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

NCT05341375 | Completed

• 1 other identifier: 201450450
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Cognitive Dysfunction

Keywords

Esketamine; Thoracic paravertebral block; Cognitive function

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Anesthetic drug

  during the surgery

• The change of MAP

  pre-surgery;during the surgery;immediately after surgery

• The change of HR

  pre-surgery;during the surgery;immediately after surgery

Study Arms (4)

Group C

OTHER

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

Group TA

EXPERIMENTAL

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

Procedure: Thoracic paravertebral block; Behavioral: Measurement of cognitive function

Group TE

EXPERIMENTAL

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

Procedure: Thoracic paravertebral block; Drug: Esketamine; Behavioral: Measurement of cognitive function

Non-surgical controls

OTHER

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

Interventions

Thoracic paravertebral block 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

Also known as: General anesthesia

Group TA; Group TE

Esketamine 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

Also known as: Combined general anesthesia

Group TE

Measurement of cognitive function 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

Also known as: assessment of POCD

Group C; Group TA; Group TE

The assessment of cognitive function BEHAVIORAL

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

Non-surgical controls

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Qinhuangdao: lead

Study Sites (1)

The First hosptial of Qinhuangdao

Qinhuangdao, China

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Anesthesia, General; Esketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• PI liuqinshuang, master

  The First hosptial of Qinhuangdao

  STUDY DIRECTOR

• chenxiaodan chenxiaodan, master

  The First hosptial of Qinhuangdao

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2022
• First Posted: April 22, 2022
• Study Start: April 6, 2021
• Primary Completion: January 27, 2022
• Study Completion: April 30, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)