Postoperative Pain
Conditions
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
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.
Interventions
DRUGPregabalin & Placebo
DRUGMagnesium sulphate & Placebo
DRUGPregabalin & Magnesium sulphate
DRUGPlacebo
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption | 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
| Measure | Time frame | Description |
|---|---|---|
| Recovery Time | Immediately after ending the surgery | Time taken for recovery of the patient to be fully awake |
| Heart Rate | First 24 hours in postoperative period | Assessment of Heart Rate every 4 hours |
| Blood Pressure | First 24 hours in postoperative period | Assessment of Blood Pressure every 4 hours |
| Oxygen saturation | First 24 hours in postoperative period | Assessment of Oxygen saturation every 4 hours |
| Pain intensity using Visual Analogue Scale | First 24 hours in postoperative period | Assessment of pain intensity every 4 hours in the first 24 hours in postoperative period |
| Postoperative nausea and vomiting | First 24 hours in postoperative period | Postoperative nausea and vomiting scale (none 0, mild 1, moderate 2 , sever 3) |
| Side effects from the used drugs | First 24 hours in postoperative period | — |
| Sedation score | First 24 hours in postoperative period | Using Ramsay Sedation score |
| Respiratory Rate | First 24 hours in postoperative period | Assessment of Respiratory Rate every 4 hours |
Countries
Egypt
Outcome results
None listed