Clinical trial NCT01321801: Pregabalin and Analgesia After Laparoscopic Cholecystectomy
Official title: Preoperative Use of Pregabalin and Analgesia Levels After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Postoperative
Keywords: Pregabalin
Laparoscopic cholecystectomy
Postoperative pain
Opioid consumption
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate how effective is the preoperative administration of pregabalin 600mg, to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II

Exclusion Criteria:

* Renal or hepatic insufficiency
* Alcohol or drugs abuse
* History of chronic pain or daily intake of analgesics
* Uncontrolled medical disease (hypertension, diabetes) and cardiovascular problems. 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

Primary outcomes:
measure: Postoperative pain
timeFrame: Every 8 hours
Secondary outcomes:
measure: Side- effects
timeFrame: 0,1, 8, 16 & 24 hours
measure: Postoperative opioid consumption
timeFrame: 0,1, 8, 16 & 24 hour
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa
Study officials:
affiliation: University Hospital of Larissa
name: Chamaidi Sarakatsianou, RN, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Larissa
name: George Tzovaras, MD
role: STUDY_CHAIR
affiliation: University Hospital of Larissa
name: Georgia Stamatiou, MD
role: STUDY_DIRECTOR
affiliation: University Hospital of Larissa
name: Elena Theodorou, MD
role: STUDY_CHAIR
affiliation: University Hospital of Larissa
name: Stavroula Georgopoulou, MD
role: STUDY_CHAIR
References:
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