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

NCT02678117 | Completed Phase 3

• 1 other identifier: NCI,IRB 2010014053.3
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pain intensity using Visual Analogue Scale

  First 24 hours in postoperative period

• Recovery Time

  Immediately after ending the surgery

• Heart Rate

  First 24 hours in postoperative period

• Blood Pressure

  First 24 hours in postoperative period

• Oxygen saturation

  First 24 hours in postoperative period

Study Arms (4)

Pregabalin & placebo

ACTIVE COMPARATOR

: will receive single dose oral Pregabalin 300 mg one hour preoperative and 200 ml of normal saline over 20 min.

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.

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.

Drug: Pregabalin & Magnesium sulphate

Placebo

PLACEBO COMPARATOR

will receive placebo medications at the same time and route of administration of other groups.

Drug: Placebo

Interventions

Pregabalin & Placebo DRUG

Pregabalin & placebo

Magnesium sulphate & Placebo DRUG

Magnesium sulphate & Placebo

Pregabalin & Magnesium sulphate DRUG

Pregabalin & Magnesium sulphate

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA status of1 or 2
• Patients undergoing thoracotomy
• Body mass index (BMI): Less than forty and more than twenty.

You may not qualify if:

• \- 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.
• \. Significant liver or kidney diseases that will affects the pharmacokinetics of study drugs.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

Location

Related Publications (3)

• 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.

  PMID: 23524696 BACKGROUND

• 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.

  PMID: 21431050 BACKGROUND

• Salah 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.

  PMID: 30730476 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Naglaa A Ahmed, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator in anaesthesia department, National Cancer Institute, Egypt

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 9, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)