Clinical trial NCT05289050: Analgesic Effect of Intraoperative Intravenous S-Ketamine During Total Knee Arthroplasty Surgery
Official title: Analgesic Effect of Intraoperative Intravenous S-Ketamine During Total Knee Arthroplasty Surgery:A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain, Acute
Anaesthetic
Keywords: Postoperative pain
total knee arthroplasty surgery
anaesthetic
S-ketamine infusion
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 144
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 .

Eligibility criteria: Inclusion Criteria:

1. ASA physical statusI-III;
2. Patients understood the study in detail and voluntarily signed the informed consent before the study;
3. Patients to be treated with total knee arthroplasty Surgery under General anesthesia;
4. Elderly patients(≥65y),regardless of gender;
5. Patients can communicate normally;
6. Patients who have no contraindications to drugs such as midazolam,fentanyl,s-ketamine.

7.18 kg/m2 ≤BMI≤30 kg/m2;

Exclusion Criteria:

1. Increased intracranial or intraocular pressure;
2. severe hypertension;
3. unwillingness the study;
4. severe psychiatric disease and mental system diseases;
5. severe respiratory diseases;
6. hyperthyroidism;
7. liver and kidney dysfunction;
8. alcohol or drug abuse;
9. allergy to midazolam,fentanyl,s-ketamine.

Primary outcomes:
measure: at rest and movement, evaluated NRS at 24hours after surgery in the surgical ward.
timeFrame: the patient at 24hours after operation.
Secondary outcomes:
measure: at rest and movement, evaluated NRS at 2 hours after surgery in the surgical ward.
timeFrame: the patient at 2 hours after operation.
measure: at rest and movement, evaluated NRS at 48hours after surgery in the surgical ward.
timeFrame: the patient at 48hours after operation
measure: The cumulative Opioids consumption during the first 48h after operation
timeFrame: Within 48hours after surgery
measure: The number of patients who required additional analgesics during the first 48h after operation
timeFrame: Within 48hours after surgery
measure: The Opioids or non-steroid anti-inflammatory drugs total consumption during the first 48h after operation
timeFrame: Within 48hours after surgery
measure: The incidence of PONV and adverse central nervous system (CNS) events.
timeFrame: at2, 24, 48hours after operation.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
state: Shandong
Study officials:
References: