Jian Zhou1,2, Qiang Pu1,2, Lin Lin1, Weelic Chong3, Boran Chen2, Yang Hai1,3, Fei Liu4, Lunxu Liu5,6,7. 1. Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, No. 37, Guoxue Alley, Chengdu, 610041, Sichuan, China. 2. West China School of Medicine, Sichuan University, Chengdu, China. 3. Sidney Kimmel School of Medicine, Thomas Jefferson University, Philadelphia, PA, USA. 4. Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China. 5. Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, No. 37, Guoxue Alley, Chengdu, 610041, Sichuan, China. lunxu_liu@aliyun.com. 6. West China School of Medicine, Sichuan University, Chengdu, China. lunxu_liu@aliyun.com. 7. Western China Collaborative Innovation Center for Early Diagnosis and Multidisciplinary Therapy of Lung Cancer, Sichuan University, Chengdu, China. lunxu_liu@aliyun.com.
Abstract
BACKGROUND: The optimal analgesic strategy for surgical pain after lobectomy remains undefined. To compare the combination of flurbiprofen axetil and dezocine with flurbiprofen axetil alone and dezocine alone, in post-lobectomy patients. METHODS: A single-center, parallel-design double-blind superiority trial, with 5 groups (1:1:1:1:1 ratio) with different combinations of flurbiprofen and dezocine. Patients scheduled for lobectomy will be recruited. The primary outcome is total sufentanil use in patient-controlled intravenous analgesia within the first 24 postoperative hours. Secondary outcomes include pain numeric rating scales at 6th, 12th, 24th, 48th, and 72th postoperative hours, and on the 1st, 3rd, and 6th postoperative months at rest and during coughing, adverse effects from experimental drug treatment, sufentanil use at other time points, analgesia cost, time to chest tube removal, length of hospital stay, time to pass first flatus, and serum level of cytokines. Doctors, patients, and nurses are blinded, and only the manager is unblinded. Analysis is intention-to-treat. Statistical analysis is pre-specified. Statistical comparison of the treatment groups includes one-way analysis of variance followed by Tukey's post hoc test. DISCUSSION: Trial did not begin to recruit. Participant recruitment start date is planned to be June 1, 2020. Approximate recruitment end date is May 31, 2021. If successful, the trial may shed light on the use of certain analgesic combinations in post-lobectomy pain control. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1800018563 . Registered on September 25, 2018.
RCT Entities:
BACKGROUND: The optimal analgesic strategy for surgical pain after lobectomy remains undefined. To compare the combination of flurbiprofen axetil and dezocine with flurbiprofen axetil alone and dezocine alone, in post-lobectomy patients. METHODS: A single-center, parallel-design double-blind superiority trial, with 5 groups (1:1:1:1:1 ratio) with different combinations of flurbiprofen and dezocine. Patients scheduled for lobectomy will be recruited. The primary outcome is total sufentanil use in patient-controlled intravenous analgesia within the first 24 postoperative hours. Secondary outcomes include pain numeric rating scales at 6th, 12th, 24th, 48th, and 72th postoperative hours, and on the 1st, 3rd, and 6th postoperative months at rest and during coughing, adverse effects from experimental drug treatment, sufentanil use at other time points, analgesia cost, time to chest tube removal, length of hospital stay, time to pass first flatus, and serum level of cytokines. Doctors, patients, and nurses are blinded, and only the manager is unblinded. Analysis is intention-to-treat. Statistical analysis is pre-specified. Statistical comparison of the treatment groups includes one-way analysis of variance followed by Tukey's post hoc test. DISCUSSION: Trial did not begin to recruit. Participant recruitment start date is planned to be June 1, 2020. Approximate recruitment end date is May 31, 2021. If successful, the trial may shed light on the use of certain analgesic combinations in post-lobectomy pain control. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1800018563 . Registered on September 25, 2018.
Authors: Annabel Sandra Mueller-Stierlin; Friedrich Meixner; Anne Kohlmann; Mara Schumacher; Anke Hänsel; Melanie Pouwels; Nicole Bias; Sabrina Hartl; Jessica Reichstein; Elke Prestin; Nils Greve; Thomas Becker; Reinhold Kilian Journal: Trials Date: 2020-06-30 Impact factor: 2.279
Authors: Thomas G de Leeuw; Laura Mangiarini; Rebecca Lundin; Florentia Kaguelidou; Tjitske van der Zanden; Oscar Della Pasqua; Dick Tibboel; Adriana Ceci; Saskia N de Wildt Journal: Trials Date: 2019-01-15 Impact factor: 2.279