Pregabalin and Analgesia After Laparoscopic Cholecystectomy

Larissa University Hospital50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Pain Postoperative

Interventions

PregabalinDRUG

Preoperative administration of pregabalin 600mg

placeboDRUG

Preoperative administration of a matching placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Larissa

Larissa, Greece

Outcomes

Primary Outcomes

Postoperative pain

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.

Time frame: Every 8 hours

Secondary Outcomes

Side- effects

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.

Time frame: 0,1, 8, 16 & 24 hours

Postoperative opioid consumption

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.

Time frame: 0,1, 8, 16 & 24 hour

Data from ClinicalTrials.gov

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