Opioid UsePhase 3NCT05539924
Pregabalin Versus Gabapentin Opioid Sparing Effect in Discectomy
A Phase 3 study testing Pregabalin 150mg gabapentin 400mg in people with Opioid Use, run by Research Institute of Ophthalmology, Egypt at 1 site in Egypt.
Trial summary
Pregabalin and gabapentin are both GABA analogue and their mechanism of action is not fully understood. Both drugs when given as a pre-emptive analgesia for spinal surgery were found to reduce intra-and postoperative opioid requirements. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use
- What is being tested?
- Pregabalin 150mg gabapentin 400mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2022to 1 Nov 2022
- Phase
- Phase 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I and ASA II
- Elective Lumber micro discectomy.
- BMI ≤ 35
- Time of operation not exceeding 2hours.
Who cannot join
- Patients' refusal
- Age < 20 years or > 60 years
- ASA III to ASA IV
- Contraindications to Opioids e.g., Allergy, Bronchial asthma.
- Contraindication to Pregabalin or Gabapentin e.g. Allergy
- Psychological or mental disorders.
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- Disturbance of Conscious level.
- Uncooperative patients.
- Patients with impaired renal function or creatinine clearance less than 50ml/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Pregabalin and Gabapentin as Adjuvants to Opioids in Elective Lumber Micro Discectomy to Control Postoperative Pain. (A Prospective Randomized Controlled Study)
Pregabalin and gabapentin are both GABA analogue and their mechanism of action is not fully understood. Both drugs when given as a pre-emptive analgesia for spinal surgery were found to reduce intra-and postoperative opioid requirements.
Preoperative intramuscular injection of morphine could reduce the patients' pain during the percutaneous transformational endoscopic discectomy "PTED" surgery and improve the patients' satisfaction without affecting the surgical outcome. The efficacy of adding pregabalin or gabapentin to preoperative intramuscular morphine is not yet investigated.
The current study aims to compare the analgesic effect of both drugs when given preoperatively with intramuscular morphine.
Read the detailed description
Preoperative assessment will be conducted on the patients that will be enrolled in this study including history taking, Physical examination, and laboratory investigations and radiological investigations; according to the medical condition of the patients. All patients must fulfill the inclusion criteria then the patients are consented to be included in the study \& informed about the required fasting hours.
Informed consent will be obtained from the entire patient enrolled in this study on the day before surgery. VAS score will be explained to all the patients' Visual analogue scale to measure post-operative pain.
VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end.
The patient marks on the line the point that they feel represents their perception of their current state. On the day of surgery, study drug was given orally 1 hour before the time of induction of anesthesia.
In the operation theatre, baseline heart rate, oxygen saturation, and mean arterial blood pressure were recorded. After insertion of a wide bore cannula, and premeditations will be given including anxiolytics e.g. midazolam (70-80mcg/kg) not to exceed >5mg and Ondansteron (4mg)
Then the patients will be randomized into one of the following three groups:
Group P: The patients in this group will receive 150 mg pregabalin tablets P.O 1 hour before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly.
Group G: The patients in this group will receive 400 mg Gababentin4 tablets P.O 1 hour before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly.
Group C: The patients in this group will receive vitamin B12(100µg) as placebo tablets P.O 1 hour before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly.
The patients enrolled in the study will be transferred to Operation room and monitored all through the surgical procedure using pulse oximeter, non-invasive blood pressure, ECG, capnogram. Patient will be preoxygenated with 100% oxygen for 3 minutes prior to induction. Induction of Anaesthesia will be done using propofol (2mg/kg), Fentanyl (1mcg/kg) and Atracrium (0.5 mg/kg) then Endotracheal intubation will be inserted smoothly using Oral ETT (ID 7.5mm in adult male and ID 7 mm in adult female) then position of Endotracheal tube will be confirmed with auscultation and Capnography.
Anaesthesia will be maintained using 1.2 % isoflurane (that will be adjusted according to hemodynamics changes) with top up doses of atracurium (0.1 mg/kg) every 30 minutes.
Ventilation will be maintained using volume controlled mode with the following parameters:
Tidal volumes 6-8 ml/kg, Respiratory Rate 12 breath/minute to achieve end tidal CO2 between 30 to 35 mmHg.
Intraoperative hemodynamics including heart rate, blood pressure (Systolic, Diastolic and Mean Arterial pressure) will be measured as baseline before induction, after ¼ hour from intubation, before and after the patient being in prone position and every ½ hour.
The patient will be positioned in prone position and precautions of this position will be applied, if Intraoperative hemodynamic changes happened more than 20% or 25% from baseline hemodynamic readings due to lack of analgesia, we will administer(0.5-1 mic.) Fentanyl as rescue analgesia.
At the End of the operation the patient will be returned to supine position and awaked fully reversed with injection of neostigmine and Atropine, and the patients will be extubated and shifted to Recovery room and we will check hemodynamics including heart rate and systolic, diastolic, mean arterial blood pressure, assess VAS scale and requirement of rescue analgesia (morphine) in zero hour then the patients will be transferred to the ward and reassess hemodynamics, the VAS scale and requirement of rescue analgesia after two hours, four hours, six hours, eight hours, ten hours, twelve hours, sixteen hours, twenty hours and twenty four hours respectively.
Postoperative pain assessment through VAS will be according to the scale as follow:
- Pain level 0: no pain
- Pain level1-3: mild pain
- Pain level 4-6: moderate pain
- Pain level 7-10: severe pain
- Postoperative pain will be managed as follow:
- Mild pain will be treated with paracetamol 1 gm. IV.
- Moderate pain will be treated with paracetamol 1 gm. IV \& ketolac 30 mg IV.
- Severe pain will be treated with morphine 3mg (rescue analgesia). Then patient will be reassessed and recorded as mentioned above and the specific treatment will be repeated after 8 hours from the initial dose according to VAS.
- Opioids complications such as respiratory depression will be recorded and managed supportively by oxygen mask, controlled airway and if persistent or severe hypoventilation occurs positive pressure ventilation may be needed, nausea and vomiting will be treated with ondansterone (4 mg IV).
- Conditions
- Opioid Use
- Being tested
- Pregabalin 150mg gabapentin 400mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mg gabapentin 400mgDrug
Also called vitamin B12
oral administration
| Study group | Role | What they receive |
|---|---|---|
| Group P | Active comparator | The patients in this group will receive 150 mg pregabalin tablets P.O 1 hours before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly. Receives: Drug: Pregabalin 150mg gabapentin 400mg |
| Group G | Active comparator | The patients in this group will receive 400 mg Gababentin4 tablets P.O 1 hours before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly. Receives: Drug: Pregabalin 150mg gabapentin 400mg |
| Group C | Placebo comparator | The patients in this group will receive vitamin B12 (100µg) as placebo tablets P.O hours before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly. Receives: Drug: Pregabalin 150mg gabapentin 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first rescue analgesia during the first postoperative 24 hours.
call for analgesia
Measured: 24 hours
Secondary outcomes (1)
pain score
VAS
Measured: 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start15 Sep 2022
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Institute of Ophthalmology, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor
- Investigators
- mohamed s arafa, MD, Study director, kasr el aini H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539924
- Sponsor's protocol ID
- 00arafa00
- Status last verified
- Oct 2022
- First submitted
- 10 Sep 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Pregabalin and Gabapentin as Adjuvants to Opioids in Elective Lumber Micro Discectomy to Control Postoperative Pain. (A Prospective Randomized Controlled Study)
- ClinicalTrials.gov ID
- NCT05539924
- Acronym / sponsor ID
- 00arafa00
- Conditions
- Opioid Use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Research Institute of Ophthalmology, EgyptUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 14 Sep 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.
Pregabalin and gabapentin are both GABA analogue and their mechanism of action is not fully understood. Both drugs when given as a pre-emptive analgesia for spinal surgery were found to reduce intra-and postoperative opioid requirements.
Preoperative intramuscular injection of morphine could reduce the patients' pain during the percutaneous transformational endoscopic discectomy "PTED" surgery and improve the patients' satisfaction without affecting the surgical outcome. The efficacy of adding pregabalin or gabapentin to preoperative intramuscular morphine is not yet investigated.
The current study aims to compare the analgesic effect of both drugs when given preoperatively with intramuscular morphine.
Detailed description
Preoperative assessment will be conducted on the patients that will be enrolled in this study including history taking, Physical examination, and laboratory investigations and radiological investigations; according to the medical condition of the patients. All patients must fulfill the inclusion criteria then the patients are consented to be included in the study \& informed about the required fasting hours.
Informed consent will be obtained from the entire patient enrolled in this study on the day before surgery. VAS score will be explained to all the patients' Visual analogue scale to measure post-operative pain.
VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end.
The patient marks on the line the point that they feel represents their perception of their current state. On the day of surgery, study drug was given orally 1 hour before the time of induction of anesthesia.
In the operation theatre, baseline heart rate, oxygen saturation, and mean arterial blood pressure were recorded. After insertion of a wide bore cannula, and premeditations will be given including anxiolytics e.g. midazolam (70-80mcg/kg) not to exceed >5mg and Ondansteron (4mg)
Then the patients will be randomized into one of the following three groups:
Group P: The patients in this group will receive 150 mg pregabalin tablets P.O 1 hour before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly.
Group G: The patients in this group will receive 400 mg Gababentin4 tablets P.O 1 hour before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly.
Group C: The patients in this group will receive vitamin B12(100µg) as placebo tablets P.O 1 hour before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly.
The patients enrolled in the study will be transferred to Operation room and monitored all through the surgical procedure using pulse oximeter, non-invasive blood pressure, ECG, capnogram. Patient will be preoxygenated with 100% oxygen for 3 minutes prior to induction. Induction of Anaesthesia will be done using propofol (2mg/kg), Fentanyl (1mcg/kg) and Atracrium (0.5 mg/kg) then Endotracheal intubation will be inserted smoothly using Oral ETT (ID 7.5mm in adult male and ID 7 mm in adult female) then position of Endotracheal tube will be confirmed with auscultation and Capnography.
Anaesthesia will be maintained using 1.2 % isoflurane (that will be adjusted according to hemodynamics changes) with top up doses of atracurium (0.1 mg/kg) every 30 minutes.
Ventilation will be maintained using volume controlled mode with the following parameters:
Tidal volumes 6-8 ml/kg, Respiratory Rate 12 breath/minute to achieve end tidal CO2 between 30 to 35 mmHg.
Intraoperative hemodynamics including heart rate, blood pressure (Systolic, Diastolic and Mean Arterial pressure) will be measured as baseline before induction, after ¼ hour from intubation, before and after the patient being in prone position and every ½ hour.
The patient will be positioned in prone position and precautions of this position will be applied, if Intraoperative hemodynamic changes happened more than 20% or 25% from baseline hemodynamic readings due to lack of analgesia, we will administer(0.5-1 mic.) Fentanyl as rescue analgesia.
At the End of the operation the patient will be returned to supine position and awaked fully reversed with injection of neostigmine and Atropine, and the patients will be extubated and shifted to Recovery room and we will check hemodynamics including heart rate and systolic, diastolic, mean arterial blood pressure, assess VAS scale and requirement of rescue analgesia (morphine) in zero hour then the patients will be transferred to the ward and reassess hemodynamics, the VAS scale and requirement of rescue analgesia after two hours, four hours, six hours, eight hours, ten hours, twelve hours, sixteen hours, twenty hours and twenty four hours respectively.
Postoperative pain assessment through VAS will be according to the scale as follow:
- Pain level 0: no pain
- Pain level1-3: mild pain
- Pain level 4-6: moderate pain
- Pain level 7-10: severe pain
- Postoperative pain will be managed as follow:
- Mild pain will be treated with paracetamol 1 gm. IV.
- Moderate pain will be treated with paracetamol 1 gm. IV \& ketolac 30 mg IV.
- Severe pain will be treated with morphine 3mg (rescue analgesia). Then patient will be reassessed and recorded as mentioned above and the specific treatment will be repeated after 8 hours from the initial dose according to VAS.
- Opioids complications such as respiratory depression will be recorded and managed supportively by oxygen mask, controlled airway and if persistent or severe hypoventilation occurs positive pressure ventilation may be needed, nausea and vomiting will be treated with ondansterone (4 mg IV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group P | Active comparator | Drug: Pregabalin 150mg gabapentin 400mgThe patients in this group will receive 150 mg pregabalin tablets P.O 1 hours before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly. |
| Group G | Active comparator | Drug: Pregabalin 150mg gabapentin 400mgThe patients in this group will receive 400 mg Gababentin4 tablets P.O 1 hours before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly. |
| Group C | Placebo comparator | Drug: Pregabalin 150mg gabapentin 400mgThe patients in this group will receive vitamin B12 (100µg) as placebo tablets P.O hours before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I and ASA II
Key exclusion criteria (9 listed)
- Patients' refusal
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 |
|---|---|---|
| Pregabalin 150mg gabapentin 400mgAlso: vitamin B12oral administration | Drug | Group C, Group G, Group P |
Primary outcome
time to first rescue analgesia during the first postoperative 24 hours.
Time frame: 24 hours
call for analgesia
1 secondary outcome
pain score
Time frame: 24 hours post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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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.
mohamed s arafa, MD study director
kasr el aini H
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin 150mg gabapentin 400mg in people with Opioid Use, run by Research Institute of Ophthalmology, Egypt at 1 site in Egypt.
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 4 inclusion and 9 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 27 Oct 2022. 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 Egypt. 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 phase mean?
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?
time to first rescue analgesia during the first postoperative 24 hours. (time frame: 24 hours). 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 27 Oct 2022.