Efficacy of paracetamol and mannitol injection in managing chronic post-thoracotomy pain following lung cancer surgery: Study protocol for a single center, prospective, randomized, double-blind, and controlled trial

Abstract

Abstract Background Chronic post-thoracotomy pain (CPTP) is a common complication after lung cancer surgery, involving 20% to 60% of patients. This persistent pain affects patients' quality of life and satisfaction with surgery. Paracetamol and mannitol injection, known for its analgesic and antipyretic properties, may help relieve moderate-to-severe postoperative pain. This trial aims to assess the effectiveness and safety of paracetamol and mannitol injection in managing CPTP after lung cancer surgery. Methods This is a prospective, double-blind, randomized controlled clinical trial conducted at a single center. A total of 394 patients scheduled for thoracoscopic radical surgery for lung cancer will be enrolled andrandomly assigned to test group (intravenous infusion of paracetamol and mannitol injection) or control group(intravenous infusion of normal saline) in a 1:1 ratio, with 197 patients in each group. The primary outcome is the incidence of CPTP at 3 months after surgery. Secondary outcomes include the dosage of propofol and remifentanil, numerical rating scale (NRS) pain scores, patient-controlled intravenous analgesia (PCIA) pressing times, the occurrence of postoperative nausea andvomiting, and respiratory depression, time to first flatus and ambulation after surgery, length of hospital stay, surgeon and patient satisfaction, and the incidence of CPTP at 6 and 12 months after surgery. The patient's quality of daily life will be evaluated at 3, 6, and 12 months after the surgery. Intention-to-treat (ITT) analysis will be conducted. Discussion We hypothesize that the use of intravenous paracetamol and mannitol injection can reduce the incidence and severity of CPTP and improve the quality of daily life. Additionally, the expected rate of adverse reactions from paracetamol and mannitol injection will be low. This trial will assess the effectiveness and safety of paracetamol and mannitol injection in managing CPTP after lung cancer surgery and provide scientific evidence for clinical practice. Trial Registration Chinese Clinical Trial Registry, Registration number: ChiCTR2300072869, 2023-06-27, https://www.chictr.org.cn/. Trial Status This trial is currently ongoing. Study execution period: July 1, 2023, to October 1, 2024. Recruiting period: August 1, 2023, to May 1, 2024. Version number and date: Version 1.1 of 08-20-2023