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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Cognitive Dysfunction
• Intervention / Treatment: Behavioral: Measurement of cognitive function; Procedure: Thoracic paravertebral block; Drug: Esketamine; Behavioral: The assessment of cognitive function

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Qinhuangdao, China
    • The First hosptial of Qinhuangdao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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	Behavioral: 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; Other Names: assessment of POCD
EXPERIMENTAL: Group TA; Group TA received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction	Behavioral: 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; Other Names: assessment of POCD; Procedure: 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; Other Names: General anesthesia
EXPERIMENTAL: 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	Behavioral: 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; Other Names: assessment of POCD; Procedure: 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; Other Names: General anesthesia; Drug: 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; Other Names: Combined general anesthesia
OTHER: 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	Behavioral: The assessment of cognitive function; Participants were assessed for MMSE at the same period as the group C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of POCD at 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	One day after surgery
Incidence of POCD at 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	Three months after surgery
Change in pain assessed by Visual Analogue Scale	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.	Ten minutes after extubation
Change in pain assessed by Visual Analogue Scale	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.	One day after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Hospital of Qinhuangdao
• Investigators: Study Director: PI liuqinshuang, master, The First hosptial of Qinhuangdao; Study Chair: chenxiaodan chenxiaodan, master, The First hosptial of Qinhuangdao

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 6, 2021
• Primary Completion (ACTUAL): January 27, 2022
• Study Completion (ACTUAL): April 30, 2022

Study Registration Dates

• First Submitted: April 3, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (ACTUAL): April 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2022
• Last Update Submitted That Met QC Criteria: April 30, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Cognitive function; Thoracic paravertebral block; Esketamine
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Neurocognitive Disorders; Cognition Disorders; Pain, Postoperative; Cognitive Dysfunction; Postoperative Cognitive Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Psychotropic Drugs; Antidepressive Agents; Anesthetics; Esketamine
• Other Study ID Numbers: 201450450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No