Second Affiliated Hospital Zhejiang University School of Medicine
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- the mechanical pain threshold around the incision
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American Society of Anesthesiologists (ASA) physical status class I-III.
- •elective single-port video-assisted thoracic surgery under general
Exclusion Criteria
- •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
Arms & Interventions
S-ketamine
a 0.25 mg/kg bolus and 0.125 mg/kg/h via intravenous infusion during surgery
Intervention: S-ketamine (Drug)
Saline
a 0.25 mg/kg bolus and 0.125 mg/kg/h via intravenous infusion during surgery
Intervention: saline (Drug)
Outcomes
Primary Outcomes
the mechanical pain threshold around the incision
Time Frame: Day1 after surgery
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.
Secondary Outcomes
- the mechanical pain threshold on the forearm(the day before 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)
- Anxiety scale scores(up to day2 after surgery)
- Depression scale scores(up to day2 after surgery)
- The hyperalgesic area around the incision(up to day2 after surgery)