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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Cognitive Dysfunction; Acute Postoperative Pain; Chronic Postsurgical Pain
• Intervention / Treatment: Behavioral: Measurement of cognitive function; Procedure: Thoracic paravertebral block; Behavioral: The assessment of cognitive function

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Qinhuangdao, Hebei, China, 066000
      • The First hosptial of Qinhuangdao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group C; 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.	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; Other Names: assessment of POD
Experimental: Group T; Group T received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction.	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; Other Names: assessment of POD; 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; Other Names: General anesthesia
Other: Non-surgical controls; 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.	Behavioral: The assessment of cognitive function; Participants were assessed for MMSE and MoCA at the same period as the group C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Anesthetic drug	The dosage of remifentanil and propofol in different groups were recorded	during the surgery

Collaborators and Investigators

• Sponsor: The First Hospital of Qinhuangdao
• Investigators: Study Director: Qinshuang Liu, master, The First hosptial of Qinhuangdao; Study Chair: Linyu Shi, master, The First hosptial of Qinhuangdao

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Cognitive function; Thoracic paravertebral block; Chronic Postsurgical Pain
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Neurocognitive Disorders; Cognition Disorders; Pain, Postoperative; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: 20220503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No