Efficacy of intravenous paracetamol and mannitol in managing chronic post-thoracotomy pain in patients with lung cancer: Study protocol for a single center prospective randomized double-blind controlled trial

Abstract

Chronic post-thoracotomy pain is a common complication that affects 20% to 60% of patients who undergo surgery for lung cancer. The persistent pain affects quality of life and satisfaction with surgery. Intravenous paracetamol and mannitol, known to have analgesic and antipyretic properties, may help relieve moderate-to-severe post-operative pain. This trial aims to assess their effectiveness and safety in managing chronic post-thoracotomy pain in patients with lung cancer. This prospective double-blind randomized controlled clinical trial will be conducted at a single center. A total of 856 patients who will undergo thoracoscopic radical surgery for lung cancer will be enrolled and randomly assigned to test (intravenous paracetamol and mannitol) and control (intravenous normal saline) groups in a 1:1 ratio (428 patients in each group). Efficacy will be evaluated in terms of the incidence of chronic post-thoracotomy pain at 3 months (primary outcome). Secondary outcomes will include the dosage of propofol and remifentanil, numerical rating scale pain scores, number of times the patient-controlled intravenous analgesia button is pressed, occurrence of post-operative nausea and vomiting and respiratory depression, time to first flatus and ambulation after surgery, length of hospital stay, surgeon and patient satisfaction, and incidence of chronic post-thoracotomy pain at 6 and 12 months after surgery. Quality of daily life will be evaluated at 3, 6, and 12 months after surgery. Intention-to-treat analysis will also be conducted. The research protocol has been reviewed and approved by the Medical Thesis Committee of Henan Provincial Chest Hospital and Chest Hospital of Zhengzhou University on April 29, 2023 (reference: [2023] approval number: [04-06]). The results of this trial will be communicated to the participants and subsequently submitted for publication in peer-reviewed journals for wider dissemination. The study has been registered in the Chinese Clinical Trial Registry on June 27, 2023 (registration number: ChiCTR2300072869, available at https://www.chictr.org.cn/). The protocol version number is Version 1.1, dated August 20, 2023.