Pregabalin and Analgesia After Laparoscopic Cholecystectomy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Preoperative Use of Pregabalin and Analgesia Levels After Laparoscopic Cholecystectomy|
- Postoperative pain [ Time Frame: Every 8 hours ] [ Designated as safety issue: No ]VAS = visual analoque scale 0-10 mm (0=no pain to 10= worst imaginable pain).Measured on the arrival of the patient to the recovery room(0 hrs), one hour later, and then every eight hours until the completion of 24 hours after operation.
- Side- effects [ Time Frame: 0,1, 8, 16 & 24 hours ] [ Designated as safety issue: Yes ]To determine the occurrence of side effects such as postoperative nausea,vomiting, itching, headache, dizziness, blurred vision, lack of concentration, shoulder pain, sedation, and respiratory depression.
- Postoperative opioid consumption [ Time Frame: 0,1, 8, 16 & 24 hour ] [ Designated as safety issue: No ]The total dose of morphine was calculated as mg and included opioids administered by PCA pump.On arrival in the PACU patients received morphine via PCA pump.Postoperative morphine requirements were assessed on the arrival of the patient to the recovery room (0 hrs), one hour later and then every eight hours, until the completion of 24 hours after operation.
|Study Start Date:||November 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Pregabalin
Preoperative administration of pregabalin 600mg to patients undergo laparoscopic cholecystectomy.Patients receive oral Pregabalin 300 mg the night before the surgery, and another one dose of 300 mg 1 hour prior to surgery
Preoperative administration of pregabalin 600mg
Other Name: Lyrica
Placebo Comparator: Placebo
Preoperative administration of placebo to patients undergo laparoscopic cholecystectomy.Patients receive oral Placebo the night before the surgery, and another one dose 1 hour prior to surgery.
Preoperative administration of a matching placebo
Acute pain frequently occurs during the postoperative period.Not treated acute postoperative pain may predict the development of chronic pain.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.
Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321801
|University Hospital of Larissa|
|Larissa, Greece, 41100|
|Principal Investigator:||Chamaidi Sarakatsianou, RN, MSc||University Hospital of Larissa|
|Study Chair:||George Tzovaras, MD||University Hospital of Larissa|
|Study Director:||Georgia Stamatiou, MD||University Hospital of Larissa|
|Study Chair:||Elena Theodorou, MD||University Hospital of Larissa|
|Study Chair:||Stavroula Georgopoulou, MD||University Hospital of Larissa|