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

NCT05364216 | Completed

• 1 other identifier: 20220503
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction; Acute Postoperative Pain; Chronic Postsurgical Pain

Keywords

Thoracic paravertebral block; Cognitive function; Chronic Postsurgical Pain

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• The change of SBP/DP

  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

  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

  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

  during the surgery

Study Arms (3)

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.

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.

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.

Behavioral: The assessment of cognitive function

Interventions

Measurement of cognitive function BEHAVIORAL

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

Also known as: assessment of POD

Group C; Group T

Thoracic paravertebral block PROCEDURE

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

Also known as: General anesthesia

Group T

The assessment of cognitive function BEHAVIORAL

Participants were assessed for MMSE and MoCA at the same period as the group C

Non-surgical controls

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Qinhuangdao: lead

Study Sites (1)

The First hosptial of Qinhuangdao

Qinhuangdao, Hebei, 066000, China

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications; Pain, Postoperative

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Qinshuang Liu, master

  The First hosptial of Qinhuangdao

  STUDY DIRECTOR

• Linyu Shi, master

  The First hosptial of Qinhuangdao

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 6, 2022
• Study Start: May 12, 2022
• Primary Completion: February 28, 2023
• Study Completion: May 31, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)