PMID- 38064260 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231225 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 12 DP - 2023 Dec 8 TI - Analgesic Effect of Intraoperative Intravenous S(+)-Ketamine During Total Knee Arthroplasty Surgery: Study Protocol for a Randomized Controlled Clinical Trial. PG - e53063 LID - 10.2196/53063 [doi] LID - e53063 AB - BACKGROUND: Total knee arthroplasty (TKA) is currently the main treatment for end-stage knee disease. The number of cases of TKA in China increased from 53,880 in 2011 to 374,833 in 2019, representing a 5.9-fold increase. Moderate to severe pain often occurs after TKA, which seriously affects postoperative rehabilitation, patient satisfaction, and overall outcome. Multimodal analgesia is considered the ideal solution. Adequate postoperative analgesia can not only reduce pain, opioid consumption, and, consequently, opioid-related adverse events, but can also reduce the length of hospital stay and costs and improve rehabilitation and patient satisfaction. OBJECTIVE: Effective multimodal pain management in the early postoperative period is essential for anesthesiologists. Additional studies have demonstrated that a low-dose intravenous infusion of ketamine can be administered as an adjuvant drug to alleviate acute postoperative pain. Therefore, we aim to appraise the efficacy and safety of intraoperative intravenous injection of S(+)-ketamine to relieve acute pain after TKA in older patients. METHODS: This is a protocol for a randomized, placebo-controlled trial. A total of 144 participants aged 65 years and older undergoing TKA will be randomly allocated into the S(+)-ketamine and placebo groups in a 1:1 ratio. S(+)-ketamine or the placebo will be intravenously administered at 0.3 mg/kg/h during the operation by anesthesiologists. Blinded evaluation by trained investigators will be completed at 2 hours, 24 hours, and 48 hours after surgery. The primary outcome measure will be the numeric rating scale score at rest and movement at 24 hours after surgery. The secondary outcomes will include the numeric rating scale scores at rest and movement at 2 hours and 48 hours after surgery, the number of patients who require additional analgesics during the first 48 hours after operation, the total consumption of opioids or nonsteroid anti-inflammatory drugs during the first 48 hours after operation, and adverse events at 2, 24, and 48 hours after operation. RESULTS: The protocol was registered at Clinical Trials.gov on February 26, 2022. It was performed in accordance with the approved guidelines and regulations of the participating institutions. Recruitment began in April 2022. Data collection is expected to conclude in September 2024. Study completion is expected in December 2024. CONCLUSIONS: A randomized, controlled, clinical study was designed to observe the analgesic effect of intraoperative intravenous administration of a lower dose of S(+)-ketamine (0.3 mg/kg/h) in older patients after TKA surgery. The protocol will appraise the efficacy and safety of intraoperative intravenous injection of S(+)-ketamine to relieve acute pain after TKA in older patients who may benefit from the administration of S(+)-ketamine. TRIAL REGISTRATION: ClinicalTrials.gov NCT05289050; https://clinicaltrials.gov/ct2/show/NCT05289050. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53063. CI - (c)Shiyuan Deng, Lina Chen, Xiao Song, Liang Guo, Fei Zhao, Jing Liu, Ling Dong. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 08.12.2023. FAU - Deng, Shiyuan AU - Deng S AUID- ORCID: 0000-0003-2836-3076 AD - Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University, Jinan, China. FAU - Chen, Lina AU - Chen L AUID- ORCID: 0000-0003-3271-2822 AD - Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University, Jinan, China. FAU - Song, Xiao AU - Song X AUID- ORCID: 0009-0009-2897-6746 AD - Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University, Jinan, China. FAU - Guo, Liang AU - Guo L AUID- ORCID: 0009-0007-5071-9610 AD - Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University, Jinan, China. FAU - Zhao, Fei AU - Zhao F AUID- ORCID: 0009-0004-7792-5607 AD - Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University, Jinan, China. FAU - Liu, Jing AU - Liu J AUID- ORCID: 0009-0004-1879-7684 AD - Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University, Jinan, China. FAU - Dong, Ling AU - Dong L AUID- ORCID: 0000-0002-6173-0221 AD - Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University, Jinan, China. LA - eng SI - ClinicalTrials.gov/NCT05289050 PT - Journal Article DEP - 20231208 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC10746976 OTO - NOTNLM OT - S(+)-ketamine OT - analgesic OT - older patients, multimodal pain management OT - total knee arthroplasty surgery COIS- Conflicts of Interest: None declared. EDAT- 2023/12/08 12:42 MHDA- 2023/12/08 12:43 PMCR- 2023/12/08 CRDT- 2023/12/08 11:54 PHST- 2023/09/25 00:00 [received] PHST- 2023/11/23 00:00 [accepted] PHST- 2023/11/09 00:00 [revised] PHST- 2023/12/08 12:43 [medline] PHST- 2023/12/08 12:42 [pubmed] PHST- 2023/12/08 11:54 [entrez] PHST- 2023/12/08 00:00 [pmc-release] AID - v12i1e53063 [pii] AID - 10.2196/53063 [doi] PST - epublish SO - JMIR Res Protoc. 2023 Dec 8;12:e53063. doi: 10.2196/53063.