Effects of Thoracic Paravertebral Block Combined With S-ketamine on Postoperative Pain and Cognitive Function After Thoracoscopic Surgery

NCT ID: NCT05341375

Last Updated: 2022-05-06

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

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-06

Study Completion Date

2022-04-30

Brief Summary

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To investigate the effect of ultrasound-guided thoracic paravertebral nerve block combined with intraoperative infusion of s-ketamine on postoperative acute pain and cognitive function in patients with thoracoscopic surgery

Detailed Description

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A total of 120 patients who were admitted to Qinhuangdao First Hospital for and divided into control group (group C ), thoracic paravertebral nerve block combined with full Anesthesia group (group TA), thoracic paravertebral nerve block combined with intraoperative infusion of s-ketamine group ( group TE). 40 cases in each group. Group C received general anesthesia, group TA received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction, and group TE received s-ketamine anesthesia induction dose of 0.3 mg/kg on the basis of TA group. Anesthesia maintenance dose of 0.2ug/kg/h was pumped to 30min before the end of the operation. The MAP(Mean Artery Pressure) and HR(Heart Rate) of the three groups were recorded before surgery (T1), during the surgery (T2), immediately after surgery (T3). Compare the VAS(Visual analogue scale)in the ten minuses after extubation and one day afte surgery .The cognitive function of the three groups were evaluated by the Mini Mental State Scale (MMSE) on one day before surgery , one day after surgery , and three months after surgery . Compare the incidence of Postoperative Cognitive Disfuntion( POCD) among the three groups.

Conditions

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Postoperative Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 scale on one day before surgery, one day after surgery, and three months after surgery

Group Type OTHER

Measurement of cognitive function

Intervention Type BEHAVIORAL

Patients undergoing thoracoscopic surgery underwent general anesthesia.MMSE was assessed at one day before surgery, one day after surgery, and three months after surgery

Group TA

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

Group Type EXPERIMENTAL

Thoracic paravertebral block

Intervention Type PROCEDURE

The patient was placed in lateral supine position, and the T5 spinous process was moved 2 to 3cm 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

Measurement of cognitive function

Intervention Type BEHAVIORAL

Patients undergoing thoracoscopic surgery underwent general anesthesia.MMSE was assessed at one day before surgery, one day after surgery, and three months after surgery

Group TE

Group TE received s-ketamine anesthesia induction dose of 0.3 mg/kg on the basis of TA group. Anesthesia maintenance dose of 0.2ug/kg/h was pumped to 30min before the end of the operation

Group Type EXPERIMENTAL

Thoracic paravertebral block

Intervention Type PROCEDURE

The patient was placed in lateral supine position, and the T5 spinous process was moved 2 to 3cm 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

Esketamine

Intervention Type DRUG

Group TE received s-ketamine anesthesia induction dose of 0.3 mg/kg on the basis of TA group. Anesthesia maintenance dose of 0.2ug/kg/h was pumped to 30min before the end of the operation

Measurement of cognitive function

Intervention Type BEHAVIORAL

Patients undergoing thoracoscopic surgery underwent general anesthesia.MMSE was assessed at one day before surgery, one day after surgery, and three months after surgery

Non-surgical controls

Age and sex-matched community people are included for three sessions of MMSE test evaluation for calculation of POCD incidence as normal control to in Z value calculation of POCD incidence to rule out learning effect

Group Type OTHER

The assessment of cognitive function

Intervention Type BEHAVIORAL

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

Interventions

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Thoracic paravertebral block

The patient was placed in lateral supine position, and the T5 spinous process was moved 2 to 3cm 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

Esketamine

Group TE received s-ketamine anesthesia induction dose of 0.3 mg/kg on the basis of TA group. Anesthesia maintenance dose of 0.2ug/kg/h was pumped to 30min before the end of the operation

Intervention Type DRUG

Measurement of cognitive function

Patients undergoing thoracoscopic surgery underwent general anesthesia.MMSE was assessed at one day before surgery, one day after surgery, and three months after surgery

Intervention Type BEHAVIORAL

The assessment of cognitive function

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

Intervention Type BEHAVIORAL

Other Intervention Names

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General anesthesia Combined general anesthesia assessment of POCD

Eligibility Criteria

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Inclusion Criteria

* 18-24kg/m2
* American Society of Anesthesiologists (ASA) grades I-III
* The score of Mini Mental state examination≥24

Exclusion Criteria

* Patients with heart, lung and other vital organ disorders
* The score of Mini Mental state examination≤23
* 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
* Refuse to sign informed consent
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 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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PI liuqinshuang, master

Role: STUDY_DIRECTOR

The First hosptial of Qinhuangdao

chenxiaodan chenxiaodan, master

Role: STUDY_CHAIR

The First hosptial of Qinhuangdao

Locations

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The First hosptial of Qinhuangdao

Qinhuangdao, , China

Site Status

Countries

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China

Other Identifiers

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201450450

Identifier Type: -

Identifier Source: org_study_id

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