S-ketamine Prevents Postoperative Pain and Cognitive Dysfunction After Tibial Fracture
S-ketamine Prevents Tibial Fracture-associated Postoperative Pain and Cognitive Dysfunction After Orthopedic Surgery in Patients: a Randomized Double-blind Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
Purpose: To explore effects of S-ketamine on postoperative pain and cognitive dysfunction after tibial fracture and orthopedic surgery. To evaluate and examine the incidence of adverse effects with the purpose of selecting the optimum dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2020
CompletedFirst Posted
Study publicly available on registry
November 24, 2020
CompletedStudy Start
First participant enrolled
December 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2021
CompletedAugust 13, 2021
August 1, 2021
11 months
November 17, 2020
August 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mechanical hyperalgesia threshold on the palms of feet
The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament.
48 hours after surgery
Secondary Outcomes (7)
Pain Score (NRS)
48 hours after surgery
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm
48 hours after surgery
Time of First Postoperative Analgesic Requirement
1 hour after surgery
Total Dose of First Postoperative Analgesic Requirement
1 hour after surgery
Cumulative Sufentanyl Consumption
48 hours after surgery
- +2 more secondary outcomes
Study Arms (3)
Normal saline in patients
PLACEBO COMPARATORAfter the induction of anesthesia, normal saline is intravenously injected in a volume of 2ml, and then a continuous infusion of 20 ml/h normal saline until starting skin suture.
S-ketamine at low dose in patients
ACTIVE COMPARATORAfter the induction of anesthesia, S-ketamine is intravenously injected at 0.2mg/kg, and then a continuous infusion of 0.2mg/kg/h S-ketamine until starting skin suture.
S-ketamine at high dose in patients
ACTIVE COMPARATORAfter the induction of anesthesia, S-ketamine is intravenously injected at 0.4mg/kg, and then a continuous infusion of 0.4mg/kg/h S-ketamine until starting skin suture.
Interventions
After the induction of anesthesia, normal saline is intravenously injected in a volume of 2ml, and then a continuous infusion of 20ml/h normal saline until starting skin suture.
After the induction of anesthesia, S-ketamine is intravenously injected at 0.2mg/kg, and then a continuous infusion of 0.2mg/kg/h S-ketamine until starting skin suture.
After the induction of anesthesia, S-ketamine is intravenously injected at 0.4mg/kg, and then a continuous infusion of 0.4mg/kg/h S-ketamine until starting skin suture.
Eligibility Criteria
You may qualify if:
- Subject is scheduled to undergo tibial fracture with orthopedic surgery under a short general anesthesia of less than 2 hours
- Subject's American Society of Anesthesiologists physical status is I-II.
- The subject's parent/legally authorized guardian has given written informed consent to participate.
You may not qualify if:
- Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure.
- Subject has a diagnosis of Insulin dependent diabetes.
- Subject is allergy and contraindication to S-ketamine.
- Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids.
- Subject has any contraindication for the use of patient-controlled analgesia (PCA).
- Subject is pregnant or breast-feeding.
- Subject is obese (body mass index \>30kg/m\^2).
- Subject is incapacity to comprehend pain assessment and cognitive assessment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University General Hospital
Tianjin, 300052, China
Related Publications (2)
Zhang L, Terrando N, Xu ZZ, Bang S, Jordt SE, Maixner W, Serhan CN, Ji RR. Distinct Analgesic Actions of DHA and DHA-Derived Specialized Pro-Resolving Mediators on Post-operative Pain After Bone Fracture in Mice. Front Pharmacol. 2018 May 1;9:412. doi: 10.3389/fphar.2018.00412. eCollection 2018.
PMID: 29765320BACKGROUNDCui W, Li Y, Wang Z, Song C, Yu Y, Wang G, Li J, Wang C, Zhang L. Spinal caspase-6 regulates AMPA receptor trafficking and dendritic spine plasticity through netrin-1 in postoperative pain after orthopedic surgery for tibial fracture in mice. Pain. 2021 Jan;162(1):124-134. doi: 10.1097/j.pain.0000000000002021.
PMID: 32701657BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Guolin Wang, MD
Tianjin Medical University General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 17, 2020
First Posted
November 24, 2020
Study Start
December 15, 2020
Primary Completion
November 15, 2021
Study Completion
December 15, 2021
Last Updated
August 13, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share