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

Not Applicable

Completed

• Conditions: Postoperative Cognitive Dysfunction
• Interventions: Behavioral: The assessment of cognitive function; Procedure: Thoracic paravertebral block; Behavioral: Measurement of cognitive function; Drug: Esketamine

• Registration Number: NCT05341375
• Lead Sponsor: The First Hospital of Qinhuangdao

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-04-06
• Primary Completion: 2022-01-27
• Status Verified: 2022-04
• Study First Submitted: 2022-04-03
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-22
• Study Completion: 2022-04-30
• Last Update Submitted: 2022-04-30
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Non-surgical controls	The assessment of cognitive function	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 TA	Measurement of cognitive function	Group TA received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction
Group TA	Thoracic paravertebral block	Group TA received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction
Group C	Measurement of cognitive function	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 TE	Thoracic paravertebral block	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 TE	Measurement of cognitive function	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 TE	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

Primary Outcome Measures

Name	Time	Method
Change in pain assessed by Visual Analogue Scale	One day after surgery	Divide the ruler into 10 equal parts, with 0-2 indicating no pain, 3-5 indicating mild pain, 6-8 indicating moderate pain, and 9-10 indicating severe pain.
Incidence of POCD at three months after surgery	Three months after surgery	The MMSE 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
Incidence of POCD at one day after surgery	One day after surgery	The MMSE 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 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

Secondary Outcome Measures

Name	Time	Method
The change of HR	pre-surgery;during the surgery;immediately after surgery	The change of Heart Rate(HR) among the three groups
The change of MAP	pre-surgery;during the surgery;immediately after surgery	The change of Mean Arterial Pressure(MAP) among the three groups
Anesthetic drug	during the surgery	The dosage of remifentanil and propofol in different groups were recorded

Trial Locations

Locations (1)

The First hosptial of Qinhuangdao; 🇨🇳 Qinhuangdao, China