CClinicalTrials.gg
CompletedNCT05364216Updated Aug 1, 2023

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

An interventional study of Measurement of cognitive function and Thoracic paravertebral block in Postoperative Cognitive Dysfunction, Acute Postoperative Pain and Chronic Postsurgical Pain, sponsored by The First Hospital of Qinhuangdao. Completed at 1 site in China. Open to participants aged 60 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by The First Hospital of Qinhuangdao · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
60 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Thoracic paravertebral block
  • Cognitive function
  • Chronic Postsurgical Pain
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 92 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

The First Hospital of Qinhuangdao is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
92 participants (actual)

Study arms

  • 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

  • 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 · Procedure: Thoracic paravertebral block

  • 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

Interventions

  • BehavioralMeasurement 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

    Also known as: assessment of POD

  • ProcedureThoracic 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

    Also known as: General anesthesia

  • BehavioralThe assessment of cognitive function

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: One day after surgery

  2. 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

    Time frame: Three months after surgery

  3. 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).

    Time frame: Five minutes after extubation

  4. 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).

    Time frame: One day after surgery

  5. 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).

    Time frame: Three months after surgery

Secondary outcomes

  1. The change of SBP/DP

    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

  2. The change of HR

    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

  3. 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

    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

  4. Anesthetic drug

    The dosage of remifentanil and propofol in different groups were recorded

    Time frame: during the surgery

07

Study locations

1 site
  • The First hosptial of Qinhuangdao
    Qinhuangdao, Hebei 066000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05364216
Lead sponsor
The First Hospital of Qinhuangdao
Responsible party
Sponsor
First posted
May 6, 2022
Start date
May 12, 2022
Primary completion
Feb 28, 2023
Completion
May 31, 2023
Last update
Aug 1, 2023

Study contacts

Qinshuang Liu, master
study director · The First hosptial of Qinhuangdao
Linyu Shi, master
study chair · The First hosptial of Qinhuangdao

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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