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

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

Tracking Information

• First Submitted Date: April 3, 2022
• First Posted Date: April 22, 2022
• Last Update Posted Date: May 6, 2022
• Actual Study Start Date: April 6, 2021
• Actual Primary Completion Date: January 27, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 21, 2022)

• 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
• 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
• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 21, 2022)

• Anesthetic drug [ Time Frame: during the surgery ]
  The dosage of remifentanil and propofol in different groups were recorded
• 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
• The change of HR [ Time Frame: pre-surgery;during the surgery;immediately after surgery ]
  The change of Heart Rate(HR) among the three groups

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Thoracic Paravertebral Block Combined With S-ketamine on Postoperative Pain and Cognitive Function After Thoracoscopic Surgery
• Official Title: Effects of Thoracic Paravertebral Block Combined With S-ketamine on Postoperative Pain and Cognitive Function After Thoracoscopic Surgery
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Prevention
• Condition: Postoperative Cognitive Dysfunction

Intervention

• 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
• Behavioral: The assessment of cognitive function
  Participants were assessed for MMSE at the same period as the group C

Study Arms

• 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
  Intervention: Behavioral: Measurement of cognitive function
• Experimental: Group TA
  Group TA received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction
  Interventions:

  • Procedure: Thoracic paravertebral block
  • Behavioral: Measurement of cognitive function
• 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
  Interventions:

  • Procedure: Thoracic paravertebral block
  • Drug: Esketamine
  • Behavioral: Measurement of cognitive function
• 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
  Intervention: Behavioral: The assessment of cognitive function

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 30, 2022): 110
• Original Estimated Enrollment (submitted: April 21, 2022): 120
• Actual Study Completion Date: April 30, 2022
• Actual Primary Completion Date: January 27, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05341375
• Other Study ID Numbers: 201450450
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: The First Hospital of Qinhuangdao
• Original Responsible Party: Same as current
• Current Study Sponsor: The First Hospital of Qinhuangdao
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: The First Hospital of Qinhuangdao
• Verification Date: April 2022