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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 pain

Side- 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

Page last updated: August 23, 2015

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