Evaluation of Preoperative Use of Pregabalin on Postoperative Analgesia After Laparoscopic Colorectal Surgery
Information source: Larissa University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Pregabalin (Drug); Placebo (Drug); Morphine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Larissa University Hospital Official(s) and/or principal investigator(s): Elena Theodorou, MD, Principal Investigator, Affiliation: University Hospital of Larissa George Tzovaras, MD, PhD, Study Chair, Affiliation: University Hospital of Larissa Georgia Stamatiou, MD, PhD, Study Director, Affiliation: University Hospital of Larissa
Overall contact: George Tzovaras, MD,PhD, Phone: +302413502730, Email: gtzovaras@hotmail.com
Summary
The purpose of this study is to evaluate how effective is the preoperative administration of
pregabalin 300mg, to attenuate postoperative pain and opioids consumption after laparoscopic
colorectal surgery
Clinical Details
Official title: Effectiveness of Preemptive Use of Pregabalin on Pain Intensity and Postoperative Morphine Consumption After Laparoscopic Colorectal Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Postoperative opioid consumption
Secondary outcome: Postoperative painSide- effects Chronic Pain Hospital stay
Detailed description:
Laparoscopic colorectal surgery has gained wide acceptance because it is associated with
reduced pain, lower morbidity, faster recovery and a shorter hospital stay. However, the
optimal postoperative pain management method for patients undergoing laparoscopic colorectal
surgery is still under evaluation and most of the recommendations are based on studies
performed in open approach procedures.
Recently, the analgesic effect of pregabalin, as a part of a multimodal analgesia, has been
evaluated in many studies. They have shown that pregabalin may have a role in the post
operative pain management, as an adjunct. Pregabalin is an anticonvulsant and anxiolytic
drug, which have a more favorable pharmacokinetic profile from its predecessor gabapentin.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- ASA physical status I-III
- Patients who undergo laparoscopic colectomy for benign or malignant colorectal
disease ( <Τ3 or =T3 tumors without distant metastasis )
Exclusion Criteria:
- Contraindication for pneumoperitoneum
- Contraindication for laparoscopic approach
- Renal or hepatic insufficiency
- Alcohol or drugs abuse
- History of chronic pain or daily intake of analgesics
- Psychiatric disorders
- Inability of patients to use PCA pump History of intake of non-steroidal
anti-inflammatory drugs the last 24 hours before surgery,use of drainage after the
surgery
Locations and Contacts
George Tzovaras, MD,PhD, Phone: +302413502730, Email: gtzovaras@hotmail.com
University Hospital of Larissa, Larissa 41100, Greece; Recruiting George Tzovaras, MD,PhD, Phone: +302413502730, Email: gtzovaras@hotmail.com Elena Theodorou, MD, Phone: +3024103501370, Email: man.lena@gmail.com Elena Theodorou, MD, Principal Investigator Chamaidi Sarakatsianou, RN, MSc, Sub-Investigator Stavroula Georgopoulou, MD, Sub-Investigator
Additional Information
Starting date: July 2013
Last updated: March 31, 2015
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