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

Phase 3

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Magnesium sulphate & Placebo; Drug: Pregabalin & Magnesium sulphate; Drug: Pregabalin & Placebo; Drug: Placebo

• Registration Number: NCT02678117
• Lead Sponsor: National Cancer Institute, Egypt

Brief 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

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-06
• Study First Posted: 2016-02-09
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium sulphate & Placebo	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.
Pregabalin & Magnesium sulphate	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.
Pregabalin & placebo	Pregabalin & Placebo	: will receive single dose oral Pregabalin 300 mg one hour preoperative and 200 ml of normal saline over 20 min.
Placebo	Placebo	will receive placebo medications at the same time and route of administration of other groups.

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	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

Secondary Outcome Measures

Name	Time	Method
Pain intensity using Visual Analogue Scale	First 24 hours in postoperative period	Assessment of pain intensity every 4 hours in the first 24 hours in postoperative period
Heart Rate	First 24 hours in postoperative period	Assessment of Heart Rate every 4 hours
Blood Pressure	First 24 hours in postoperative period	Assessment of Blood Pressure every 4 hours
Oxygen saturation	First 24 hours in postoperative period	Assessment of Oxygen saturation every 4 hours
Respiratory Rate	First 24 hours in postoperative period	Assessment of Respiratory Rate every 4 hours
Recovery Time	Immediately after ending the surgery	Time taken for recovery of the patient to be fully awake
Postoperative nausea and vomiting	First 24 hours in postoperative period	Postoperative nausea and vomiting scale (none 0, mild 1, moderate 2 , sever 3)
Sedation score	First 24 hours in postoperative period	Using Ramsay Sedation score
Side effects from the used drugs	First 24 hours in postoperative period

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Egypt