Clinical trial NCT05364216: Effect of TPVB on Postoperative Pain and Cognitive Function After VATS in Elderly Patients
Official title: Effect of Thoracic Paravertebral Block on Chronic Pain and Cognitive Function After Thoracoscopic Partial Pulmonary Resection in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Acute Postoperative Pain
Chronic Postsurgical Pain
Keywords: Thoracic paravertebral block
Cognitive function
Chronic Postsurgical Pain
Lead sponsor: The First Hospital of Qinhuangdao
Sponsor class: OTHER_GOV
First posted: 2022-05-06
Enrollment: 92
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of POD at one day after surgery
timeFrame: One day after surgery
measure: Incidence of POD at three months after surgery
timeFrame: Three months after surgery
measure: Change in pain assessed by Visual Analogue Scale
timeFrame: Five minutes after extubation
measure: Change in pain assessed by Visual Analogue Scale
timeFrame: One day after surgery
measure: Change in pain assessed by Visual Analogue Scale
timeFrame: Three months after surgery
Secondary outcomes:
measure: The change of SBP/DP
timeFrame: before anesthesia induction , at the time of intubation , at the beginning of surgery , immediately after surgery , and five minutes after extubation
measure: The change of HR
timeFrame: before anesthesia induction , at the time of intubation , at the beginning of surgery , immediately after surgery , and five minutes after extubation
measure: The change of rScO2, maximum and minimum of rScO2, duration of 10% below the base value
timeFrame: before anesthesia induction , five minutes after induction, five minutes after single lung ventilation on lateral recumbent, immediately after surgery, and five minutes after extubation
measure: Anesthetic drug
timeFrame: during the surgery
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: The First hosptial of Qinhuangdao
state: Hebei
Study officials:
affiliation: The First hosptial of Qinhuangdao
name: Qinshuang Liu, master
role: STUDY_DIRECTOR
affiliation: The First hosptial of Qinhuangdao
name: Linyu Shi, master
role: STUDY_CHAIR
References: