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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- 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
- 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
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.
- Conditions
- Anesthesia, Hip Osteoarthritis
- 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 group | Role | What they receive |
|---|---|---|
| General Ansethesia | Active comparator | Subjects 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 Blocks | Experimental | Subjects 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.
Postoperative recovery by the Post-operative Quality Recovery Scale (PQRS)
Measured: 7days
Secondary outcomes (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.
- First posted4 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013 (estimated)
- Study completionMar 2014 (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 AnesthesiaStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Junle Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Junle Liu, Chinese PLA General Hospital
- Investigators
- Zhang Hong, Ph.D, Study chair, Professor and Director, Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01782612
- Acronym / sponsor ID
- THPPLA2013
- Conditions
- Anesthesia, Hip Osteoarthritis
- Keywords
- Balanced Anesthesia, Nerve Block, Postoperative Recovery, Delirium, Postoperative Complications, Stress, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Junle LiuUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 4 Feb 2013 (estimated)
- 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 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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Ansethesia | Active comparator | Procedure: Multimodal analgesic techniques, Procedure: Total uni-Hip ReplacementSubjects undergoing Total uni-Hip Replacement will receive standard General Anesthesia with Laryngeal Mask Airway and Multimodal analgesic techniques |
| Peripheral Nerve Blocks | Experimental | Procedure: Multimodal analgesic techniques, Procedure: Total uni-Hip ReplacementSubjects undergoing Total uni-Hip Replacement will receive Lumbar plexus block and Sciatic nerve block with 0.4% Ropivacaine and Multimodal analgesic techniques |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Multimodal analgesic techniquesPostoperative 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. | Procedure or surgery | General Ansethesia, Peripheral Nerve Blocks |
| Total uni-Hip ReplacementAll subjects will undergo standard Total uni-Hip Replacement | Procedure or surgery | General Ansethesia, Peripheral Nerve Blocks |
Primary outcome
Postoperative recovery by the Post-operative Quality Recovery Scale (PQRS)
Time frame: 7days
1 secondary outcome
Postoperative Delirium
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
- Background: PubMed 20601860Royse 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.
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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.
Zhang Hong, Ph.D study chair
Professor and Director, Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
1 site in 1 country: see every site and its status.
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.