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Remifentanil versus fentanyl during cardiac surgery on the incidence of chronic thoracic pain (REFLECT): study protocol for a randomized controlled trial.

ABSTRACT: Chronic thoracic pain after cardiac surgery is prevalent (11 to 56%) and may affect patients' physical and mental health status. Despite its favorable pharmacokinetic and pharmacodynamic properties, high doses of remifentanil administered during surgery are reported to cause acute postoperative pain and increased requirements for analgesics. Recently, an association between remifentanil use and the incidence of chronic thoracic pain in the long term was also reported. Our objective is to investigate the influence of the intraoperative remifentanil on chronic postoperative pain in a prospective randomized controlled trial.In this prospective, randomized, single-blind clinical trial, all patients (N = 126) between 18 and 85 years undergoing cardiac surgery via sternotomy receive a continuous infusion of propofol together with intermittent intravenous fentanyl at predetermined times perioperatively. Patients are randomized to receive either an additional continuous infusion of remifentanil (0.15 ?g(-1)kgIBW(-1) min(-1)) or additional fentanyl (200 to 500 ?g) as needed during surgery.The primary end point is the prevalence of chronic thoracic pain 12 months after surgery. Secondary end points include acute postoperative pain; postoperative analgesic use; chronic thoracic pain 3 and 6 months after surgery; quality of life (SF-12) at 3, 6 and 12 months after surgery; work productivity; and use of health care. In addition, thermal detection and pain thresholds are measured preoperatively, 3 days after surgery and 12 months after surgery using quantitative sensory testing (QST). Finally, the influence of several genetic variances on the different outcomes will be measured.Chronic thoracic pain is prevalent after cardiac surgery, and research is needed to minimize the risk of chronic persistent postoperative pain, which is an invalidating, long-term complication of surgery. The objective of this trial is to determine the influence of perioperative remifentanil on long-term pain outcomes for cardiac patients in a prospective randomized trial. The results may be used to optimize perioperative analgesia techniques and, thereby, improve quality of life after cardiac surgery.Clinicaltrials.gov NCT02031016 on 13 December 2013.

SUBMITTER: de Hoogd S

PROVIDER: S-EPMC4258928 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Remifentanil versus fentanyl during cardiac surgery on the incidence of chronic thoracic pain (REFLECT): study protocol for a randomized controlled trial.

de Hoogd Sjoerd S Ahlers Sabine J G M SJ van Dongen Eric P A EP Tibboel Dick D Dahan Albert A Knibbe Catherijne A J CA

Trials 20141127

<h4>Background</h4>Chronic thoracic pain after cardiac surgery is prevalent (11 to 56%) and may affect patients' physical and mental health status. Despite its favorable pharmacokinetic and pharmacodynamic properties, high doses of remifentanil administered during surgery are reported to cause acute postoperative pain and increased requirements for analgesics. Recently, an association between remifentanil use and the incidence of chronic thoracic pain in the long term was also reported. Our obje ...[more]

PMID: 25429720

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Project description:ObjectivesOur Enhanced Recovery After Thoracic Surgery protocol was implemented on February 1, 2018, and firmly established 7 months later. We instituted protocol modifications on January 1, 2020, aiming to further reduce postoperative opioid consumption. We sought to evaluate the influence of such efforts on clinical outcomes and the use of both schedule II and schedule IV opioids following robotic thoracoscopic procedures.MethodsA retrospective study of patients undergoing elective robotic procedures between September 1, 2018, and December 31, 2020, was conducted. Essential components of pain management in the original protocol included nonopioid analgesics, intercostal nerve blocks with long-acting liposomal bupivacaine diluted with normal saline, and opioids (ie, scheduled tramadol administration and as-needed schedule II narcotics). Protocol optimization included replacing saline diluent with 0.25% bupivacaine and switching tramadol to as needed, keeping other aspects unchanged. Demographic characteristics, type of robotic procedures, postoperative outcomes, and in-hospital and postdischarge opioids prescribed (ie, milligrams of morphine equivalent [MME]) were extracted from electronic medical records.ResultsThree hundred twenty-four patients met the inclusion criteria (159 in the original and 183 in the optimized protocol). There was no difference in postoperative outcomes or acute postoperative pain; there was a significant reduction of in-hospital and postdischarge opioid requirements in the optimized cohort. For anatomic resections: mean, 60.0 MME (range, 0-60.0 MME) versus mean, 105.0 MME (range, 60.0-150.0 MME), and other procedures: mean, 0 MME (range, 0-60 MME) versus mean, 140.0 (range, 60.0-150.0 MME) (P < .00001) with median schedule II opioids prescribed = 0.ConclusionsSmall modifications to our protocol for pain management strategies are safe and associated with significant decrease of opioid requirements, particularly schedule II narcotics, during the postoperative period without influencing acute pain levels.

Project description:BackgroundThe clinical relevance of the suggested hyperalgesic effects of remifentanil is still unclear, especially in the long term.ObjectiveThe current study evaluated the impact of remifentanil on thermal thresholds 3 days and 12 months after surgery, measured with Quantitative Sensory Testing.DesignA single-blind, randomised controlled trial.SettingA tertiary care teaching hospital in The Netherlands, from 2014 to 2016.PatientsA total of 126 patients aged between 18 and 85 years, undergoing cardiothoracic surgery via sternotomy (coronary artery bypass grafts and/or valve replacement) were included. Exclusion criteria were BMI above 35 kg m, history of cardiac surgery, chronic pain conditions, neurological conditions, allergy to opioids or paracetamol, language barrier and pregnancy.InterventionsPatients were allocated randomly to receive intra-operatively either a continuous remifentanil infusion or intermittent intra-operative fentanyl as needed in addition to standardised anaesthesia with propofol and intermittent intravenous fentanyl at predetermined time points.Main outcome measuresWarm and cold detection and pain thresholds 3 days and 12 months after surgery. In addition the use of remifentanil, presence of postoperative chronic pain, age, opioid consumption and pre-operative quality of life were tested as a predictor for altered pain sensitivity 12 months after surgery.ResultsBoth warm and cold detection, and pain thresholds, were not significantly different between the remifentanil and fentanyl groups 3 days and 12 months after surgery (P > 0.05). No significant predictors for altered pain sensitivity were identified.ConclusionEarlier reports of increased pain sensitivity 1 year after the use of remifentanil could not be confirmed in this randomised study using Quantitative Sensory Testing. This indicates that remifentanil plays a minor role in the development of chronic thoracic pain. Still, the relatively high incidence of chronic thoracic pain and its accompanying impact on quality of life remain challenging problems.Trial registrationThe study was registered at EudraCT (ref: 2013-000201-23) and ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02031016).

Dataset Information

Remifentanil versus fentanyl during cardiac surgery on the incidence of chronic thoracic pain (REFLECT): study protocol for a randomized controlled trial.

Publications

Remifentanil versus fentanyl during cardiac surgery on the incidence of chronic thoracic pain (REFLECT): study protocol for a randomized controlled trial.

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