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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin & placebo | Active Comparator | : will receive single dose oral Pregabalin 300 mg one hour preoperative and 200 ml of normal saline over 20 min. |
|
| Magnesium sulphate & Placebo | Active Comparator | 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. |
|
| Pregabalin & Magnesium sulphate | Active Comparator | : 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. |
|
| Placebo | Placebo Comparator | will receive placebo medications at the same time and route of administration of other groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin & Placebo | Drug |
| ||
| Magnesium sulphate & Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine consumption | patients are given regular intravenous morphine through patient controlled analgesia (PCA) and morphine consumption calculated from the PCA device | First 24 hours in postoperative period |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity using Visual Analogue Scale | Assessment of pain intensity every 4 hours in the first 24 hours in postoperative period | First 24 hours in postoperative period |
| Recovery Time | Time taken for recovery of the patient to be fully awake |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Naglaa A Ahmed, MD | National Cancer Institute (NCI) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute | Cairo | 11796 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23524696 | Background | Sagit M, Yalcin S, Polat H, Korkmaz F, Cetinkaya S, Somdas MA. Efficacy of a single preoperative dose of pregabalin for postoperative pain after septoplasty. J Craniofac Surg. 2013 Mar;24(2):373-5. doi: 10.1097/SCS.0b013e31827fece5. | |
| 21431050 | Background | Kiran S, Gupta R, Verma D. Evaluation of a single-dose of intravenous magnesium sulphate for prevention of postoperative pain after inguinal surgery. Indian J Anaesth. 2011 Jan;55(1):31-5. doi: 10.4103/0019-5049.76605. |
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De-identified individual participant data for all primary and secondary outcome measures will be available within 6 months of study completion
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| Drug |
|
| Pregabalin & Magnesium sulphate | Drug |
|
| Placebo | Drug |
|
| Immediately after ending the surgery |
| Heart Rate | Assessment of Heart Rate every 4 hours | First 24 hours in postoperative period |
| Blood Pressure | Assessment of Blood Pressure every 4 hours | First 24 hours in postoperative period |
| Oxygen saturation | Assessment of Oxygen saturation every 4 hours | First 24 hours in postoperative period |
| Respiratory Rate | Assessment of Respiratory Rate every 4 hours | First 24 hours in postoperative period |
| Postoperative nausea and vomiting | Postoperative nausea and vomiting scale (none 0, mild 1, moderate 2 , sever 3) | First 24 hours in postoperative period |
| Side effects from the used drugs | First 24 hours in postoperative period |
| Sedation score | Using Ramsay Sedation score | First 24 hours in postoperative period |
| 30730476 | Derived | Salah Abdelgalil A, Shoukry AA, Kamel MA, Heikal AMY, Ahmed NA. Analgesic Potentials of Preoperative Oral Pregabalin, Intravenous Magnesium Sulfate, and their Combination in Acute Postthoracotomy Pain. Clin J Pain. 2019 Mar;35(3):247-251. doi: 10.1097/AJP.0000000000000673. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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