Analgesic Potentials of Preoperative Pregabalin,Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain

Postoperative Pain Clinical Trial

Official title:

Analgesic Potentials of Preoperative Oral Pregabalin,Intravenous Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain.(Randomized,Double-Blind Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678117
• Other study ID #: NCI,IRB 2010014053.3
• Status: Completed
• Phase: Phase 3
• Start date: July 2015
• Est. completion date: December 2019

Study information

• Verified date: September 2021
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 . 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. ASA status of1 or 2

2. Patients undergoing thoracotomy

3. Body mass index (BMI): Less than forty and more than twenty.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Pregabalin & Placebo

• Magnesium sulphate & Placebo

• Pregabalin & Magnesium sulphate

• Placebo

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Kiran 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption	patients are given regular intravenous morphine through patient controlled analgesia (PCA) and morphine consumption calculated from the PCA device	First 24 hours in postoperative period
Secondary	Pain intensity using Visual Analogue Scale	Assessment of pain intensity every 4 hours in the first 24 hours in postoperative period	First 24 hours in postoperative period
Secondary	Recovery Time	Time taken for recovery of the patient to be fully awake	Immediately after ending the surgery
Secondary	Heart Rate	Assessment of Heart Rate every 4 hours	First 24 hours in postoperative period
Secondary	Blood Pressure	Assessment of Blood Pressure every 4 hours	First 24 hours in postoperative period
Secondary	Oxygen saturation	Assessment of Oxygen saturation every 4 hours	First 24 hours in postoperative period
Secondary	Respiratory Rate	Assessment of Respiratory Rate every 4 hours	First 24 hours in postoperative period
Secondary	Postoperative nausea and vomiting	Postoperative nausea and vomiting scale (none 0, mild 1, moderate 2 , sever 3)	First 24 hours in postoperative period
Secondary	Side effects from the used drugs		First 24 hours in postoperative period
Secondary	Sedation score	Using Ramsay Sedation score	First 24 hours in postoperative period