Postoperative Cognitive DysfunctionNCT05364216
Effect of TPVB on Postoperative Pain and Cognitive Function After VATS in Elderly Patients
A study testing Measurement of cognitive function, Thoracic paravertebral block and The assessment of cognitive function in people with Postoperative Cognitive Dysfunction and Acute Postoperative Pain, run by The First Hospital of Qinhuangdao at 1 site in China.
Trial summary
To investigate the effect of ultrasound-guided thoracic paravertebral nerve block on postoperative acute and chronic pain and cognitive function in elderly patients with thoracoscopic partial lung resection. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Acute Postoperative Pain, Chronic Postsurgical Pain
- What is being tested?
- Measurement of cognitive function, Thoracic paravertebral block and The assessment of cognitive function
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2022to 31 May 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI less than 30 kg/m2
- American Society of Anesthesiologists (ASA) grades I-III
- The score of Mini Mental state examination≥24
- The score of Montreal Cognitive Assessment-Beijing Scale≥26
Who cannot join
- Patients with heart, lung, brain and other vital organ disorders
- The score of Mini Mental state examination≤23
- The score of Montreal Cognitive Assessment-Beijing Scale≤25
- Preoperative psychiatric disorders or long-term use of drugs affecting the psychiatric system
- Have severe visual, hearing, speech impairment or other inability to communicate with the visitor
- Have contraindications to thoracic parathymic block
- Refuse to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Thoracic Paravertebral Block on Chronic Pain and Cognitive Function After Thoracoscopic Partial Pulmonary Resection in Elderly Patients
To investigate the effect of ultrasound-guided thoracic paravertebral nerve block on postoperative acute and chronic pain and cognitive function in elderly patients with thoracoscopic partial lung resection.
Read the detailed description
A total of 92 patients who were admitted to Qinhuangdao First Hospital for and divided into control group (group C ), thoracic paravertebral nerve block combined with general anesthesia group (group T).
Group C received general anesthesia, and group T received 0.375% ropivacaine 20 ml of thoracic paravertebral nerve block combined with general anesthesia after induction of anesthesia. SBP（Systolic Blood Pressure）/DBP （Diastolic Pressure）and HR（Heart Rate） of the two groups were recorded before anesthesia induction (T1), at the time of intubation (T2), at the beginning of surgery (T5), immediately after surgery (T6), and five minutes after extubation (T7) . rScO2（Regional cerebral oxygen saturation） was recorded in both groups at (T1), five minutes after induction(T3), five minutes after single lung ventilation on lateral recumbent(T4), (T6), (T7). The incidence of acute and chronic pain after surgery was compared between the two groups by NRS（Numerical Rating Scale）after extubation , one day after surgery, and three months after surgery.
The cognitive function of the two groups was assessed with the Mini Mental State Scale (MMSE) and the Montreal Cognitive Assessment Scale (MoCA-Beijing) on the day before , one day after and three months after surgery, comparing the incidence of PND (postoperative cognitive dysfunction) between the two groups.Analyze whether paravertebral block can reduce the incidence of POD by improving brain oxygen saturation.
- Being tested
- Measurement of cognitive function, Thoracic paravertebral block, The assessment of cognitive function
- Keywords
- Thoracic paravertebral block, Cognitive function, Chronic Postsurgical Pain
- Medical subject headings
- Postoperative Cognitive Complications, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of cognitive functionBehavioural
Also called assessment of POD
Patients undergoing thoracoscopic surgery underwent general anesthesia.MMSE and MoCA were assessed at one day before surgery, one day after surgery, and three months after surgery
Thoracic paravertebral blockProcedure or surgery
Also called General anesthesia
The patient was placed in lateral supine position, and the T5 spinous process was moved 2 to 3 cm laterally to the operative side as the puncture point, and the pleura and T5 transverse process were observed, and the paraspinal space was observed on the lower lateral side of the transverse process. Using in-plane technique, the needle position was adjusted under ultrasound visualization to reach the paraspinal space. 20ml 0.375% ropivacaine was injected into the suction syringe when there was no blood or gas, and the drug liquid could be seen spreading outside the pleura. "Landscape sign" appeared, indicating successful block
The assessment of cognitive functionBehavioural
Participants were assessed for MMSE and MoCA at the same period as the group C
| Study group | Role | What they receive |
|---|---|---|
| Group C | Other | The general anesthesia was used.In this group, cognitive function was evaluated by MMSE and MoCA scale on one day before surgery, one day after surgery, and three months after surgery. Acute postoperative pain was was evaluated by VAS after extubation , one day after surgery, Chronic postsurgical pain was evaluated by VAS on three months after surgery. Receives: Behavioral: Measurement of cognitive function |
| Group T | Experimental | Group T received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction. Receives: Behavioral: Measurement of cognitive function; Procedure: Thoracic paravertebral block |
| Non-surgical controls | Other | Age and sex-matched community people are included for three sessions of MMSE test evaluation for calculation of POD incidence as normal control to in Z value calculation of POD incidence to rule out learning effect. Receives: Behavioral: The assessment of cognitive function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POD at one day after surgery
The MMSE and MoCA difference between the patients on the day before surgery and one day after surgery was compared and substituted into the formula.The formula of Z-scoring method is Z= (XC-X) /SDXC, where X refers to the change value of patients' MMSE/MoCA score at one day before surgery and one day after surgery. XC is the mean change value of the non-surgical control group at the same time, and SDXC is the standard deviation of the change value of the non-surgical control group. Finally, the Z-value at one day after surgery is calculated respectively. If the value of Z is ≥1.96, the patient is considered to have developed POCD
Measured: One day after surgery
Incidence of POD at three months after surgery
The MMSE and MoCA difference between the patients on the day before surgery and three months after surgery was compared and substituted into the formula.The formula of Z-scoring method is Z= (XC-X) /SDXC, where X refers to the change value of patients' MMSE score at one day before surgery and three months after surgery. XC is the mean change value of the non-surgical control group at the same time, and SDXC is the standard deviation of the change value of the non-surgical control group. Finally, the Z-value at three months after surgery is calculated respectively. If the value of Z is ≥1.96, the patient is considered to have developed POCD
Measured: Three months after surgery
Change in pain assessed by Visual Analogue Scale
Divide the ruler into 10 equal parts, with 0 means no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain(Patients have mild restrictions on daily activities or mild sleep disturbances due to pain，maybe require additional analgesic treatment), and 7-10 indicating severe pain(Patients are unable to fall asleep and cannot perform daily activities，they strongly request the use of analgesics).
Measured: Five minutes after extubation
Change in pain assessed by Visual Analogue Scale
Divide the ruler into 10 equal parts, with 0 means no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain(Patients have mild restrictions on daily activities or mild sleep disturbances due to pain，maybe require additional analgesic treatment), and 7-10 indicating severe pain(Patients are unable to fall asleep and cannot perform daily activities，they strongly request the use of analgesics).
Measured: One day after surgery
Change in pain assessed by Visual Analogue Scale
Divide the ruler into 10 equal parts, with 0 means no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain(Patients have mild restrictions on daily activities or mild sleep disturbances due to pain，maybe require additional analgesic treatment), and 7-10 indicating severe pain(Patients are unable to fall asleep and cannot perform daily activities，they strongly request the use of analgesics).
Measured: Three months after surgery
Secondary outcomes (4)
The change of SBP/DP
The change of Systolic blood pressure(SBP) and Diastolic pressure(DP) among the two groups
Measured: before anesthesia induction , at the time of intubation , at the beginning of surgery , immediately after surgery , and five minutes after extubation
The change of HR
The change of Heart rate(HR) among the two groups
Measured: before anesthesia induction , at the time of intubation , at the beginning of surgery , immediately after surgery , and five minutes after extubation
The change of rScO2, maximum and minimum of rScO2, duration of 10% below the base value
The change of regional cerebral oxygen saturation(rScO2), maximum and minimum of rScO2, duration of 10% below the base value among the two groups
Measured: before anesthesia induction , five minutes after induction, five minutes after single lung ventilation on lateral recumbent, immediately after surgery, and five minutes after extubation
Anesthetic drug
The dosage of remifentanil and propofol in different groups were recorded
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start12 May 2022
- Primary completion28 Feb 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Qinhuangdao
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Qinshuang Liu, master, Study director, The First hosptial of QinhuangdaoLinyu Shi, master, Study chair, The First hosptial of Qinhuangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364216
- Sponsor's protocol ID
- 20220503
- Status last verified
- Jul 2023
- First submitted
- 4 May 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Paravertebral Block on Chronic Pain and Cognitive Function After Thoracoscopic Partial Pulmonary Resection in Elderly Patients
- ClinicalTrials.gov ID
- NCT05364216
- Acronym / sponsor ID
- 20220503
- Keywords
- Thoracic paravertebral block, Cognitive function, Chronic Postsurgical Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 12 May 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 6 May 2022 (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.
To investigate the effect of ultrasound-guided thoracic paravertebral nerve block on postoperative acute and chronic pain and cognitive function in elderly patients with thoracoscopic partial lung resection.
Detailed description
A total of 92 patients who were admitted to Qinhuangdao First Hospital for and divided into control group (group C ), thoracic paravertebral nerve block combined with general anesthesia group (group T).
Group C received general anesthesia, and group T received 0.375% ropivacaine 20 ml of thoracic paravertebral nerve block combined with general anesthesia after induction of anesthesia. SBP（Systolic Blood Pressure）/DBP （Diastolic Pressure）and HR（Heart Rate） of the two groups were recorded before anesthesia induction (T1), at the time of intubation (T2), at the beginning of surgery (T5), immediately after surgery (T6), and five minutes after extubation (T7) . rScO2（Regional cerebral oxygen saturation） was recorded in both groups at (T1), five minutes after induction(T3), five minutes after single lung ventilation on lateral recumbent(T4), (T6), (T7). The incidence of acute and chronic pain after surgery was compared between the two groups by NRS（Numerical Rating Scale）after extubation , one day after surgery, and three months after surgery.
The cognitive function of the two groups was assessed with the Mini Mental State Scale (MMSE) and the Montreal Cognitive Assessment Scale (MoCA-Beijing) on the day before , one day after and three months after surgery, comparing the incidence of PND (postoperative cognitive dysfunction) between the two groups.Analyze whether paravertebral block can reduce the incidence of POD by improving brain oxygen saturation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Other | Behavioral: Measurement of cognitive functionThe general anesthesia was used.In this group, cognitive function was evaluated by MMSE and MoCA scale on one day before surgery, one day after surgery, and three months after surgery. Acute postoperative pain was was evaluated by VAS after extubation , one day after surgery, Chronic postsurgical pain was evaluated by VAS on three months after surgery. |
| Group T | Experimental | Behavioral: Measurement of cognitive function, Procedure: Thoracic paravertebral blockGroup T received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction. |
| Non-surgical controls | Other | Behavioral: The assessment of cognitive functionAge and sex-matched community people are included for three sessions of MMSE test evaluation for calculation of POD incidence as normal control to in Z value calculation of POD incidence to rule out learning effect. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI less than 30 kg/m2
- American Society of Anesthesiologists (ASA) grades I-III
- The score of Mini Mental state examination≥24
- The score of Montreal Cognitive Assessment-Beijing Scale≥26
Key exclusion criteria (7 listed)
- Patients with heart, lung, brain and other vital organ disorders
- The score of Mini Mental state examination≤23
- The score of Montreal Cognitive Assessment-Beijing Scale≤25
- Preoperative psychiatric disorders or long-term use of drugs affecting the psychiatric system
- Have severe visual, hearing, speech impairment or other inability to communicate with the visitor
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 |
|---|---|---|
| Measurement of cognitive functionAlso: assessment of PODPatients undergoing thoracoscopic surgery underwent general anesthesia.MMSE and MoCA were assessed at one day before surgery, one day after surgery, and three months after surgery | Behavioural | Group C, Group T |
| Thoracic paravertebral blockAlso: General anesthesiaThe patient was placed in lateral supine position, and the T5 spinous process was moved 2 to 3 cm laterally to the operative side as the puncture point, and the pleura and T5 transverse process were observed, and the paraspinal space was observed on the lower lateral side of the transverse process. Using in-plane technique, the needle position was adjusted under ultrasound visualization to reach the paraspinal space. 20ml 0.375% ropivacaine was injected into the suction syringe when there was no blood or gas, and the drug liquid could be seen spreading outside the pleura. "Landscape sign" appeared, indicating successful block | Procedure or surgery | Group T |
| The assessment of cognitive functionParticipants were assessed for MMSE and MoCA at the same period as the group C | Behavioural | Non-surgical controls |
Primary outcome
Incidence of POD at one day after surgery
Time frame: One day after surgery
The MMSE and MoCA difference between the patients on the day before surgery and one day after surgery was compared and substituted into the formula.The formula of Z-scoring method is Z= (XC-X) /SDXC, where X refers to the change value of patients' MMSE/MoCA score at one day before surgery and one day after surgery. XC is the mean change value of the non-surgical control group at the same time, and SDXC is the standard deviation of the change value of the non-surgical control group. Finally, the Z-value at one day after surgery is calculated respectively. If the value of Z is ≥1.96, the patient is considered to have developed POCD
Incidence of POD at three months after surgery
Time frame: Three months after surgery
The MMSE and MoCA difference between the patients on the day before surgery and three months after surgery was compared and substituted into the formula.The formula of Z-scoring method is Z= (XC-X) /SDXC, where X refers to the change value of patients' MMSE score at one day before surgery and three months after surgery. XC is the mean change value of the non-surgical control group at the same time, and SDXC is the standard deviation of the change value of the non-surgical control group. Finally, the Z-value at three months after surgery is calculated respectively. If the value of Z is ≥1.96, the patient is considered to have developed POCD
Change in pain assessed by Visual Analogue Scale
Time frame: Five minutes after extubation
Divide the ruler into 10 equal parts, with 0 means no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain(Patients have mild restrictions on daily activities or mild sleep disturbances due to pain，maybe require additional analgesic treatment), and 7-10 indicating severe pain(Patients are unable to fall asleep and cannot perform daily activities，they strongly request the use of analgesics).
Change in pain assessed by Visual Analogue Scale
Time frame: One day after surgery
Divide the ruler into 10 equal parts, with 0 means no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain(Patients have mild restrictions on daily activities or mild sleep disturbances due to pain，maybe require additional analgesic treatment), and 7-10 indicating severe pain(Patients are unable to fall asleep and cannot perform daily activities，they strongly request the use of analgesics).
Change in pain assessed by Visual Analogue Scale
Time frame: Three months after surgery
Divide the ruler into 10 equal parts, with 0 means no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain(Patients have mild restrictions on daily activities or mild sleep disturbances due to pain，maybe require additional analgesic treatment), and 7-10 indicating severe pain(Patients are unable to fall asleep and cannot perform daily activities，they strongly request the use of analgesics).
4 secondary outcomes
The change of SBP/DP
Time frame: before anesthesia induction , at the time of intubation , at the beginning of surgery , immediately after surgery , and five minutes after extubation
The change of HR
Time frame: before anesthesia induction , at the time of intubation , at the beginning of surgery , immediately after surgery , and five minutes after extubation
The change of rScO2, maximum and minimum of rScO2, duration of 10% below the base value
Time frame: before anesthesia induction , five minutes after induction, five minutes after single lung ventilation on lateral recumbent, immediately after surgery, and five minutes after extubation
Anesthetic drug
Time frame: during the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qinshuang Liu, master study director
The First hosptial of Qinhuangdao
Linyu Shi, master study chair
The First hosptial of Qinhuangdao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of cognitive function, Thoracic paravertebral block and The assessment of cognitive function in people with Postoperative Cognitive Dysfunction and Acute Postoperative Pain, run by The First Hospital of Qinhuangdao 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 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. 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?
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 POD at one day after surgery (time frame: One day after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2023.