Dataset Information

Effect of patient-controlled intravenous analgesia combined with flurbiprofen axetil and dezocine on postoperative analgesia for lobectomy (EPIC-FAD): a trial protocol.

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.

SUBMITTER: Zhou J

PROVIDER: S-EPMC7923454 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of patient-controlled intravenous analgesia combined with flurbiprofen axetil and dezocine on postoperative analgesia for lobectomy (EPIC-FAD): a trial protocol.

Zhou Jian J Pu Qiang Q Lin Lin L Chong Weelic W Chen Boran B Hai Yang Y Liu Fei F Liu Lunxu L

Trials 20210301 1

<h4>Background</h4>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.<h4>Methods</h4>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 sufe ...[more]

PMID: 33648558

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Project description:Background: Flurbiprofen axetil is a prodrug that releases the active substance through enzymatic removal of the ester moiety. It is formulated through encapsulation in a lipid microsphere carrier, and widely used to treat perioperative pain. Here, we studied the distribution of R (-)- and S (+)-flurbiprofen in human plasma and cerebrospinal fluid (CSF) after intravenous injection of flurbiprofen axetil. Methods: A total of 70 adult patients undergoing elective lower limb surgery under spinal anesthesia were given a single intravenous injection of 100-mg flurbiprofen axetil. The patients were randomly assigned to 10 groups for plasma and CSF sampling at 10 time points (5-50 min) after subarachnoid puncture and before actual spinal anesthesia. R (-)- and S (+)-flurbiprofen and CSF/plasma ratio were determined by liquid chromatography-tandem mass spectrometry. Results: R (-)-flurbiprofen concentration ranged from 2.01 to 10.9 μg/mL in plasma and 1.46-34.4 ng/mL in CSF. S (+)-flurbiprofen concentration ranged from 1.18 to 10.8 μg/mL in plasma and from 2.53 to 47 ng/mL in CSF. In comparison to S (+)-flurbiprofen, R (-)-flurbiprofen concentration was significantly higher in plasma at all time points (p < 0.05) except at 30 or 40 min, and lower in CSF at all time points (p < 0.05) except at 10, 15 and 40 min. Analysis after correcting drug concentration for body mass index also revealed higher plasma and lower CSF R (-)-flurbiprofen concentration. In comparison to S (+)-flurbiprofen, AUC0-50 for R (-)-flurbiprofen was larger in plasma and smaller in CSF (p < 0.05 for both), and accordingly smaller CSF/plasma AUC0-50 ratio (p < 0.05). There was a positive correlation between R (-)-flurbiprofen concentration and S (+)-flurbiprofen concentration in plasma (r = 0.725, p < 0.001) as well as in CSF (r = 0.718, p < 0.001), and a negative correlation between plasma and CSF concentration of S (+)-flurbiprofen (r = -0.250, p = 0.037), but not R (-)-flurbiprofen. Conclusion: Distribution of R (-)- and S (+)-flurbiprofen in plasma and CSF differed significantly. Penetration of R (-)-flurbiprofen into the CNS was lower than S (+)-flurbiprofen.

Project description:ObjectiveThe aim of this study was to systematically review the efficacy and safety of parecoxib and flurbiprofen axetil for perioperative analgesia in children through Bayesian network meta-analysis.MethodsWe systematically searched PubMed, Embase, Cochrane Library, Web of Science, Sinomed, CNKI, VIP, and Wanfang Data databases on 18 July 2022 to obtain randomized controlled trials comparing perioperative parecoxib or flurbiprofen with placebo or standard treatment for pediatric analgesia. The outcomes were the postoperative pain score and the incidence of adverse events. The Gemtc package of R-4.0.3 and Stata 17.0 were used for Bayesian network meta-analysis.ResultsWe retrieved 942 articles and 49 randomized controlled trials involving 3,657 patients who met the inclusion criteria. Compared with children who received placebo treatment, those who received flurbiprofen axetil had lower pain sores at each time point within 24 h postoperatively, and those who received parecoxib had lower pain sores at each time point within 12 h postoperatively. Compared with children who received tramadol treatment, both the children who received flurbiprofen axetil or parecoxib had lower pain scores at 8 h postoperatively. The ranking results demonstrated that flurbiprofen axetil had significant superiority in reducing pain scores at 2, 4, and 12 h postoperatively, and parecoxib had significant superiority in reducing pain scores at 0, 0.5, 1, 6, 8, and 24 h postoperatively. In terms of safety, compared with children who received placebo, those who received flurbiprofen axetil or parecoxib had a lower incidence of total adverse events and postoperative agitation. Compared with tramadol, flurbiprofen axetil and parecoxib both significantly reduced the incidence of total adverse events and postoperative nausea and vomiting. Compared with flurbiprofen axetil or fentanyl, parecoxib significantly reduced the incidence of postoperative nausea and vomiting. The ranking results showed that parecoxib was advantageous in decreasing the incidence of total adverse events and postoperative nausea and vomiting.ConclusionFlurbiprofen axetil was most effective at reducing pain scores at 2, 4, and 12 h postoperatively. Parecoxib had an advantage in terms of reducing pain scores at 0, 0.5, 1, 6, 8, and 24 h postoperatively, as well as the incidence of total adverse events and postoperative nausea and vomiting.Systematic trial registrationhttps://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=348886, PROSPERO (CRD42022348886).

Project description:The predictors of postoperative pain and analgesic consumption were previously found to include preoperative pain, anxiety, age, type of surgery, and genotype, but remaining unclear was whether intraoperative factors could predict postoperative pain. In the present study, we investigated the time-course of fentanyl consumption using intravenous patient-controlled analgesia records from patients who underwent orthognathic surgery for mandibular prognathism and analyzed the influence of anesthesia methods and surgical methods together with sex on the time course. A significant difference in the time course of fentanyl administration was found (P<0.001). No significant difference in the time course of fentanyl administration was found between males and females (P = 0.653), with no interaction between time course and sex (P = 0.567). No significant difference in the time course of fentanyl administration was found among anesthesia methods, such as fentanyl induction followed by fentanyl maintenance, fentanyl induction followed by remifentanil maintenance, and remifentanil induction followed by remifentanil maintenance (P = 0.512), but an interaction between time course and anesthesia method was observed (P = 0.004). A significant difference in the time course of fentanyl administration was found between surgical methods, such as bilateral mandibular sagittal split ramus osteotomy (BSSRO) and BSSRO combined with Le Fort I osteotomy (bimaxillary; P = 0.008), with no interaction between time course and surgical method (P = 0.535). Total postoperative 24 h consumption associated with the bimaxillary procedure was significantly higher than with BSSRO (P = 0.008). The present results indicate that administration patterns and total 24 h consumption were different among the three groups of anesthesia methods and between the two groups of surgical methods, respectively. Although more research on patient-controlled analgesia patterns and consumption is necessary, the present study will contribute to adequately relieving individual patients from postoperative pain.

Dataset Information

Effect of patient-controlled intravenous analgesia combined with flurbiprofen axetil and dezocine on postoperative analgesia for lobectomy (EPIC-FAD): a trial protocol.

Background

Methods

Discussion

Trial registration

Publications

Effect of patient-controlled intravenous analgesia combined with flurbiprofen axetil and dezocine on postoperative analgesia for lobectomy (EPIC-FAD): a trial protocol.

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