Clinical Trials Logo

Clinical Trial Summary

Number of patients with unsatisfactory pain relief defined as average visual analog scale (VAS) more than 5 with or without requirement of IVPCA for pain relief during the first 48 hours postoperative period will be compared between the two groups and form the primary outcome for the study. Postoperative pain intensity will be measured by Visual Analog Scale (VAS) with 0- being no pain and 10-being maximum pain and the analgesic efficacy in both groups will also be evaluated by the amount of total narcotic consumption (measured with IV morphine equivalent doses of analgesics used to provide pain relief).

Clinical Trial Description

In response to an increased focus on improving patient outcomes and satisfaction with surgical care, a growing body of clinical evidence has recently been dedicated to enhanced recovery after surgery (ERAS) protocols. These evidence-based perioperative pathways aim to optimize patients undergoing surgery in the preoperative, intraoperative, and postoperative periods. ERAS protocols have incorporated the use of multimodal analgesia to minimize the use of intra- and postoperative opioid analgesics. Lidocaine, ketamine, magnesium, gabapentin, acetaminophen and non-steroidal anti-inflammatory drugs are some of the adjuvant analgesics used in combination with regional blocks to optimize analgesia and recovery. Multimodal analgesia has dependably been shown to significantly reduce postoperative opioid requirements as well as opioid-related side effects such as postoperative nausea and vomiting. Both oral and intravenous acetaminophen preparations have been shown to be useful adjuvants in multimodal analgesia. Intravenous acetaminophen has been of interest for its utility in post-surgical patients, who have not yet been cleared for oral intake. Intravenous acetaminophen should also be preferred over oral acetaminophen in patients after major abdominal surgery where absorption of medications given through oral route is erratic. Although the efficacy of intravenous acetaminophen as a postoperative pain adjunct is known, its exact role in ERAS protocols and non-narcotic multimodal analgesic regimens for major abdominal surgery has not been studied in randomized clinical trials to define its efficacy. The primary goal of this study is to assess the utility of a postoperative intravenous acetaminophen dosing schedule in minimizing postoperative pain, opioid consumption and opioid-related side effects. We also aim to study overall patient satisfaction and cost-effectiveness (direct and indirect costs) of this regimen as part of ERAS protocol at a large tertiary medical center. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03198871
Study type Interventional
Source University of Pittsburgh
Contact Amy Monroe
Phone 412-623-6382
Status Recruiting
Phase Phase 4
Start date May 24, 2018
Completion date August 15, 2019

See also
  Status Clinical Trial Phase
Completed NCT02916199 - Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method N/A
Recruiting NCT02971579 - A Register on the Quality of ERCP and Training of Endoscopists in Italy N/A
Not yet recruiting NCT01900938 - Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During ERCP N/A
Enrolling by invitation NCT03234543 - Remote Ischemic Conditioning in Abdominal Surgery N/A
Not yet recruiting NCT03717298 - Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma Phase 2
Recruiting NCT03334708 - A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
Completed NCT01427725 - Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency N/A
Completed NCT02337673 - Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography N/A
Active, not recruiting NCT01964430 - Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study) Phase 3
Recruiting NCT03074708 - Application of 3D Visualization and 3D Printing in the Hepatobiliary and Pancreatic Surgery N/A
Recruiting NCT02739074 - Effectiveness of Metal Protheses Covered in "Diabolo" in Treatment of Necrosis of Origin Pancreatic: Trial "DIABOLOPIG" N/A
Completed NCT01832116 - 89Zr-MMOT PET Imaging in Pancreatic and Ovarian Cancer Patients Phase 1
Recruiting NCT03535727 - A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer Phase 1/Phase 2
Recruiting NCT02471170 - Protocol to Permit the Acquisition of Circulating Tumor Material in Pancreatic Diseases
Completed NCT01350037 - Alfentanil Versus Remifentanil in Patient-controlled Sedation During Endoscopic Retrograde Cholangiopancreatography (ERCP) Phase 4
Recruiting NCT03400280 - POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection N/A
Enrolling by invitation NCT03578770 - Safety and Efficacy of the New 20 mm Lumen Apposing Metal Stent (Lams) for Endoscopic Treatment of Pancreatic and Peripancreatic Fluid Collections N/A
Recruiting NCT03267355 - Indications and Outcomes of Endoscopic Ultrasound in Tanta N/A
Terminated NCT00040131 - Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED) Phase 2
Recruiting NCT03398941 - The Effect of Preoperative Long Period Octreotide Combined With Postoperative Short Period Octreotide on the Complications After Pancreatectomy. A Prospective, Multicenter Clinical Trial N/A