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NCT Number: NCT01321801

Pregabalin and Analgesia After Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Pain Postoperative Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Larissa

Larissa, 41100, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

Preoperative administration of pregabalin 600mg

Other names: Lyrica

Placebo

Drug

Preoperative administration of a matching placebo

Primary outcomes

  1. Postoperative pain

    Time frame: Every 8 hours

    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.

Secondary outcomes

  1. Side- effects

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

    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.

  2. Postoperative opioid consumption

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

    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.

Sponsors and collaborators

Lead sponsor

Larissa University Hospital

Other

Registry information

Official study title

Preoperative Use of Pregabalin and Analgesia Levels After Laparoscopic Cholecystectomy

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 24, 2011
Registry last updated
Jan 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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