AnesthesiaPhase 2/3NCT05389813
Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia
A Phase 2/3 study testing Oxycodone 20 Mg Oral Tablet, Pregabalin 150mg and Multivitamin with Minerals in people with Anesthesia, run by An-Najah National University at 1 site in Palestinian Territories.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Oxycodone 20 Mg Oral Tablet, Pregabalin 150mg and Multivitamin with Minerals
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 15 Aug 2021to 1 May 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18-year-old.
- Patients undergoing elective surgeries under general anesthesia.
- American Society of Anesthesiology grade 1 or 2.
- BMI 18-35 Kg/m2
- Reliable participant (he/she can give history by him/herself)
Who cannot join
- Current Pregnancy or breastfeeding.
- Chronic use of analgesia (use of any analgesic drug for most days in the last three months).
- Current use of analgesia (within last 24 hours).
- Allergy to any medication used in the study.
- Smoking or Nargila use within last 24 hour before surgery and until discharge.
- History of psychiatric medication or disease.
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- Discharge from hospital within 6 hours after surgery.
- Participants transferred from the ward to ICU or other wards.
- Known case of liver or kidney impairment.
- History of alcohol use or illicit drug.
- Any complication during surgery leads to changes in protocol of the study.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
An-Najah National University Hospital
Nablus, Wes-Bank, 7704
About this study
Official title: Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia for Postoperative Pain Control, Placebo-controlled RCT, 2021
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:
Read more
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)
Read the detailed description
- After signing the informed consent, each participant will undergo standard care for any surgical patient (general examination, vital signs recording, history taking, and cannula insertion). Then, a nurse will teach him\her how to use the NRS for pain scores.
- Patients will be randomly allocated by computer-generated list to Group A (oxycodone 20 mg orally), Group B (pregabalin 150 mg orally), or Group C (multivitamins pill orally).
- The medication will be given 30 minutes before operation by an anesthesiology resident who is not aware of the study design in a closed envelope with a code similar to the file code of the participant and he will make sure that the participant ingests the pill with a sip of water and get rid of the envelope immediately.
- The participant then will be transferred to the preparation room before surgery, baseline scores will be recorded for the following parameter: pain scale (NRS) during rest and movement, Modified Ramsay Sedation Score (MRSS), and vital signs.
- Patient then will be transferred to the operation room, and induction of anaesthesia will begin.
The anaesthetic protocol will be standardized.
- The anaesthetists will record the duration of surgery as the time between induction of anaesthesia and arrival to Post-Anesthetic Care Unit (PACU). Arrival to PACU will be recorded as 0 times.
- The participant will be sent to the ward after collecting 8 points or greater or return to baseline on Post-Anesthesia Recovery Score (PARS). Time in PACU will be reported.
- A postoperative patient evaluation will be performed by an anaesthetist who will be unaware of the study design.
- Postoperative pain treatment will be with patient-controlled IV morphine 2.5 mg bolus (rescue analgesia). Nausea will be treated with ondansetron.
- Morphine consumption, pain intensity at rest and during mobilization, nausea and vomiting, sedation, dizziness, and consumption of ondansetron will be recorded at 0, 1, 4, and 8 h after operation.
- On discharge, time and date of discharge and satisfaction of analgesia score will be recorded.
- Conditions
- Anesthesia
- Being tested
- Oxycodone 20 Mg Oral Tablet, Pregabalin 150mg, Multivitamin with Minerals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone 20 Mg Oral TabletDrug
Also called Targin
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.
Pregabalin 150mgDrug
Also called Lyrica
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 MineralsDrug
Also called Abecedin
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.
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone | Active comparator | 20 mg oxycodone hydrochloride and 10 mg naloxone hydrochloride given as 1 tablet only once, 30 minutes preoperatively. Receives: Drug: Oxycodone 20 Mg Oral Tablet |
| Pregabalin | Active comparator | 150 mg Pregabalin given as 1 tablet only once, 30 minutes preoperatively. Receives: Drug: Pregabalin 150mg |
| Multivitamin | Placebo comparator | Abecedin Multivitamins\&Minerals given as 1 tablet only once, 30 minutes preoperatively. Receives: Drug: Multivitamin with Minerals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- NRS at rest.
- NRS at movement.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 8 hour postoperative
Secondary outcomes (10)
Sedation
Using the eight-point Modified Ramsay Sedation Score:
- Awake and alert, minimal or no cognitive impairment.
- Awake but tranquil, purposeful responses to verbal commands at a conversational level.
- Appears asleep, purposeful response to verbal commands at a conversational level.
- Appears asleep, purposeful responses to commands but at a louder than conversational level, requiring light glabellar tap, or both.
- Asleep, sluggish purposeful responses only to loud verbal commands, strong glabellar tap, or both.
- Asleep, sluggish purposeful responses only to painful stimuli.
- Asleep, reflex withdrawal to painful stimuli only
- Unresponsive to external stimuli, including pain
Measured: 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.
Measured: 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.
Measured: 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 ).
Measured: 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).
Measured: 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 (%).
Measured: 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.
Measured: 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?
- No(0-Score)
- Once or twice(2-Score)
- Three or more times(50-Score) Q2 Have you experienced a feeling of nausea (an unsettled feeling in the stomach and slight urge to vomit)? If yes. has your feeling of nausea interfered with activities of daily living? such as being able to get out of bed, being able to move about freely in bed, being able to walk normally or eating and drinking?
- 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:
- varying?(1-Score)
- constant?(2-Score) Q4 What was the duration of your feeling of nausea(in hours)? Where a score ≥50 defined clinically important PONV: PONV Intensity Scale=severity of nausea (1=mild, 2=moderate, 3=severe) × pattern of nausea (1=varying, 2=constant) × duration of nausea (in hours)
Measured: 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)
Measured: 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)
Measured: at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start15 Aug 2021
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- An-Najah National University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zaher Nazzal, Study director, An-Najah National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389813
- Sponsor's protocol ID
- Preemptive Analgesia
- Status last verified
- Jul 2023
- First submitted
- 15 Feb 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia for Postoperative Pain Control, Placebo-controlled RCT, 2021
- ClinicalTrials.gov ID
- NCT05389813
- Acronym / sponsor ID
- Preemptive Analgesia
- Conditions
- Anesthesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- An-Najah National UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
- After signing the informed consent, each participant will undergo standard care for any surgical patient (general examination, vital signs recording, history taking, and cannula insertion). Then, a nurse will teach him\her how to use the NRS for pain scores.
- Patients will be randomly allocated by computer-generated list to Group A (oxycodone 20 mg orally), Group B (pregabalin 150 mg orally), or Group C (multivitamins pill orally).
- The medication will be given 30 minutes before operation by an anesthesiology resident who is not aware of the study design in a closed envelope with a code similar to the file code of the participant and he will make sure that the participant ingests the pill with a sip of water and get rid of the envelope immediately.
- The participant then will be transferred to the preparation room before surgery, baseline scores will be recorded for the following parameter: pain scale (NRS) during rest and movement, Modified Ramsay Sedation Score (MRSS), and vital signs.
- Patient then will be transferred to the operation room, and induction of anaesthesia will begin.
The anaesthetic protocol will be standardized.
- The anaesthetists will record the duration of surgery as the time between induction of anaesthesia and arrival to Post-Anesthetic Care Unit (PACU). Arrival to PACU will be recorded as 0 times.
- The participant will be sent to the ward after collecting 8 points or greater or return to baseline on Post-Anesthesia Recovery Score (PARS). Time in PACU will be reported.
- A postoperative patient evaluation will be performed by an anaesthetist who will be unaware of the study design.
- Postoperative pain treatment will be with patient-controlled IV morphine 2.5 mg bolus (rescue analgesia). Nausea will be treated with ondansetron.
- Morphine consumption, pain intensity at rest and during mobilization, nausea and vomiting, sedation, dizziness, and consumption of ondansetron will be recorded at 0, 1, 4, and 8 h after operation.
- On discharge, time and date of discharge and satisfaction of analgesia score will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxycodone | Active comparator | Drug: Oxycodone 20 Mg Oral Tablet20 mg oxycodone hydrochloride and 10 mg naloxone hydrochloride given as 1 tablet only once, 30 minutes preoperatively. |
| Pregabalin | Active comparator | Drug: Pregabalin 150mg150 mg Pregabalin given as 1 tablet only once, 30 minutes preoperatively. |
| Multivitamin | Placebo comparator | Drug: Multivitamin with MineralsAbecedin Multivitamins\&Minerals given as 1 tablet only once, 30 minutes preoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18-year-old.
- Patients undergoing elective surgeries under general anesthesia.
- American Society of Anesthesiology grade 1 or 2.
- BMI 18-35 Kg/m2
- Reliable participant (he/she can give history by him/herself)
Key exclusion criteria (11 listed)
- Current Pregnancy or breastfeeding.
- Chronic use of analgesia (use of any analgesic drug for most days in the last three months).
- Current use of analgesia (within last 24 hours).
- Allergy to any medication used in the study.
- Smoking or Nargila use within last 24 hour before surgery and until discharge.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone 20 Mg Oral TabletAlso: TarginOxycodone 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. | Drug | Oxycodone |
| Pregabalin 150mgAlso: LyricaPregabalin 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. | Drug | Pregabalin |
| Multivitamin with MineralsAlso: AbecedinVit 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. | Drug | Multivitamin |
Primary outcome
Preoperative pain
Time frame: 30 minutes preoperative
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: * NRS at rest. * NRS at movement.
Postoperative pain
Time frame: at 0 hour postoperative
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.
Postoperative pain
Time frame: at 1 hour postoperative
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.
Postoperative pain
Time frame: at 4 hour postoperative
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.
Postoperative pain
Time frame: at 8 hour postoperative
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.
10 secondary outcomes
Sedation
Time frame: 30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.
Heart rate
Time frame: 30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.
Respiratory rate
Time frame: 30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.
Temperature
Time frame: 30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.
Blood pressure
Time frame: 30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.
O2 saturation
Time frame: 30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.
Drug side effects
Time frame: at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.
Postoperative nausea and vomiting
Time frame: At 6 hour postoperative
Rescue analgesia
Time frame: at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.
Antiemetics
Time frame: at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaher Nazzal study director
An-Najah National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oxycodone 20 Mg Oral Tablet, Pregabalin 150mg and Multivitamin with Minerals in people with Anesthesia, run by An-Najah National University at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative pain (time frame: 30 minutes preoperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.