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NCT Number: NCT02678117

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

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Cancer Institute

Cairo, 11796, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA status of1 or 2
  • Patients undergoing thoracotomy
  • 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.
  • Significant liver or kidney diseases that will affects the pharmacokinetics of study drugs.

Treatment and study plan

Pregabalin & Placebo

Drug

Magnesium sulphate & Placebo

Drug

Pregabalin & Magnesium sulphate

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

Analgesic Potentials of Preoperative Oral Pregabalin,Intravenous Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain.(Randomized,Double-Blind Study)

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 9, 2016
Registry last updated
Sep 22, 2021

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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