Combined Lumbar Plexus and Sacral Plexus Block, iliac fascial block and spinal anesthesia in people with Elderly (People Aged 65 or More) and Hip Fracture, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to investigate the effect of three anesthetic strategies on organ protection in elderly patients undergoing hip fracture surgery. The main questions it aims to answer are: 1.Does the nerve block anesthesia group have a protective effect on the incidence of postoperative delirium in… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Combined Lumbar Plexus and Sacral Plexus Block, iliac fascial block and spinal anesthesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesChina
Study dates
1 Dec 2024to 5 Apr 2025
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Aged 65 years and older
  • American Society of Anesthesiologists (ASA) physical status 1 to 3
  • Scheduled for unilateral hip surgery

Who cannot join

  • Have psychiatric disorders or cognitive impairments, or are unable to understand the scale
  • Have a heart failure history (EF < 40) or a history of AMI in 3 months
  • Complex injuries: multiple fractures, chest, abdomen, pelvic and sacral trauma, head trauma, etc.
  • Combined with respiratory failure or hepatic failure (Child-Pugh C) or renal failure (rely on dialysis treatment)
  • Nerve block contraindication: puncture site infection, peripheral neuropathy, regional anesthetic allergy, etc.
  • Contraindications of intraspinal anesthesia: coagulation dysfunction, thrombocytopenia, intraspinal space occupying, infection of puncture site, etc.
  • Relative contraindications of general anesthesia: known difficult airway, malignant hyperthermia, etc.
  • Enrolled in another randomized clinical trial

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Arm Medical Center of PLA

    Chongqing, Chongqing Municipality, 400042

  • Shanghai 6th People's hospital

    Shanghai, Shanghai Municipality, 200233

Other trials in China

About this study

Official title: The Role of Nerve Block-Constructed Precision Anesthesia on Perioperative Organ Protection in Hip Surgery

The goal of this clinical trial is to investigate the effect of three anesthetic strategies on organ protection in elderly patients undergoing hip fracture surgery.

The main questions it aims to answer are: 1.Does the nerve block anesthesia group have a protective effect on the incidence of postoperative delirium in elderly patients undergoing hip surgery? 2.Does the nerve block anesthesia group also provide protective effects on other organs for elderly patients undergoing hip surgery? 3.What effects will these anesthetic strategies have on short-term and long-term prognosis of elderly patients undergoing hip surgery?

Read more

The investigators will compare it with the spinal anesthesia group and the general anesthesia group to see which has a better protective effect on organs.

Participants will undergo preoperative interviews and will be interviewed twice daily, in the morning and evening, from postoperative day 1 to 7 or until discharge, to assess the occurrence of delirium and cognitive levels, pain intensity, and sleep status.

Interventions:

  1. Nerve block anesthesia group (NA group): Combined Lumbar and Sacral Plexus Block + sedation or laryngeal mask anesthesia
  2. General anesthesia group (GA group): General anesthesia (Endotracheal intubation) + iliac fascial block
  3. Spinal anesthesia group (SA group): Spinal anesthesia without any nerve blockade
Read the detailed description

Background: Over 10 million hip fractures happen per year globally, which lead to a burden on patients, their families, and healthcare systems.98% hip fracture patients require orthopedic surgery. Hip fracture patients are typically elderly and often have multiple comorbidities, decreased organ function, poor physical tolerance, high anesthesia risks, and slow postoperative recovery. Perioperative blood loss is considerable during hip surgery, and the stress response is significant, often leading to severe postoperative pain, which can result in organ damage and complications. These patients pose challenges to anesthesia management, but at the same time, making the anesthetic care episode a major opportunity to impact outcomes.In clinical practice, general anesthesia and spinal anesthesia are the two most commonly used anesthesia strategies. However, current domestic and international studies believe that there is no difference in outcomes for patients undergoing hip surgery under these two strategies. With the advancement of medical science, nerve blocks, due to precise action on the surgical area and effective suppression of postoperative pain, are increasingly applied in clinical settings. When combined with light general anesthesia, nerve blocks can meet surgical requirements. Nerve blocks can reduce quadriceps spasms, decrease stress responses, help maintain hemodynamic stability, and thus might have potential organ-protective effects. Due to the inconsistent clinical research outcomes regarding nerve blocks, coupled with a lack of high-quality study results, the investigators plan to conduct this study to explore the anesthetic strategy with the most prognostic improvement value for patients undergoing hip surgery. So, it will fill critical evidence gaps to inform policy and practice.

Purpose: The purpose of this study is to explore, in the real world, which anesthesia strategy has more organ-protective effects and accelerates postoperative recovery for patients undergoing hip surgery.

Research Design: A prospective randomized three-arm parallel-group double-center exploratory trial with blinded end point evaluation.

Primary hypothesis is that participantis who receive combined lumbar plexus and sacral plexus block + sedation or laryngeal mask anaesthesia will demonstrate improved recovery after randomisation compared with participants who receive general anaesthesia or spinal anesthesia.

Research population: Elderly patients with acute hip fractures requiring surgical treatment.

Interventions:

Participants randomly assigned to NA or GA or SA group in a 1:1:1 ratio.

  1. Nerve block anesthesia group (NA group): Combined Lumbar Plexus and Sacral Plexus Block + sedation or laryngeal mask anesthesia. Participants assigned to the NA group will receive lumbar-sacral plexus block combined with laryngeal mask anesthesia. The lumbar-sacral plexus block (0.33% ropivacaine 30ml+20ml) will be performed under the guidance of an ultrasound or nerve stimulator, and the effectiveness of the block will be assessed 20 minutes after the nerve block. Subsequently, participants will undergo sedation or laryngeal mask anesthesia.
  2. General anesthesia group (GA group): General anesthesia + iliac fascial block .Participants assigned to the GA group will receive iliac fascial block combined with endotracheal intubation general anesthesia. The iliac fascial block (0.33% ropivacaine 30ml) will be performed under the guidance of an ultrasound or nerve stimulator, and the effectiveness of the block will be assessed 20 minutes after the nerve block. Subsequently, participants will undergo endotracheal intubation general anesthesia.
  3. Spinal anesthesia group (SA group):Spinal anesthesia without any nerve blockade. Participants assigned to the SA group will receive spinal anesthesia with or without sedation. Spinal anesthesia is The spinal puncture site is at L2-3 or L3-4. After the puncture needle reaches the subarachnoid space, 1% ropivacaine 0.8-2 ml, totaling 8-20mg, is injected. Depending on the center's practice, it may be replaced with an equivalent dose of bupivacaine .

Statistical analysis:

This study employed R Studio software version 4.3.3 (R Project for Statistical Computing) for data analysis. The specific methodologies are detailed below:

Analysis Principles Primary analysis set: Intent-to-treat (ITT) analysis Randomization method: Stratified randomization by study center

Data Distribution Assessment Normality of continuous variables was evaluated using the Shapiro-Wilk test Normally distributed data: Presented as mean ± standard deviation (Mean ± SD) Non-normally distributed data: Presented as median (interquartile range, Median [IQR])

Intergroup comparison methods Continuous variables

For normally distributed data:

Intergroup comparisons among three groups were performed using one-way analysis of variance (ANOVA).

When ANOVA showed significant differences (P < 0.05), pairwise comparisons were conducted using Student's t-test with Bonferroni correction.

For non-normally distributed data:

Intergroup comparisons were performed using the Kruskal-Wallis nonparametric test.

When significant differences were detected, pairwise comparisons were conducted using the Mann-Whitney U test.

Median differences were calculated using Hodges-Lehmann estimators with 95% confidence intervals (95% CI).

Categorical variables were presented as frequency (percentage, n (%)), Intergroup comparisons were performed using chi-square test (χ² test) or Fisher's exact test (for small sample sizes).

Statistical Significance Criteria:

All tests were two-sided, Significance threshold: P < 0.05.

Multiple comparison adjustment: When performing multiple pairwise comparisons, the significance level (α) was adjusted to 0.05/number of comparisons (Bonferroni method)

Study end points will be assessed via in-person interview (during hospitalisation), medical record review, telephone interview(after hospital discharge).

This study is designed as a Pilot study to provide data reference for future large-sample studies. The study plans to include 30 patients per group, totaling 90 patients across three groups.

Statistical Analysis: The statistical analysis software used was SAS 9.4. ① For the primary outcome measures, continuous variables were analyzed and expressed using standard deviation mean or interquartile range median, and the distribution type of the data was assessed for normality. Categorical variables were represented by counts and percentages. A modified intention-to-treat (ITT) analysis was employed. Randomization was stratified by hospital. The risk of the primary outcome was compared within each group. Additionally, the primary outcome measures could also be analyzed using a generalized linear model to adjust for potential confounding factors, Risk Ratio (crude, adjusted), and their 95% CI. The model was adjusted for the type of surgery and sensitivity analysis was performed to clarify the impact of data missingness on the robustness of the model. ② For the analysis of secondary outcome measures, depending on the variable situation, different types of variables were analyzed using generalized linear models, generalized estimating equations, Winratio, and COX regression, respectively.

Analysis of Data: All analyses were two-tailed tests, with a statistically significant difference set at P<0.05.

Expected test progress: 30 days

Being tested
Combined Lumbar Plexus and Sacral Plexus Block, iliac fascial block, spinal anesthesia
Keywords
nerve block, hip fracture, elderly, postoperative delirium, organ protection
Medical subject headings
Hip Fractures, Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined Lumbar Plexus and Sacral Plexus BlockProcedure or surgery

    Also called Lumbar - Sacral Plexus Block, Lumbosacral Plexus Block, Lumbosacral Plexus Nerve Block, Lumbosacral Regional Nerve Block

    This intervention of Combined Lumbar Plexus and Sacral Plexus Block is assigned to Nerve block anesthesia group (NA group): A combined Lumbar Plexus Block (0.33% Ropivacaine 30ml) and Sacral Plexus Block (0.33% Ropivacaine 20ml) administered as a single injection.

  • iliac fascial blockProcedure or surgery

    Also called iliac fascial compartment block, Fascia Iliaca Block, Fascia Iliaca Nerve Block, Fascia Iliaca Block Technique

    iliac fascial block administered as a single injection below the iliac fascial with 0.33% ropivacaine 30ml.

  • spinal anesthesiaProcedure or surgery

    Also called spinal block, intrathecal anesthesia

    Spinal anesthesia was performed as a standard care of spinal anesthetic. The spinal puncture site is at L2-3 or L3-4. After the puncture needle reaches the subarachnoid space, 1% ropivacaine 0.8-2 ml, totaling 8-20mg, is injected. Depending on the center's practice, it may be replaced with an equivalent dose of bupivacaine .

Study groups in NCT06696404
Study groupRoleWhat they receive
NA groupExperimentalNerve block anesthesia group(NA) Intervention: combined Lumbar Plexus and Sacral Plexus Block, with sedation or laryngeal mask anesthesia (induction with Propofol 1-3mg/kg, Sufentanil 0.1-0.4ug/kg)
Receives: Procedure: Combined Lumbar Plexus and Sacral Plexus Block
GA groupActive comparatorGeneral anesthesia was performed as an endotracheal intubation combined with iliac fascial block (0.33 ropivacaine 30 ml)
Receives: Procedure: iliac fascial block
SA groupActive comparatorSpinal anesthesia was performed as a standard care of spinal anesthetic
Receives: Procedure: spinal anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of of postoperative delirium

    Incidence of of postoperative delirium within 7 days or before discharge (whichever comes first) is assessed by 3-Minute Diagnostic Interview for Confusion Assessment Method(3D-CAM) scale. Each item in the 3D-CAM instrument directly informs one of the 4 CAM features in the algorithm that leads to determining the presence or absence of delirium.The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness. Negative indicates that the paticipant did not experience delirium at the time of assessment, which is favorable for the paticipant. Positive indicates that the participant is experiencing delirium at the time of assessment.

    Measured: From enrollment to the seventh day after surgery or before discharge

Secondary outcomes (10)

  1. Postoperative pain score

    Postoperative pain score within 3 days after surgery is assessed by visual analogue scale pain score(during resting and movement ).The Visual Analogue Scale (VAS) for pain assessment is commonly used to quantify the severity of pain experienced by participants. The VAS is a simple, continuous scale that is easy to administer and score. A straight line, usually 10 centimeter (cm) in length, is drawn on a piece of paper or presented on a digital device. The endpoints of the line represent the extremes of pain experienced by participants.The left end of the line is anchored with the phrase "No Pain" (0 cm).The right end of the line is anchored with the phrase "Worst Possible Pain" (10 cm).Participants are asked to mark a point on the line that they feel represents their current level of pain.Lower scores( between 0 to 3 ) indicate less severe pain, while higher scores (4-10) indicate more severe pain.

    Measured: From enrollment to the third day after surgery

  2. Consumption of opioid medications

    The consumption of opioid medications is calculated by translating the number of times a patient activates a patient-controlled analgesia (PCA) pump and any additional analgesics prescribed postoperatively into equivalent doses of morphine.This method allows for a standardized assessment of opioid usage across different types of medications and formulations, providing a consistent metric for evaluating pain management strategies and outcomes. Smaller amount of opioid comsuption is good for patients.

    Measured: From the start of surgery to the seventh day after surgery or at discharge

  3. Central nervous system complications

    Central nervous system complications within 30 days after surgery is confirmed by CT, MRI or other imaging evidence. Central nervous system complications includes stroke and transient cerebral ischemia.Stroke is defined as the sudden onset of acute neurological deficits, confirmed by CT, MRI, or other imaging evidence, and requiring medical intervention such as anticoagulant therapy.Transient Ischemic Attack (TIA) is defined as a new onset of acute neurological dysfunction caused by cerebral ischemia, lasting less than 1 hour, with no evidence of acute infarction on imaging studies of the head. Medical interventions such as medication (e.g., antiplatelet agents, lipid-lowering drugs) and interventional surgery are required.

    Measured: From the start of surgery to the thirtieth day after surgery

  4. Cognitive function

    Cognitive function within 30 days after surgery is assessed by Telephone Montreal Cognitive Assessment(T-MoCA) scale.The T-MoCA is a telephone-based adaptation of the widely recognized Montreal Cognitive Assessment (MoCA), designed to provide a rapid and efficient screening tool for cognitive impairment. It plays a pivotal role in cognitive function assessment by offering a convenient and remote method to evaluate multiple cognitive domains, including attention, concentration, executive functions, memory, language, visuospatial skills, abstraction, calculation, and orientation.The T-MoCA is particularly valuable in diverse community samples, where it has demonstrated sufficient psychometric properties to screen for mild cognitive impairment (MCI), especially in situations where in-person clinic visits are not feasible. A T-MoCA scale less than 18 indicates MCI, and is not good for participants.

    Measured: From enrollment to the thirtieth day after surgery

  5. Cardiovascular system complications

    Cardiovascular system complications within 30 days after surgery is assessed by through a variety of diagnostic measures. Cardiovascular system complications within 30 days after surgery include myocardial injury, angina, myocardial infarction (heart attack), heart failure, new-onset arrhythmias, and sudden cardiac arrest. Cardiovascular complications are assessed through a variety of diagnostic measures, including elevated troponin levels indicating myocardial injury, symptoms of myocardial ischemia or heart failure, newly diagnosed arrhythmias identified through electrocardiograms (ECGs), and additional evidence from imaging studies such as echocardiograms, nuclear scans, MRI, or CT angiography.

    Measured: From enrollment to the thirtieth day after surgery

  6. Acute kidney injury (AKI)

    Acute kidney injury (AKI) within 30 days after surgery is assessed using the Kidney Disease: Improving Global Outcomes (KDIGO) scoring system.The KIDGO scoring system is a standardized classification system defines AKI based on changes in serum creatinine levels and urine output. According to the KDIGO guidelines, AKI is defined as any of the following criteria within a 48-hour period: an increase in serum creatinine (SCr) of ≥0.3 mg/dL, or an increase to ≥1.5 times the baseline SCr that is known or presumed to have occurred within the prior seven days, or a urine volume of less than 0.5 mL/kg/hr for six hours.

    Measured: From enrollment to the thirtieth day after surgery

  7. Inflammatory factors

    Inflammatory factors within 3 days after surgery assessed by serum test. Inflammatory indicators include IL-6, CRP, TNF-α etc. Higher inflammatory factors may indicate higher inflammatory response, and is not good for participants.

    Measured: From enrollment to the third day after surgery

  8. Other related complications

    Other related complications and outcomes within 30 days after surgery assessed via chart review by site staff using standardised outcome definitions, including pulmonary infection, pulmonary edema, hypoxemia, respiratory failure, renal failure, gastrointestinal bleeding,stress ulcer, obstruction etc.

    Measured: From enrollment to the thirieth day after surgery

  9. Mortality

    Mortality during hospitalization and 30 days after surgery were obtained through follow-up or telephone-interviews.Data on the mortality outcome were obtained through telephone interviews by trial staff who were unaware of the treatment assignments.

    Measured: From enrollment to the thirtieth day after surgery

  10. Other outcomes

    Other outcomes were obtained from follow-up for 1 year of discharge: cognitive function, quality of life, mental condition, mortality via telephone interviewsFollow-up for 1 year of discharge: cognitive function, quality of life, mortality via telephone interviews. Cognitive function is assessed by T-MoCA scale, quality of life is assessed by Activity of Daily Living Scale (ADL scale).

    Measured: From enrollment to one year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2024
  2. Study start1 Dec 2024
  3. Primary completion12 Mar 2025
  4. Study completion5 Apr 2025

Resources

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
Model description
1. Nerve block anesthesia group (NA group): Combined Lumbar Plexus(0.33% ropivacaine 30ml)and Sacral Plexus Block(0.33% ropivacaine 20ml) + sedation or laryngeal mask anesthesia 2. General anesthesia group (GA group): General anesthesia (Endotracheal intubation) + iliac fascial block(0.33% ropivacaine 30ml) 3. Spinal anesthesia group (SA group): Spinal anesthesia with ropivacaine 8-20 mg or an equivalent dose of Bupivacaine.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06696404
Sponsor's protocol ID
2024-147-（1）
Acronym
PASPOP
Status last verified
Apr 2025
First submitted
7 Nov 2024
Last updated
30 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The data sharing policy is currently under development and is expected to be updated by December 2025.

Publications

  • Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

    PubMed 33238043

  • Abou-Setta AM, Beaupre LA, Rashiq S, Dryden DM, Hamm MP, Sadowski CA, Menon MR, Majumdar SR, Wilson DM, Karkhaneh M, Mousavi SS, Wong K, Tjosvold L, Jones CA. Comparative effectiveness of pain management interventions for hip fracture: a systematic review. Ann Intern Med. 2011 Aug 16;155(4):234-45. doi: 10.7326/0003-4819-155-4-201108160-00346.

    PubMed 21844549

  • Kim CH, Yang JY, Min CH, Shon HC, Kim JW, Lim EJ. The effect of regional nerve block on perioperative delirium in hip fracture surgery for the elderly: A systematic review and meta-analysis of randomized controlled trials. Orthop Traumatol Surg Res. 2022 Feb;108(1):103151. doi: 10.1016/j.otsr.2021.103151. Epub 2021 Nov 23.

    PubMed 34826609

  • Cai L, Song Y, Wang Z, She W, Luo X, Song Y. The efficacy of fascia iliaca compartment block for pain control after hip arthroplasty: A meta-analysis. Int J Surg. 2019 Jun;66:89-98. doi: 10.1016/j.ijsu.2018.12.012. Epub 2019 Jan 24.

    PubMed 30685517

  • Gao Y, Tan H, Sun R, Zhu J. Fascia iliaca compartment block reduces pain and opioid consumption after total hip arthroplasty: A systematic review and meta-analysis. Int J Surg. 2019 May;65:70-79. doi: 10.1016/j.ijsu.2019.03.014. Epub 2019 Mar 25.

    PubMed 30922995

  • Memtsoudis SG, Cozowicz C, Bekeris J, Bekere D, Liu J, Soffin EM, Mariano ER, Johnson RL, Go G, Hargett MJ, Lee BH, Wendel P, Brouillette M, Kim SJ, Baaklini L, Wetmore DS, Hong G, Goto R, Jivanelli B, Athanassoglou V, Argyra E, Barrington MJ, Borgeat A, De Andres J, El-Boghdadly K, Elkassabany NM, Gautier P, Gerner P, Gonzalez Della Valle A, Goytizolo E, Guo Z, Hogg R, Kehlet H, Kessler P, Kopp S, Lavand'homme P, Macfarlane A, MacLean C, Mantilla C, McIsaac D, McLawhorn A, Neal JM, Parks M, Parvizi J, Peng P, Pichler L, Poeran J, Poultsides L, Schwenk ES, Sites BD, Stundner O, Sun EC, Viscusi E, Votta-Velis EG, Wu CL, YaDeau J, Sharrock NE. Peripheral nerve block anesthesia/analgesia for patients undergoing primary hip and knee arthroplasty: recommendations from the International Consensus on Anesthesia-Related Outcomes after Surgery (ICAROS) group based on a systematic review and meta-analysis of current literature. Reg Anesth Pain Med. 2021 Nov;46(11):971-985. doi: 10.1136/rapm-2021-102750. Epub 2021 Aug 25.

    PubMed 34433647

  • O'Gara BP, Gao L, Marcantonio ER, Subramaniam B. Sleep, Pain, and Cognition: Modifiable Targets for Optimal Perioperative Brain Health. Anesthesiology. 2021 Dec 1;135(6):1132-1152. doi: 10.1097/ALN.0000000000004046.

    PubMed 34731233

  • Yoshimura M, Shiramoto H, Koga M, Yoshimatsu A, Morimoto Y. Comparing the effects of peripheral nerve block and general anesthesia with general anesthesia alone on postoperative delirium and complications in elderly patients: a retrospective cohort study using a nationwide database. Reg Anesth Pain Med. 2022 May 30:rapm-2022-103566. doi: 10.1136/rapm-2022-103566. Online ahead of print.

    PubMed 35636781

  • Li T, Li J, Yuan L, Wu J, Jiang C, Daniels J, Mehta RL, Wang M, Yeung J, Jackson T, Melody T, Jin S, Yao Y, Wu J, Chen J, Smith FG, Lian Q; RAGA Study Investigators. Effect of Regional vs General Anesthesia on Incidence of Postoperative Delirium in Older Patients Undergoing Hip Fracture Surgery: The RAGA Randomized Trial. JAMA. 2022 Jan 4;327(1):50-58. doi: 10.1001/jama.2021.22647.

    PubMed 34928310

  • 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

  • Griffiths R, Babu S, Dixon P, Freeman N, Hurford D, Kelleher E, Moppett I, Ray D, Sahota O, Shields M, White S. Guideline for the management of hip fractures 2020: Guideline by the Association of Anaesthetists. Anaesthesia. 2021 Feb;76(2):225-237. doi: 10.1111/anae.15291. Epub 2020 Dec 2.

    PubMed 33289066

  • Sciard D, Cattano D, Hussain M, Rosenstein A. Perioperative management of proximal hip fractures in the elderly: the surgeon and the anesthesiologist. Minerva Anestesiol. 2011 Jul;77(7):715-22. Epub 2011 Feb 1.

    PubMed 21283071

  • Vaurio LE, Sands LP, Wang Y, Mullen EA, Leung JM. Postoperative delirium: the importance of pain and pain management. Anesth Analg. 2006 Apr;102(4):1267-73. doi: 10.1213/01.ane.0000199156.59226.af.

    PubMed 16551935

  • Lynch EP, Lazor MA, Gellis JE, Orav J, Goldman L, Marcantonio ER. The impact of postoperative pain on the development of postoperative delirium. Anesth Analg. 1998 Apr;86(4):781-5. doi: 10.1097/00000539-199804000-00019.

    PubMed 9539601

  • Shen Y, Liu W, Zhu Z, Liu S, Cao Y, Yan L, Chen L. Application of a preoperative pain management mode based on instant messaging software in elderly hip fracture patients: a randomized controlled trial. BMC Geriatr. 2023 Mar 30;23(1):186. doi: 10.1186/s12877-023-03905-2.

    PubMed 36991402

Questions about this trial

What is this clinical trial studying?

A study testing Combined Lumbar Plexus and Sacral Plexus Block, iliac fascial block and spinal anesthesia in people with Elderly (People Aged 65 or More) and Hip Fracture, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 2 sites 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 3 inclusion and 8 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 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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?

Incidence of of postoperative delirium (time frame: From enrollment to the seventh day after surgery or before discharge). 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 NCT06696404, which also lists 20 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 30 Apr 2025.

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