Intraoperative S-ketamine to Prevent Postoperative Hyperalgesia in Patients Undergoing Video-assisted Thoracic Surgery

NCT05016128 | Unknown

• 1 other identifier: 2021-0442
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative hyperalgesia (POH) is a paradoxical clinical state of increased sensation of pain or increased sensitivity to non-painful stimuli at the site of surgery or at a surrounding area that was not directly injured. Opioid-induced hyperalgesia (OIH) and nociceptive-induced hyperalgesia (NIH) are the two main causes of POH.N-methyl-D-aspartate receptor (NMDAR) activation plays a central role in the development of POH.S-ketamine，which is a NMDA-receptor antagonist,has been on the market in china since 2019.The aim of this study is to evaluate the effects of S-ketamine on POH and chronic postoperative pain after video-assisted thoracic surgery.

Conditions

Postoperative Hyperalgesia

Outcome Measures

Primary Outcomes (1)

• the mechanical pain threshold around the incision

  the mechanical pain threshold was assessed by using 10 calibrated (4-300 g mm-2 ) hand-held Von Frey filaments (North Coast Medical Inc.USA)around the skin incision.The per pain threshold was defined as the smallest force (g mm-2 ) necessary to bend a von Frey hair, and perceived by the patient as three consecutive painful stimuli with approximately 10 s elapsing between two successive stimuli. The mechanical pain threshold was recorded as the mean of 6 measurements at 2 cm vertically above and below the middle and bilateral edges of the incision.

  Day1 after surgery

Secondary Outcomes (8)

• the mechanical pain threshold on the forearm

  the day before surgery

• the mechanical pain threshold

  Day1 after surgery

• the mechanical pain threshold

  Day2 after surgery

• the mechanical pain threshold around the incision

  Day2 after surgery

• postoperative pain scores

  up to day2 after surgery

Study Arms (2)

S-ketamine

EXPERIMENTAL

a 0.25 mg/kg bolus and 0.125 mg/kg/h via intravenous infusion during surgery

Drug: S-ketamine

Saline

PLACEBO COMPARATOR

a 0.25 mg/kg bolus and 0.125 mg/kg/h via intravenous infusion during surgery

Drug: saline

Interventions

S-ketamine DRUG

S-ketamine is used for preventing postoperative hyperalgesia,thus reducing the patient's acute postoperative pain

Also known as: esketamine

S-ketamine

saline DRUG

saline is used for control

Also known as: 0.9%saline

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status class I-III.
• elective single-port video-assisted thoracic surgery under general

You may not qualify if:

• a history of thoracic surgery
• a history of chronic pain
• ongoing pain treatment
• opioid drug or alcohol abuse
• a history of allergy to anesthetics
• obesity (body mass index \[BMI\] \>30 kg/m2 )
• pregnancy
• psychiatric disorders
• neurological disease
• severe diabetes
• renal or hepatic insufficiency
• uncontrolled hypertension, or arrhythmia

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second affiliated Hospital School of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

Esketamine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

LiNa Yu, doctor

CONTACT

13958033387; zryulina@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 23, 2021
• Study Start: August 17, 2021
• Primary Completion: December 30, 2021
• Study Completion: April 30, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)