Analgesic Potentials of Preoperative Pregabalin,Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain
|ClinicalTrials.gov Identifier: NCT02678117|
Recruitment Status : Unknown
Verified August 2018 by Ahmed Salah Ahmed Abd Elgalil, National Cancer Institute, Egypt.
Recruitment status was: Recruiting
First Posted : February 9, 2016
Last Update Posted : August 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Pregabalin & Placebo Drug: Magnesium sulphate & Placebo Drug: Pregabalin & Magnesium sulphate Drug: Placebo||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Analgesic Potentials of Preoperative Oral Pregabalin,Intravenous Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain.(Randomized,Double-Blind Study)|
|Actual Study Start Date :||July 2015|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||February 2019|
Active Comparator: Pregabalin & placebo
: will receive single dose oral Pregabalin 300 mg one hour preoperative and 200 ml of normal saline over 20 min.
Drug: Pregabalin & Placebo
Active Comparator: Magnesium sulphate & Placebo
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.
Drug: Magnesium sulphate & Placebo
Active Comparator: 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.
Drug: Pregabalin & Magnesium sulphate
Placebo Comparator: Placebo
will receive placebo medications at the same time and route of administration of other groups.
- 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
- Pain intensity using Visual Analogue Scale [ Time Frame: First 24 hours in postoperative period ]Assessment of pain intensity every 4 hours in the first 24 hours in postoperative period
- Recovery Time [ Time Frame: Immediately after ending the surgery ]Time taken for recovery of the patient to be fully awake
- Heart Rate [ Time Frame: First 24 hours in postoperative period ]Assessment of Heart Rate every 4 hours
- Blood Pressure [ Time Frame: First 24 hours in postoperative period ]Assessment of Blood Pressure every 4 hours
- Oxygen saturation [ Time Frame: First 24 hours in postoperative period ]Assessment of Oxygen saturation every 4 hours
- Respiratory Rate [ Time Frame: First 24 hours in postoperative period ]Assessment of Respiratory Rate every 4 hours
- Postoperative nausea and vomiting [ Time Frame: 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 [ Time Frame: First 24 hours in postoperative period ]
- Sedation score [ Time Frame: First 24 hours in postoperative period ]Using Ramsay Sedation score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678117
|Contact: Ahmed S Ahmed||+20 01098426689||Dr_mido12@yahoo.com|
|Contact: Ashraf M Heikal, MDfirstname.lastname@example.org|
|National Cancer Institute||Recruiting|
|Cairo, Egypt, 11796|
|Contact: Ahmed S Ahmed +20 01098426689 Dr_mido12@yahoo.com|
|Study Chair:||Naglaa A Ahmed, MD||National Cancer Institute (NCI)|