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

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

Effect of Thoracic Paravertebral Block on Chronic Pain and Cognitive Function After Thoracoscopic Partial Pulmonary Resection in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05364216
• Other study ID #: 20220503
• Status: Completed
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2023
• Source: The First Hospital of Qinhuangdao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: May 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Postoperative Pain
• Chronic Postsurgical Pain
• Cognitive Dysfunction
• Pain, Postoperative
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Intervention

Behavioral:
• Measurement of cognitive function
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

Procedure:
• Thoracic paravertebral block
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

Behavioral:
• The assessment of cognitive function
Participants were assessed for MMSE and MoCA at the same period as the group C

Locations

Country	Name	City	State
China	The First hosptial of Qinhuangdao	Qinhuangdao	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Qinhuangdao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One day after surgery
Primary	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	Three months after surgery
Primary	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).	Five minutes after extubation
Primary	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).	One day after surgery
Primary	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).	Three months after surgery
Secondary	The change of SBP/DP	The change of Systolic blood pressure(SBP) and Diastolic pressure(DP) among the two groups	before anesthesia induction , at the time of intubation , at the beginning of surgery , immediately after surgery , and five minutes after extubation
Secondary	The change of HR	The change of Heart rate(HR) among the two groups	before anesthesia induction , at the time of intubation , at the beginning of surgery , immediately after surgery , and five minutes after extubation
Secondary	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	before anesthesia induction , five minutes after induction, five minutes after single lung ventilation on lateral recumbent, immediately after surgery, and five minutes after extubation
Secondary	Anesthetic drug	The dosage of remifentanil and propofol in different groups were recorded	during the surgery