Postoperative PainPhase 3NCT02678117
Analgesic Potentials of Preoperative Pregabalin,Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain
A Phase 3 study testing Pregabalin & Magnesium sulphate in people with Postoperative Pain, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pregabalin & Magnesium sulphate
- 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
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2015to Dec 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA status of1 or 2
- Patients undergoing thoracotomy
- Body mass index (BMI): Less than forty and more than twenty.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Potentials of Preoperative Oral Pregabalin,Intravenous Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain.(Randomized,Double-Blind Study)
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
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Pregabalin & Placebo, Magnesium sulphate & Placebo, Pregabalin & Magnesium sulphate, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin & PlaceboDrug
Magnesium sulphate & PlaceboDrug
Pregabalin & Magnesium sulphateDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin & placebo | Active comparator | : will receive single dose oral Pregabalin 300 mg one hour preoperative and 200 ml of normal saline over 20 min. Receives: Drug: Pregabalin & Placebo |
| 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. Receives: Drug: Magnesium sulphate & Placebo |
| 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. Receives: Drug: Pregabalin & Magnesium sulphate |
| Placebo | Placebo comparator | will receive placebo medications at the same time and route of administration of other groups. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
patients are given regular intravenous morphine through patient controlled analgesia (PCA) and morphine consumption calculated from the PCA device
Measured: First 24 hours in postoperative period
Secondary outcomes (9)
Pain intensity using Visual Analogue Scale
Assessment of pain intensity every 4 hours in the first 24 hours in postoperative period
Measured: First 24 hours in postoperative period
Recovery Time
Time taken for recovery of the patient to be fully awake
Measured: Immediately after ending the surgery
Heart Rate
Assessment of Heart Rate every 4 hours
Measured: First 24 hours in postoperative period
Blood Pressure
Assessment of Blood Pressure every 4 hours
Measured: First 24 hours in postoperative period
Oxygen saturation
Assessment of Oxygen saturation every 4 hours
Measured: First 24 hours in postoperative period
Respiratory Rate
Assessment of Respiratory Rate every 4 hours
Measured: First 24 hours in postoperative period
Postoperative nausea and vomiting
Postoperative nausea and vomiting scale (none 0, mild 1, moderate 2 , sever 3)
Measured: First 24 hours in postoperative period
Side effects from the used drugs
Measured: First 24 hours in postoperative period
Sedation score
Using Ramsay Sedation score
Measured: First 24 hours in postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salah Ahmed Abd Elgalil, National Cancer Institute, Egypt
- Investigators
- Naglaa A Ahmed, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678117
- Sponsor's protocol ID
- NCI,IRB 2010014053.3
- Status last verified
- Sep 2021
- First submitted
- 5 Feb 2016
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be available within 6 months of study completion
Publications
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.
PubMed 23524696Kiran 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.
PubMed 21431050Salah 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.
PubMed 30730476
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Potentials of Preoperative Oral Pregabalin,Intravenous Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain.(Randomized,Double-Blind Study)
- ClinicalTrials.gov ID
- NCT02678117
- Acronym / sponsor ID
- NCI,IRB 2010014053.3
- Conditions
- Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 9 Feb 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregabalin & placebo | Active comparator | Drug: Pregabalin & Placebo: 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 | Drug: Magnesium sulphate & Placebowill 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 | Drug: Pregabalin & Magnesium sulphate: 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 | Drug: Placebowill receive placebo medications at the same time and route of administration of other groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA status of1 or 2
- Patients undergoing thoracotomy
- Body mass index (BMI): Less than forty and more than twenty.
Key exclusion criteria (2 listed)
- 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.
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 & Placebo | Drug | Pregabalin & placebo |
| Magnesium sulphate & Placebo | Drug | Magnesium sulphate & Placebo |
| Pregabalin & Magnesium sulphate | Drug | Pregabalin & Magnesium sulphate |
| Placebo | Drug | Placebo |
Primary outcome
Total morphine consumption
Time frame: 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
9 secondary outcomes
Pain intensity using Visual Analogue Scale
Time frame: First 24 hours in postoperative period
Recovery Time
Time frame: Immediately after ending the surgery
Heart Rate
Time frame: First 24 hours in postoperative period
Blood Pressure
Time frame: First 24 hours in postoperative period
Oxygen saturation
Time frame: First 24 hours in postoperative period
Respiratory Rate
Time frame: First 24 hours in postoperative period
Postoperative nausea and vomiting
Time frame: First 24 hours in postoperative period
Side effects from the used drugs
Time frame: First 24 hours in postoperative period
Sedation score
Time frame: First 24 hours in postoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Background: PubMed 23524696Sagit 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.
- Background: PubMed 21431050Kiran 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.
- Derived from this study: PubMed 30730476Salah 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.
- Individual participant dataSharing planned: Yes. 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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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.
Naglaa A Ahmed, MD study chair
National Cancer Institute (NCI)
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 & Magnesium sulphate in people with Postoperative Pain, run by National Cancer Institute, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 22 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total morphine consumption (time frame: First 24 hours in postoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02678117, which also lists 3 linked publications.
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 22 Sep 2021.