Charoenwisetsin, Suwis
Jiranantarat, Vorakran
Hirunyachoke, Paphon
Udomkiat, Pacharapol
Funding for this research was provided by:
Mahidol University
Article History
Received: 14 March 2024
Accepted: 24 July 2024
First Online: 1 August 2024
Declarations
:
: The study was conducted after approval by the Siriraj Institutional Review Board, Certificate of Approval COA no. Si 544/2020, and all participants gave their informed consent to participate. Siriraj Institutional Review Board is in full compliance with international guidelines for human research protection such as the Declaration of Helsinki, the Belmont Report, CIOMS Guidelines, and the International Conference on Harmonization in Good Clinical Practice (ICH-GCP).
: Not Applicable.
: Our study adheres to CONSORT guidelines
: The cold may cause discomfort to the participants, but they will be provided with appropriate warmth during and after the surgery. Participants may have an allergic reaction to the drugs used in the research at the same risk level as the general population. Adverse reactions or side effects from the drugs used in the research can range from mild, such as drowsiness, confusion, and difficulty urinating, to severe, such as severe allergic reactions, renal failure, etc. Patients at risk of severe side effects will be excluded from the research from the outset. Blood drawing may cause bruising or skin infections at the puncture site. If any adverse events occur, participants will receive immediate and close medical care according to standards. Personal and research-related data of the participants will be kept confidential.Reasons that may lead to the withdrawal of research participants from the study:• Participants expressed a desire to withdraw from the research project.• Severe side effects from the drugs used in the study or allergic reactions to the study drugs necessitate discontinuation of the medication.• Participants who receive anesthesia through methods other than spinal injections combined with specific nerve block anesthesia in the inner thigh area.• Participants undergoing knee replacement surgery who require the addition of other devices to the standard prosthesis due to complications during surgery, such as bone fractures or torn ligaments.
: I hereby express my consent to participate in the research project titled " Effect of intraoperative cold solution irrigation to reduce postoperative pain in knee osteoarthritis patients who underwent unilateral primary total knee arthroplasty: A double-blinded randomized controlled trial” I have been fully informed about the background and objectives of the research, the procedures I will undergo or be subjected to, the expected benefits of the research, and the potential risks that may arise from participating in the research, including measures for prevention and remediation in case of harm. I have also been informed about the costs that I will be responsible for, as detailed in the research participant information sheet, which I have read. Furthermore, I have had the opportunity to ask questions and have received satisfactory answers from the research leader. Therefore, I willingly agree to participate in this research project. Should I have any concerns about the research procedures or if I experience any undesirable side effects from the research, I can contact Assoc. Prof. Dr. Pacharapol Udomkiat, Telephone number: +6683-038-3399 and Dr. Suwis Charoenwisetsin, Telephone numbers: +6684-148-0019, Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wang Lang Road, Bangkok, Bangkok Noi 10700, Thailand.If I am treated in a manner not consistent with the information provided in the research participant information sheet, wish to discuss any concerns, have questions, or require additional information about the research, I can contact SIRB chairman, Office of Siriraj Institutional Review Board, Room 210, 2nd floor of His majesty the King’s 80th Birthday Anniversary 5th December 2007 Building, Telephone 66 2419 2667-72 Fax 66 2411 0162.I am aware of my rights to receive further information regarding the benefits and risks of participating in the research and to withdraw or refrain from participating at any time without prior notice or providing a reason, without affecting my future medical care and services.I also consent to the researchers using my personal data obtained from the research, which will not be disclosed to the public individually but may be presented as aggregate data from the research.In cases where the research participant/volunteer is unable to read, a witness who has no conflict of interest will be present throughout the information provision process. The research participant/volunteer or their legally authorized representative gives consent to participate in the research. The witness confirms that the consent form or the information received and any other documents have been accurately explained and that the research participant/volunteer or their legally authorized representative has demonstrated an understanding of the details and has voluntarily given consent by signing as a witness.
: The authors declare no competing interests.