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

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ClinicalTrials.gov Identifier: NCT05341375
Recruitment Status : Completed
First Posted : April 22, 2022
Last Update Posted : May 6, 2022
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Postoperative Cognitive Dysfunction Procedure: Thoracic paravertebral block Drug: Esketamine Behavioral: Measurement of cognitive function Behavioral: The assessment of cognitive function Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Effects of Thoracic Paravertebral Block Combined With S-ketamine on Postoperative Pain and Cognitive Function After Thoracoscopic Surgery
Actual Study Start Date : April 6, 2021
Actual Primary Completion Date : January 27, 2022
Actual Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Esketamine

Arm Intervention/treatment
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 Name: 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
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 Name: General anesthesia

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 Name: assessment of POCD

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
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 Name: 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 Name: Combined general anesthesia

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 Name: assessment of POCD

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




Primary Outcome Measures :
  1. Incidence of POCD at one day after surgery [ Time Frame: 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

  2. Incidence of POCD at three months after surgery [ Time Frame: 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

  3. Change in pain assessed by Visual Analogue Scale [ Time Frame: Ten minutes after extubation ]
    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.

  4. Change in pain assessed by Visual Analogue Scale [ Time Frame: 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.


Secondary Outcome Measures :
  1. Anesthetic drug [ Time Frame: during the surgery ]
    The dosage of remifentanil and propofol in different groups were recorded

  2. The change of MAP [ Time Frame: pre-surgery;during the surgery;immediately after surgery ]
    The change of Mean Arterial Pressure(MAP) among the three groups

  3. The change of HR [ Time Frame: pre-surgery;during the surgery;immediately after surgery ]
    The change of Heart Rate(HR) among the three groups



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05341375


Locations
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China
The First hosptial of Qinhuangdao
Qinhuangdao, China
Sponsors and Collaborators
The First Hospital of Qinhuangdao
Investigators
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Study Director: PI liuqinshuang, master The First hosptial of Qinhuangdao
Study Chair: chenxiaodan chenxiaodan, master The First hosptial of Qinhuangdao
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Responsible Party: The First Hospital of Qinhuangdao
ClinicalTrials.gov Identifier: NCT05341375    
Other Study ID Numbers: 201450450
First Posted: April 22, 2022    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Hospital of Qinhuangdao:
Esketamine
Thoracic paravertebral block
Cognitive function
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Cognitive Complications
Cognitive Dysfunction
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Anesthetics
Esketamine
Central Nervous System Depressants
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs