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NCT Number: NCT05364216

Effect of TPVB on Postoperative Pain and Cognitive Function After VATS 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.

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Key information

Conditions

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

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First hosptial of Qinhuangdao

Qinhuangdao, Hebei, 066000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: assessment of POD

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

Other names: General anesthesia

The assessment of cognitive function

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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).

  4. 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).

  5. 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).

Secondary outcomes

  1. 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 Systolic blood pressure(SBP) and Diastolic pressure(DP) among the two groups

  2. 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 Heart rate(HR) among the two groups

  3. 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

    The change of regional cerebral oxygen saturation(rScO2), maximum and minimum of rScO2, duration of 10% below the base value among the two groups

  4. Anesthetic drug

    Time frame: during the surgery

    The dosage of remifentanil and propofol in different groups were recorded

Sponsors and collaborators

Lead sponsor

The First Hospital of Qinhuangdao

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 6, 2022
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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