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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01940224
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
University of Thessaly
Information provided by (Responsible Party):
Elena Theodorou, Larissa University Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Pregabalin Drug: Placebo Drug: Morphine Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Preemptive Use of Pregabalin on Pain Intensity and Postoperative Morphine Consumption After Laparoscopic Colorectal Surgery
Study Start Date : July 2013
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pregabalin & Morphine
Administration of pregabalin 300 mg to patients undergo laparoscopic colorectal surgery.Patients receive oral Pregabalin 150 mg the night before surgery, and another one dose of 150 mg 1 hour prior to surgery. Postoperative administration of morphine via PCA pump for 48 hours
Drug: Pregabalin
Preoperative administration of pregabalin 300mg
Other Name: Lyrica

Drug: Morphine
Postoperative administration of morphine via PCA pump for 48h

Placebo Comparator: Placebo & Morphine
Administration of placebo to patients undergo laparoscopic colorectal surgery.Patients receive oral Placebo the night before surgery, and another one dose 1 hour prior to surgery.Postoperative administration of morphine via PCA pump for 48 hours
Drug: Placebo
Preoperative administration of placebo

Drug: Morphine
Postoperative administration of morphine via PCA pump for 48h




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940224


Locations
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Greece
University Hospital of Larissa
Larissa, Greece, 41100
Sponsors and Collaborators
Larissa University Hospital
University of Thessaly
Investigators
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Principal Investigator: Elena Theodorou, MD University Hospital of Larissa
Study Chair: George Tzovaras, MD, PhD University Hospital of Larissa
Study Director: Georgia Stamatiou, MD, PhD University Hospital of Larissa
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Responsible Party: Elena Theodorou, MD, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01940224    
Other Study ID Numbers: UTH2828/26/06/2013
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Keywords provided by Elena Theodorou, Larissa University Hospital:
Pregabalin
Laparoscopic colorectal surgery
Postoperative pain
Opioid consumption
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Pregabalin
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs