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The research will be conducted between March 2021 and June 2023. All patients scheduled electively for one of four surgeries (Laparoscopic Cholecystectomy, Submucosal resection, Breast lumpectomy, and median laparotomy) at that period of time at An-Najah National University hospital will be included in the research sample, unless not meeting with the criteria put.
Primary objectives are:
To evaluate the effectiveness of preemptive analgesia on postoperative pain relief and shorter hospital stay for adults undergoing surgical procedures, according to the type of surgery and the type of drug.
To compare the effect of a single oral preemptive dose of Pregabalin versus Oxycodone on postoperative pain relief, in terms of pain intensity as assessed by pain numeric rating scale (NRS)
The anaesthetic protocol will be standardized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone | Active Comparator | 20 mg oxycodone hydrochloride and 10 mg naloxone hydrochloride given as 1 tablet only once, 30 minutes preoperatively. |
|
| Pregabalin | Active Comparator | 150 mg Pregabalin given as 1 tablet only once, 30 minutes preoperatively. |
|
| Multivitamin | Placebo Comparator | Abecedin Multivitamins&Minerals given as 1 tablet only once, 30 minutes preoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone 20 Mg Oral Tablet | Drug | Oxycodone is a semi-synthetic, morphine-like opioid alkaloid with analgesic activity. Oxycodone exerts its analgesic activity by binding to the mu-receptors in the central nervous system (CNS), thereby mimicking the effects of endogenous opioids. Binding of the opiate receptor stimulates the exchange of GTP for GDP on the G-protein complex and inhibits adenylate cyclase, thereby preventing cAMP production. Subsequently, the release of nociceptive neurotransmitters, such as substance P, gamma-aminobutyric acid (GABA), dopamine, acetylcholine, and noradrenaline, is inhibited. Oxycodone also inhibits the release of vasopressin, somatostatin, insulin, and glucagon. In addition, oxycodone closes N-type voltage-gated calcium channels and opens G-protein-coupled inwardly rectifying potassium channels resulting in hyperpolarization and reduction of neuronal excitability. |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative pain | The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), has become the most widely used instrument for pain screening. This will have 2 contents:
| 30 minutes preoperative |
| Postoperative pain | The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), has become the most widely used instrument for pain screening. | at 0 hour postoperative |
| Postoperative pain | The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), has become the most widely used instrument for pain screening. | at 1 hour postoperative |
| Postoperative pain | The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), has become the most widely used instrument for pain screening. | at 4 hour postoperative |
| Postoperative pain | The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), has become the most widely used instrument for pain screening. | at 8 hour postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation | Using the eight-point Modified Ramsay Sedation Score:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zaher Nazzal | An-Najah National University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| An-Najah National University Hospital | Nablus | Wes-Bank | 7704 | Palestinian Territories |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D013607 | Tablets |
| D000069583 | Pregabalin |
| C067316 | Geritol |
| D008903 | Minerals |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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|
|
| Pregabalin 150mg | Drug | Pregabalin is a gabapentinoid and acts by inhibiting certain calcium channels. Specifically it is a ligand of the auxiliary α2δ subunit site of certain voltage-dependent calcium channels (VDCCs), and thereby acts as an inhibitor of α2δ subunit-containing VDCCs. There are two drug-binding α2δ subunits, α2δ-1 and α2δ-2, and pregabalin shows similar affinity for (and hence lack of selectivity between) these two sites. Pregabalin is selective in its binding to the α2δ VDCC subunit. Despite the fact that pregabalin is a GABA analogue. r synthesizing GABA, and hence may have some indirect GABAergic effects by increasing GABA levels in the brain. In accordance, inhibition of α2δ-1-containing VDCCs by pregabalin appears to be responsible for its anticonvulsant, analgesic, and anxiolytic effects. |
|
|
| Multivitamin with Minerals | Drug | Vit A 3000 IU, Vit B1 2.5mg, Vit B2 2.0mg, Vit B12 10mcg, Vit C 150mg, Vit D3 400 IU, Vit E10 IU, Biotin 25mcg, Nicotimamide 30mg, Calcium Pantothenate 3mg, Folic acid 800mcg, Iron Fumarate 18mg, Calcium 125mg, Magnesium Oxide 10mg, Iodine Potassium 150mcg, Manganese sulfate 0.5mg, Phosphorus 23.8mg, Copper sulfate 1.0mg, Molybdinium Sodium 0.10mg, Zinc Sulfate 5.0mg. |
|
|
| 30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative. |
| Heart rate | it will be measured by pulse oximeter and expressed as beats per minute. | 30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative. |
| Respiratory rate | it will be measured by counting the number of breaths for one minute by counting how many times the chest rises and expressed as breaths per minute. | 30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative. |
| Temperature | it will be measured by thermometer and expressed in degrees Celsius ( °C ). | 30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative. |
| Blood pressure | Systolic and diastolic blood pressure will be measured by sphygmomanometer and expressed in millimeters of mercury (mmHg). | 30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative. |
| O2 saturation | it will be measured by pulse oximeter and expressed as percent (%). | 30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative. |
| Drug side effects | Measuring the incidence of undesirable effect of a drug (constipation, respiratory depression, diarrhea, headache, dyspepsia, itching, urinary retention, and pruritus) using a questionnaire with Yes or No answer. | at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative. |
| Postoperative nausea and vomiting | Postoperative nausea and vomiting intensity scale Q1 Have you vomited or had dry-retching?
a) No(0-Score) b) Sometimes(1-Score) c) Often or most of the time(2-Score) d) All of the time(25-Score) Q3 Has your nausea been mostly:
| At 6 hour postoperative |
| Rescue analgesia | Time to first use of rescue analgesia (which is 3 my IV Morphine) and Total analgesic consumption (mg/kg) | at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative. |
| Antiemetics | Time to first use of antiemetics (which is 4 mg IV Ondansetrone) and Total analgesic consumption (mg/kg) | at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative. |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| 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 |
| D007287 | Inorganic Chemicals |