Analgesic Effect of Intraoperative Intravenous S-Ketamine During Total Knee Arthroplasty Surgery:A Randomized Controlled Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- sodium chloride (NaCl; 0.9%)
- Conditions
- Postoperative Pain, Acute
- Sponsor
- Ling Dong
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- at rest and movement, evaluated NRS at 24hours after surgery in the surgical ward.
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
Severe acute pain after total knee arthroplasty surgery has multiple implications for hospitals and patients, monopolising resources and affecting the quality of life. S-ketamine inhibits N-methyl-d-aspartate (NMDA) receptor activation and attenuates central sensitization associated with hyperalgesia, opioid tolerance.Therefore, the primary aim of this trial was to investigate whether s-ketamine decreases pain and opioid consumption postoperatively in adult individuals undergoing total knee arthroplasty surgery.
Detailed Description
Total knee arthroplasty surgery is considered a cost-effective therapy for end-stage knee osteoarthritis (KOA). With an ageing population and rising rates of obesity in the world, knee joint replacements are estimated to escalate. While joint replacement is a cost effective intervention,approximately 20% of people experience persist pain postoperatively. The surgical injury triggers a myriad of responses in the pain matrix, from sensitization of peripheral and central pain pathways to feelings of fear, anxiety and frustration. Opioids are effective for acute postoperative pain but have numerous adverse effects. In addition, postoperative opioid treatment may pose a risk of opioid addiction. Numerous publications state that adjuvant s-ketamine reduces pain and opioid consumption postoperatively . Whether intraoperative intravenous s-ketamine alleviates postoperative acute pain after total knee arthroplasty surgery still unclear . Therefore, a randomized, controlled, clinical study was designed to observed analgesic effect intraoperative intravenous a lower doses of s-ketamine(0.3mg/kg/h) with patients after total knee arthroplasty surgery .
Investigators
Ling Dong
clinical professor
Qianfoshan Hospital
Eligibility Criteria
Inclusion Criteria
- •ASA physical statusI-III;
- •Patients understood the study in detail and voluntarily signed the informed consent before the study;
- •Patients to be treated with total knee arthroplasty Surgery under General anesthesia;
- •Elderly patients(≥65y),regardless of gender;
- •Patients can communicate normally;
- •Patients who have no contraindications to drugs such as midazolam,fentanyl,s-ketamine.
- •7.18 kg/m2 ≤BMI≤30 kg/m2;
Exclusion Criteria
- •Increased intracranial or intraocular pressure;
- •severe hypertension;
- •unwillingness the study;
- •severe psychiatric disease and mental system diseases;
- •severe respiratory diseases;
- •hyperthyroidism;
- •liver and kidney dysfunction;
- •alcohol or drug abuse;
- •allergy to midazolam,fentanyl,s-ketamine.
Arms & Interventions
sodium chloride (NaCl; 0.9%)
For patients in the control group,anaesthesia will be maintained with intravenous sodium chloride (NaCl; 0.9%) infusion.while anaesthesia will be maintained with propofol infusion(4-12mg/kg/h),analgesia will be maintained with remifentanil(0.15-0.3ug/kg/min).The sufentanil dose at induction and the rate of intraoperative remifentanil and propofol infusions were at the discretion of the anesthesiologist in charge of the patient. The assessment of the depth of anesthesia was based on clinical evaluation,placebo-controlled infusion will be stopped 15 minutes before the end of surgery.Propofol and remifentanil infusion will be stopped at the end of surgery.
Intervention: sodium chloride (NaCl; 0.9%)
S-ketamine
For patients in the s-ketamine group, anaesthesia will be maintained with s-ketamine infusion（0.3mg/kg/h),while anaesthesia will be maintained with propofol infusion(4-12mg/kg/h) ,analgesia will be maintained with remifentanil(0.15-0.3ug/kg/min).The sufentanil dose at induction and the rate of intraoperative remifentanil and propofol infusions were at the discretion of the anesthesiologist in charge of the patient.The assessment of the depth of anesthesia was based on clinical evaluation.S-ketamine infusion will be stopped 15 minutes before the end of surgery.Propofol and remifentanil infusion will be stopped at the end of surgery.
Intervention: S-ketamine
Outcomes
Primary Outcomes
at rest and movement, evaluated NRS at 24hours after surgery in the surgical ward.
Time Frame: the patient at 24hours after operation.
NRS = (numerical rating scale) is widely used to measure pain intensity after surgery.NRS is evaluated on a 11-point NRS (0 = no pain, 10 = worst pain imaginable)
Secondary Outcomes
- at rest and movement, evaluated NRS at 2 hours after surgery in the surgical ward.(the patient at 2 hours after operation.)
- at rest and movement, evaluated NRS at 48hours after surgery in the surgical ward.(the patient at 48hours after operation)
- The cumulative Opioids consumption during the first 48h after operation(Within 48hours after surgery)
- The Opioids or non-steroid anti-inflammatory drugs total consumption during the first 48h after operation(Within 48hours after surgery)
- The number of patients who required additional analgesics during the first 48h after operation(Within 48hours after surgery)
- The incidence of PONV and adverse central nervous system (CNS) events.(at2, 24, 48hours after operation.)