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

NCT ID: NCT05364216

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2023-05-31

Brief Summary

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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

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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.

Conditions

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Postoperative Cognitive Dysfunction Acute Postoperative Pain Chronic Postsurgical Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type OTHER

Measurement of cognitive function

Intervention Type 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

Group T

Group T received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction.

Group Type EXPERIMENTAL

Measurement of cognitive function

Intervention Type 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

Thoracic paravertebral block

Intervention Type 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

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.

Group Type OTHER

The assessment of cognitive function

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

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

Intervention Type PROCEDURE

The assessment of cognitive function

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

Intervention Type BEHAVIORAL

Other Intervention Names

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assessment of POD General anesthesia

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Hospital of Qinhuangdao

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qinshuang Liu, master

Role: STUDY_DIRECTOR

The First hosptial of Qinhuangdao

Linyu Shi, master

Role: STUDY_CHAIR

The First hosptial of Qinhuangdao

Locations

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The First hosptial of Qinhuangdao

Qinhuangdao, Hebei, China

Site Status

Countries

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China

Other Identifiers

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20220503

Identifier Type: -

Identifier Source: org_study_id

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