Combination of thoracic epidural analgesia with patient-controlled intravenous analgesia versus traditional thoracic epidural analgesia for postoperative analgesia and early recovery of laparotomy: a prospective single-centre, randomized controlled trial

This study was a single-centre prospective non-blinded randomised controlled trial (Chinese Clinical Trial Registry, ChiCTR 1,800,020,308, 13/12/2018). Ethical approval for this study (Ethical Committee No. [2018]265) was provided by the Ethics Committee of the First Affiliated Hospital of Sun Yat-Sen University. The study adhered to the CONSORT guidelines.

Participants

A total of 102 patients undergoing laparotomy in the First Affiliated Hospital of Sun Yat-Sen University were recruited between December 2018 and December 2019. The patients aged 18–75 years, with an ASA I or II, and BMI ranged from 18 to 27 kg m−2, who were undergoing laparotomy (hepatectomy, pancreaticoduodenectomy, gastrointestinal surgery, or colorectal surgery), were eligible for this study. Patients were randomly allocated to group TEA/PCIA or TEA according to a random number table by the Social Sciences software version 20.0 (SPSS Inc, Chicago, IL, USA). All participants must be able to understand the research protocol and signed informed consent. Exclusion criteria included contraindication to epidural analgesia, allergy or sensitivity to local anaesthetics, contraindication to opioid and non-opioid analgesic drugs. The patients with a history of chronic pain or long-time medication with antidepressants, narcotic analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) were also excluded.

Patients may discontinue participation in the trial at their own request, or be withdrawn if a surgery is not performed, or continuation of the trial may be detrimental to the patient’s health in the investigator’s opinion. Drop-out patients will be included in the final report to ensure complete transparency of the trial.

Preparations in the operation room before surgery

After established intravenous access and continuous monitoring in the operative room, the patients were placed in the lateral position to receive TEA prior to the induction of general anaesthesia. Insertion of an epidural catheter was performed between T8 and T10 in patients undergoing a right sided colon resection or upper abdominal surgery (hepatectomy, pancreaticoduodenectomy, gastrointestinal open surgery), or between T10 and T11 in patients undergoing a left sided colon resection. After the epidural space was identified using the loss of resistance technique with air, standard aseptic insertion procedure was performed. A test dose of 3 mL of 2% lidocaine was injected to ensure the catheter was in the correct space. Sterile device was used to hold the catheter in place after excluding the spinal anaesthesia.

Standard general anaesthesia

All patients in the trial underwent a general anaesthesia. Anaesthesia was induced with sufentanil (0.3–0.5 mcg kg−1), cisatracurium (0.2 mg kg−1) or rocuronium (0.6 mg kg−1), propofol (2–3 mg kg−1). Standard monitoring used in the surgery involved electrocardiogram, blood pressure, respiratory rate, oxygen saturation, end-tidal carbon dioxide, central venous pressure, temperature, and Narcotrend® (MonitorTechnik, Bad Bramstedt, Germany). Anaesthesia was maintained by propofol and sevoflurane, as the depth of anaesthesia showed as Narcotrend® value was kept between 40 and 60.

Intervention in TEA/PCIA group

Half an hour before the completion of surgery, 0.4 mg of hydromorphone 2 mL and 5 mL of 0.25% ropivacaine were injected into the epidural space as a loading dose. All the patients were then connected with an epidural analgesia pump (Jiangsu REHN Medical Instruments Technology CO., ITD). As for analgesia regimen, 0.125% ropivacaine combined with hydromorphone was used for TEA, with a background infusion rate of 2 mL h−1. TEA was only applied in the day of surgery and the first postoperative day. Hydromorphone combined with flurbiprofen was used for PCIA until third postoperative day. The removal time of an analgesia pump was recorded, and the cumulative opioid consumption was recorded in equivalents of oral morphine equivalents (OMEs) [11]. The types of medications and additional analgesics were documented in detail.

Intervention in TEA group

The patients in TEA group received epidural puncture and catheterization to establish epidural analgesia before anaesthesia induction. TEA was used until third postoperatively day. The analgesia regimen for TEA was the same as that in TEA/PCIA group, with the analgesia pump settings of a background infusion rate of 2 mL h−1. Similarly, detailed recording included removal time of an analgesia pump, cumulative opioid consumption, and additional analgesics.

Date collection

The demographic and operation-related information including age, sex, BMI, ASA grade, comorbidities, surgical type, incision type, and operation time was collected. Postoperative pain at rest and on movement was evaluated with visual analogue scale (VAS) pain score. The primary endpoints were mean VAS pain scores at rest and on movement for three days postoperatively. The secondary endpoints included VAS pain scores at rest and on movement at 6, 24, 48 and 72 h postoperatively, incidence of inadequate analgesia, incidence of opioid-related adverse events, the time to first mobilization, the time to pass first flatus, the time of oral intake recovery, the time of the urinary catheter removal, postoperative length of hospital stay (PLOS), cumulative opioid consumption, and overall cost.

Sample size

The mean VAS pain scores at rest and on movement for three days postoperatively were the primary endpoints in our work. Kelly et al.reported the minimum clinically significant VAS pain score in the management of severe pain was 1 cm [12]. Standard deviations (SD) varying between 1.4 and 1.8 cm have been reported, thus we estimated a SD of 1.5 cm for the study. To achieve 90% power to detect a difference (1 cm) in the primary endpoints with a two-sided 5% level of significance, a sample size of 38 patients in each group of the study is needed. An additional four participants were recruited in each study arm to cover a maximum of 10% losses, thus the sample size required for each group was up to 42 subjects.

Statistical analysis

SPSS software version 20.0 (SPSS Inc, Chicago, IL, USA) was used for statistical analysis. All numerical variables were first examined for normality. Numerical variables were descripted as mean ± SD for data with a normal distribution, otherwise descripted as median and interquartile range (IQR). Independent two-sample t-test was used for the comparison of the normally distributed numerical variables. The non-normally distributed numerical variables were compared by Mann–Whitney U test. Frequency and percentage were used for statistical description of categorical variables, and chi-square test or Fischer’s exact test were used for the comparison of the unordered categorical variables depend on their expected counts. Kruskal Wallis H test was used for ordinal multiple categorical variables. In addition, repeated measured data was analysed using repeated-measures analysis of variance (ANOVA), such as the VAS scores of the two groups at different time points. Bonferroni correction was used to adjust for the increased alpha error in the multiple comparisons. Survival analysis assessed by the Kaplan–Meier method and Breslow test was used to analyse postoperative indicators. P values < 0.05 was considered statistically significant (the level of significance was bilateral).

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