Clinical Research Directory

Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.

Sponsor: National and Kapodistrian University of Athens

Summary

Introduction: Major abdominal surgery encompasses a broad range of surgical procedures in heterogeneous patient populations.Management of postoperative pain has received keen attention in recent years with considerable concurrent advancement in the field.Despite this improvement,postoperative pain continues to be a challenge since suboptimal postoperative pain control is a risk factor for persistent surgical pain,increased morbidity,poorer functional recovery and reduced quality of life.Therefore,analgesic strategies should regard patients' factors as well as surgical procedures peculiarities.Since efforts are made throughout the years and are of utmost importance as numerous analgesic options exist for the effective pain control after abdominal surgeries including multiple classes of drugs and routes of administration(i.e.parenteral,regional,neuraxia.)In the context of the current surgical environment where improvement has been made,emphasis is placed on precision,minimizing trauma and improving the outcome.The choice of postoperative pain analgesic modality,is at the discretion of the primary anaesthesiologist and the choice depends upon the plan favored by him/her as well as the availability of drugs and equipment.Continuous re-evaluation of analgesic strategies is a necessary step toward establishing a better pain management plan in major abdominal surgeries and to design guidelines to improve our clinical approach. Study Objective: The target of the study is to compare the outcome of the selected analgesic combination of local anaesthetic and opioid(ropivacaine+fentanyl or ropivacaine +morphine)for postoperative continuous infusion,aiming to relief successfully the pain,on patients undergoing major abdominal surgeries based on hemodynamic and clinical findings. The study aims to highlight the positive impact of the chosen analgesic combination during the intraoperative period,the postoperative recovery period and also during the follow up periods in terms of physical function,pain intensity during activity,adverse effects and self efficacy. Methods: The study is prospective,comparative aiming to identify the pain management agents that will provide the best postoperative relief in order to be established and used as a primary choice to patients undergoing major open abdominal surgeries .All patients included will receive the same analgesic technique(epidural)chosen preoperatively by the anaesthesiologist in charge.All study participants are informed in detail and written informed consent is obtained.The study is in accordance with the regulations of the Declaration of Helsinki on human studies and the Greek legislation. The investigators will study 58 patients,equally divided into two groups, aged 18-80 years,administered to Evangelismos General hospital,Athens-Greece, for elective open abdominal surgeries. In group A(p:29),the investigators will administer for postoperative pain relief - Ropivacaine 200 ml/400 mg + Fentanyl for continuous epidural infusion for the first 5 days.The infusion will start 2 hours before the end of the operation and before the admission to the intensive care unit. In group B(p:29),the investigators will administer for postoperative pain relief Ropivacaine 200ml/400mg + Morphine for continuous epidural infusion for the first 5 days.The infusion will start 2 hours before the end of the operation and before the admission to the intensive care unit.

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