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Analgesic Potentials of Preoperative Pregabalin,Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain

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ClinicalTrials.gov Identifier: NCT02678117
Recruitment Status : Unknown
Verified August 2018 by Ahmed Salah Ahmed Abd Elgalil, National Cancer Institute, Egypt.
Recruitment status was:  Recruiting
First Posted : February 9, 2016
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Salah Ahmed Abd Elgalil, National Cancer Institute, Egypt

Brief Summary:
This study evaluates the effect of giving preoperative adjuvant drug as pregabalin or magnesium sulphate or a combination of both drugs to decrease postoperative morphine consumption and pain intensity in the first 24 hours in postoperative period . quarter of patients receive single dose oral pregabalin 300mg 1 hour preoperatively ,other quarter receive single intravenous Magnesium sulphate 50mg per Kg over 200ml saline over 20 minutes preoperatively , other quarter receive combination of both drugs , the last quarter receive placebo drugs . All patients receive 0.1mg per Kg intravenous morphine sulphate intraoperatively

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Pregabalin & Placebo Drug: Magnesium sulphate & Placebo Drug: Pregabalin & Magnesium sulphate Drug: Placebo Phase 3

Detailed Description:

Magnesium (Mg) acts on N-methyl-D-aspartate (NMDA) receptor as a non-competitive antagonist with antinociceptive effects.

Gabapentin is an alkylated analogue of gammaaminobutyric acid (GABA) developed primarily as an anticonvulsant drug. It was described as an analgesic drug for the treatment of neuropathic pain in the 1990s. Although it is named Gabapentin,it does not bind at the GABA A or GABA B receptor. It binds with high affinity for the α2δ subunit of the presynaptic voltage-gated calcium channels, which reduce calcium-dependent release of pro-nociceptive neurotransmitters in the pain pathways. Pregabalin is a structural analogue of GABA was introduced after Gabapentin. If we used these drugs in combination to opioids preoperatively as preventive analgesia may decrease postoperative opioid consumption and pain intensity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Analgesic Potentials of Preoperative Oral Pregabalin,Intravenous Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain.(Randomized,Double-Blind Study)
Actual Study Start Date : July 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pregabalin & placebo
: will receive single dose oral Pregabalin 300 mg one hour preoperative and 200 ml of normal saline over 20 min.
Drug: Pregabalin & Placebo
Active Comparator: Magnesium sulphate & Placebo
will receive preoperative single dose IV Magnesium Sulphate 50mg /kg infused over 20 minutes diluted in 200 ml normal saline and a placebo capsule similar to pregabalin 300 mg.
Drug: Magnesium sulphate & Placebo
Active Comparator: Pregabalin & Magnesium sulphate
: will receive single dose oral pregabalin 300mg one hour preoperative and single dose IV Magnesium Sulphate 50mg /kg infused over 20 minutes diluted in 200 ml normal saline.
Drug: Pregabalin & Magnesium sulphate
Placebo Comparator: Placebo
will receive placebo medications at the same time and route of administration of other groups.
Drug: Placebo



Primary Outcome Measures :
  1. Total morphine consumption [ Time Frame: First 24 hours in postoperative period ]
    patients are given regular intravenous morphine through patient controlled analgesia (PCA) and morphine consumption calculated from the PCA device


Secondary Outcome Measures :
  1. Pain intensity using Visual Analogue Scale [ Time Frame: First 24 hours in postoperative period ]
    Assessment of pain intensity every 4 hours in the first 24 hours in postoperative period

  2. Recovery Time [ Time Frame: Immediately after ending the surgery ]
    Time taken for recovery of the patient to be fully awake

  3. Heart Rate [ Time Frame: First 24 hours in postoperative period ]
    Assessment of Heart Rate every 4 hours

  4. Blood Pressure [ Time Frame: First 24 hours in postoperative period ]
    Assessment of Blood Pressure every 4 hours

  5. Oxygen saturation [ Time Frame: First 24 hours in postoperative period ]
    Assessment of Oxygen saturation every 4 hours

  6. Respiratory Rate [ Time Frame: First 24 hours in postoperative period ]
    Assessment of Respiratory Rate every 4 hours

  7. Postoperative nausea and vomiting [ Time Frame: First 24 hours in postoperative period ]
    Postoperative nausea and vomiting scale (none 0, mild 1, moderate 2 , sever 3)

  8. Side effects from the used drugs [ Time Frame: First 24 hours in postoperative period ]
  9. Sedation score [ Time Frame: First 24 hours in postoperative period ]
    Using Ramsay Sedation score



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ASA status of1 or 2
  2. Patients undergoing thoracotomy
  3. Body mass index (BMI): Less than forty and more than twenty.

Exclusion Criteria:

- 1. Known sensitivity or contraindication to drugs used in the study. 2. History of psychological disorders and/or chronic pain. 3. Patients receiving medical therapies that are considered to result in tolerance to opioids.

4. Significant liver or kidney diseases that will affects the pharmacokinetics of study drugs.


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): NCT02678117


Contacts
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Contact: Ahmed S Ahmed +20 01098426689 Dr_mido12@yahoo.com
Contact: Ashraf M Heikal, MD +2001226564878 ashrafyheikal@gmail.com

Locations
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Egypt
National Cancer Institute Recruiting
Cairo, Egypt, 11796
Contact: Ahmed S Ahmed    +20 01098426689    Dr_mido12@yahoo.com   
Sponsors and Collaborators
National Cancer Institute, Egypt
Investigators
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Study Chair: Naglaa A Ahmed, MD National Cancer Institute (NCI)
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahmed Salah Ahmed Abd Elgalil, Demonstrator in anaesthesia department, National Cancer Institute, Egypt, National Cancer Institute, Egypt
ClinicalTrials.gov Identifier: NCT02678117    
Other Study ID Numbers: NCI,IRB 2010014053.3
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be available within 6 months of study completion
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Magnesium Sulfate
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anesthetics
Anti-Arrhythmia Agents
Tocolytic Agents
Reproductive Control Agents