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Effect of TPVB on Postoperative Pain and Cognitive Function After VATS in Elderly Patients

Primary Purpose

Postoperative Cognitive Dysfunction, Acute Postoperative Pain, Chronic Postsurgical Pain

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Measurement of cognitive function
Thoracic paravertebral block
The assessment of cognitive function
Sponsored by
The First Hospital of Qinhuangdao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Cognitive Dysfunction focused on measuring Thoracic paravertebral block, Cognitive function, Chronic Postsurgical Pain

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • The First hosptial of Qinhuangdao

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Other

Arm Label

Group C

Group T

Non-surgical controls

Arm Description

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.

Group T received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction.

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.

Outcomes

Primary Outcome Measures

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
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
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).
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).
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).

Secondary Outcome Measures

The change of SBP/DP
The change of Systolic blood pressure(SBP) and Diastolic pressure(DP) among the two groups
The change of HR
The change of Heart rate(HR) among the two groups
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
Anesthetic drug
The dosage of remifentanil and propofol in different groups were recorded

Full Information

First Posted
May 4, 2022
Last Updated
July 28, 2023
Sponsor
The First Hospital of Qinhuangdao
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1. Study Identification

Unique Protocol Identification Number
NCT05364216
Brief Title
Effect of TPVB on Postoperative Pain and Cognitive Function After VATS in Elderly Patients
Official Title
Effect of Thoracic Paravertebral Block on Chronic Pain and Cognitive Function After Thoracoscopic Partial Pulmonary Resection in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Hospital of Qinhuangdao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction, Acute Postoperative Pain, Chronic Postsurgical Pain
Keywords
Thoracic paravertebral block, Cognitive function, Chronic Postsurgical Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Other
Arm Description
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.
Arm Title
Group T
Arm Type
Experimental
Arm Description
Group T received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction.
Arm Title
Non-surgical controls
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Measurement of cognitive function
Other Intervention Name(s)
assessment of POD
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Thoracic paravertebral block
Other Intervention Name(s)
General anesthesia
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
The assessment of cognitive function
Intervention Description
Participants were assessed for MMSE and MoCA at the same period as the group C
Primary Outcome Measure Information:
Title
Incidence of POD at one day after surgery
Description
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
Time Frame
One day after surgery
Title
Incidence of POD at three months after surgery
Description
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
Time Frame
Three months after surgery
Title
Change in pain assessed by Visual Analogue Scale
Description
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).
Time Frame
Five minutes after extubation
Title
Change in pain assessed by Visual Analogue Scale
Description
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).
Time Frame
One day after surgery
Title
Change in pain assessed by Visual Analogue Scale
Description
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).
Time Frame
Three months after surgery
Secondary Outcome Measure Information:
Title
The change of SBP/DP
Description
The change of Systolic blood pressure(SBP) and Diastolic pressure(DP) among the two groups
Time Frame
before anesthesia induction , at the time of intubation , at the beginning of surgery , immediately after surgery , and five minutes after extubation
Title
The change of HR
Description
The change of Heart rate(HR) among the two groups
Time Frame
before anesthesia induction , at the time of intubation , at the beginning of surgery , immediately after surgery , and five minutes after extubation
Title
The change of rScO2, maximum and minimum of rScO2, duration of 10% below the base value
Description
The change of regional cerebral oxygen saturation(rScO2), maximum and minimum of rScO2, duration of 10% below the base value among the two groups
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
Title
Anesthetic drug
Description
The dosage of remifentanil and propofol in different groups were recorded
Time Frame
during the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qinshuang Liu, master
Organizational Affiliation
The First hosptial of Qinhuangdao
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Linyu Shi, master
Organizational Affiliation
The First hosptial of Qinhuangdao
Official's Role
Study Chair
Facility Information:
Facility Name
The First hosptial of Qinhuangdao
City
Qinhuangdao
State/Province
Hebei
ZIP/Postal Code
066000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of TPVB on Postoperative Pain and Cognitive Function After VATS in Elderly Patients

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