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Completed

NCT Number: NCT01940224

Evaluation of Preoperative Use of Pregabalin on Postoperative Analgesia After Laparoscopic Colorectal Surgery

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

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Key information

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

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pregabalin

Drug

Preoperative administration of pregabalin 300mg

Other names: Lyrica

Placebo

Drug

Preoperative administration of placebo

Morphine

Drug

Postoperative administration of morphine via PCA pump for 48h

Primary outcomes

  1. Postoperative opioid consumption

    Time frame: 48 hours

    The total dose of morphine was calculated as mg and administered by PCA pump. Postoperative morphine requirements were assessed on the arrival of the patient to the recovery room (0hrs),8 hrs,24 hrs until the completion of 48 hours after operation.

Secondary outcomes

  1. Postoperative pain

    Time frame: 48 hours

    NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain)

  2. Side- effects

    Time frame: 48 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

  3. Hospital stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

Sponsors and collaborators

Lead sponsor

Larissa University Hospital

Other

Collaborators

  • University of Thessaly

Registry information

Official study title

Effectiveness of Preemptive Use of Pregabalin on Pain Intensity and Postoperative Morphine Consumption After Laparoscopic Colorectal Surgery

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2013
Registry last updated
Feb 27, 2019

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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