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AnesthesiaNCT01782612

The Assessments of the Postoperative Recovery on Elderly Patients Received General Anesthesia or Peripheral Nerve Blocks

A study testing Multimodal analgesic techniques and Total uni-Hip Replacement in people with Anesthesia and Hip Osteoarthritis, run by Junle Liu at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Postoperative recovery is always worrisome to the elder patients undergoing Total Hip Replacement (THR). Peripheral Nerve Blocks (PNBs), lumbar plexus block combined with sciatic nerve blocks, may be alterative anaesthesia style to the fragile patients. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Anesthesia, Hip Osteoarthritis
What is being tested?
Multimodal analgesic techniques and Total uni-Hip Replacement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
Mar 2013to Mar 2014
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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age > 75years old
  • Undergoing primary total uni-hip arthroplasty surgery
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Mini-Mental score examination (MMSE) being more than 23

Who cannot join

  • Patient refusal to participate in the study
  • Failure of regional block
  • Insulin dependent diabetes
  • Allergic to local anesthetics or general anesthetics
  • History of opioid dependence
  • Contraindications to nerve blocks (coagulation defects, infection at puncture site, preexisting neurological deficits in the lower extremities)
Show all 9Show fewer
  • Patient refusal to participate in the study
  • Current severe psychiatric disease or alcoholism or drug dependence
  • Severe visual or auditory disorder

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital

    Beijing, Beijing Municipality, 100853

    Zhang Hong, Director, 0086-10-66937462, mazuimao301@yahoo.com.cn

    Wang Xiaolin, wangxiaol1025@yahoo.com

    Recruiting

Other trials in China

About this study

Official title: Comparison of Peripheral Nerve Blocks With General Anesthesia on Elderly Patients Undergoing Total Hip Replacement (THR) by Assessing the Postoperative Recovery and Delirium

Postoperative recovery is always worrisome to the elder patients undergoing Total Hip Replacement (THR). Peripheral Nerve Blocks (PNBs), lumbar plexus block combined with sciatic nerve blocks, may be alterative anaesthesia style to the fragile patients. But pervious papers suggested PNBs were commonly administered in conjunction with general anesthesia (GA), or the blocks were performed primarily for postoperative analgesia. Hardly any research has reported in use of Peripheral Nerve Blocks (PNBs) as primary anesthesia style for Total Hip Replacement (THR). The investigators compare peripheral nerve blocks to general anesthesia on elderly eld patients undergoing Total Hip Replacement (THR) by assessing the Postoperative Recovery and Delirium

Read the detailed description

Patients will be followed by a blinded investigator for a 7days period to record the development of Cardiovascular and Pulmonary complications defined by a broad composite that included all-cause mortality, acute myocardial infarction, unstable angina, congestive heart failure, new atrial or ventricular dysrhythmia requiring treatment, cerebrovascular insult, pneumonia, and acute respiratory distress syndrome (ARDS).

Protocol This will be a randomized, prospective, single-center, assessor blinded study comparing two different anesthesia styles in 150 elderly patients undergoing primary total hip arthroplasty. We expect to enroll all patients in a 7 days period postoperation.

The study will be performed according to the Declaration of Helsinki principles, and written informed consent will be obtained from each patient. Preoperatively baseline values will be obtained for the cardiovascular, mental status, respiratory measures.

Mental status: During their preoperative visit patients will be given the neuropsychological tests in the Modified Mini-Mental State Examination. This extended measure of general cognition was developed to overcome shortcomings of the traditional Mini-Mental State Examination score, specifically its ceiling effects and narrow range of possible scores.

Each patient will be interviewed by the same trained research assistant before surgery and during the postoperative visits.

Postoperative Delirium and postoperative recovery will be recorded by an assessor blinded to the allocation.

Patients will be randomly allocated to two groups on the day of surgery using a computer generated assignment. GA Group will receive general anaesthesia and PNBs group will receive Peripheral Nerve Blocks.

General anaesthesia:A standardized balanced anesthetic technique was provided in GA group. Briefly, after standard external monitors, pulse oximeter, electrocardiogram, noninvasive blood pressure, were applied on subject's arrival in the operation room. Subjects had an intravenous line placed in the upper extremity. Anesthesia was administered with midazolam (0.015-0.03 mg.kg-1), fentanyl (1.8-3.5µg.kg-1), etomidate (0.2-0.3mg.kg-1) and rocuronium (0.4-0.6 mg.kg-1), and then suitable laryngeal mask airway (LMA) was facilitated with a respiratory rate of 10-12 bpm, an I:E ratio of 1:2, positive end-respiratory pressure of 5 cm H2O and an fraction of inspired oxygen (FiO2) of 0.4. Tidal volume will be adjusted to an end tidal carbon dioxide of 35-40 mmHg. Maintaining with remifentanil (0.15-0.30 µg.kg-1.min-1), target concentrations of propofol (0.6-2.0 µg.mL-1) and sevoflurane (0.8 MAC) with 100% oxygen. Infusion rates of propofol and remifentanil varied according to clinical judgment and bispectral index (BIS) range between 40 and 60. All procedures were performed by two veteran anaesthetists.

Peripheral Nerve Blocks (PNBs):Patients received midazolam (0.015-0.03 mg.kg-1), fentanyl (1.5-2.5µg.kg-1) by infusion, in divided doses, before lumbar plexus and sciatic nerve blocking and supplemental 100% oxygen (3 L.min-1) was administered by facemask spontaneously breathing during the procedure. The procedure was performed by two anesthesiologists with extensive experience in nerve block. After sterile preparation and draping, PNBs were administered using a 21-gauge, 100-mm simplex block needle and a nerve stimulator. A posterior approach to lumbar plexus block was performed with patient in the lateral decubitus position and after a quadriceps muscle response had been identified with nerve stimulator settings at 2 hertz frequency and current between 0.3 and 0.5 milliampere(mA), and 0.4% ropivacaine (25-30 mL) was injected slowly. Sciatic nerve block was performed in the same position after a twitch of hamstrings, soleus, foot, or toes, had been elicited using the similar current, and 0.4% ropivacaine (15-20 mL) was injected slowly. Sensory and motor blocks on the operated limb were evaluated every 5 min after completion of the procedure until achievement of adequate sensory (loss of pinprick sensation on both the lumbar plexus and sciatic nerve distributions) and motor (inability to extend the leg with the knee passively flexed) blocks. Sedation during the surgery procedure was provided by propofol (0.3-1.5 µg.mL-1) with the aim of maintaining BIS (60-80), light sleep with easy being aroused.

Every patient shows signs of inadequate anesthesia such as an increase in systolic arterial blood pressure>20% from baseline or a heart rate greater than 90 in the absence of hypovolemia, sweating, flushing or movement fentanyl, 50-100 µg, may be administered. Persistent hypertension without signs of inadequate anesthesia will be treated with nicardipine, 0.4 mg IV, every 3 min until return to baseline value. In both groups patients with a heart rate less than 50 bpm not correlated with blood pressure variation will receive atropine 0.3 mg every 3 minutes until heart rate is back to at least 50 bpm. In all patients, from anesthetic induction to end of surgery, a decrease in systolic blood pressure of more than 30% less than baseline values will be treated with ephedrine 6 mg or phenylephrine 100 µg every 3 min until return to baseline value. Propofol will be stopped at completion of skin closure. Intraoperatively, each patient will also receive 2 mg of tropisetron to decrease postoperative nausea.

The doses of all IV drugs and duration of anesthesia and surgery will be recorded. Ephedrine and phenylephrine consumption and the amount of intravascular fluid administration and all the intraoperative drug dose adjustments will be recorded. The esophageal temperature of the patients will be monitored and maintained at 36 C using a force-air warming blanket and warmed i.v. fluids. Postoperative Recovery of the PQRS will be measured on presurgery, 15 minute, 40 minute, 1 day, 3day, 7day postoperatively. Postoperative Delirium will be measured on 1 day,2 day, 3day postoperatively.

Being tested
Multimodal analgesic techniques, Total uni-Hip Replacement
Keywords
Balanced Anesthesia, Nerve Block, Postoperative Recovery, Delirium, Postoperative Complications, Stress, Inflammation
Medical subject headings
Osteoarthritis, Hip, Delirium, Postoperative Complications, Inflammation

What participants receive

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

  • Multimodal analgesic techniquesProcedure or surgery

    Postoperative pain was controlled for all patients routinely by intravenous sulfentanil patient-controlled analgesia (PICA) in combination with Parecoxib(40 mg, every 12 h). PICA was continued with sulfentanil (1.25 µg.h-1) and 1.25 µg sulfentanil bolus with a 8-min lockout time. Oral oxycodone 0.2 mg was administered necessarily.

  • Total uni-Hip ReplacementProcedure or surgery

    All subjects will undergo standard Total uni-Hip Replacement

Study groups in NCT01782612
Study groupRoleWhat they receive
General AnsethesiaActive comparatorSubjects undergoing Total uni-Hip Replacement will receive standard General Anesthesia with Laryngeal Mask Airway and Multimodal analgesic techniques
Receives: Procedure: Multimodal analgesic techniques; Procedure: Total uni-Hip Replacement
Peripheral Nerve BlocksExperimentalSubjects undergoing Total uni-Hip Replacement will receive Lumbar plexus block and Sciatic nerve block with 0.4% Ropivacaine and Multimodal analgesic techniques
Receives: Procedure: Multimodal analgesic techniques; Procedure: Total uni-Hip Replacement

What is being measured

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

  1. Postoperative recovery by the Post-operative Quality Recovery Scale (PQRS)

    Measured: 7days

Secondary outcomes (1)
  1. Postoperative Delirium

    Measured: 72 hours

Timeline

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

  1. First posted4 Feb 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionDec 2013 (estimated)
  4. Study completionMar 2014 (estimated)

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
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01782612
Sponsor's protocol ID
THPPLA2013
Status last verified
Mar 2013
First submitted
28 Jan 2013
Last updated
13 Mar 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.

    PubMed 20601860

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal analgesic techniques and Total uni-Hip Replacement in people with Anesthesia and Hip Osteoarthritis, run by Junle Liu 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 4 inclusion and 9 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 13 Mar 2013. 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?

Contact Zhang Hong, Ph.D (0086-10-66937462, mazuimao301@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative recovery by the Post-operative Quality Recovery Scale (PQRS) (time frame: 7days). 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 NCT01782612, 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 13 Mar 2013.

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