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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Pregabalin & Placebo
Magnesium sulphate & Placebo
Pregabalin & Magnesium sulphate
Placebo
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Pregabalin & placebo

Magnesium sulphate & Placebo

Pregabalin & Magnesium sulphate

Placebo

Arm Description

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

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.

: 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.

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

Outcomes

Primary Outcome Measures

Total morphine consumption
patients are given regular intravenous morphine through patient controlled analgesia (PCA) and morphine consumption calculated from the PCA device

Secondary Outcome Measures

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

Full Information

First Posted
February 5, 2016
Last Updated
September 21, 2021
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT02678117
Brief Title
Analgesic Potentials of Preoperative Pregabalin,Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain
Official Title
Analgesic Potentials of Preoperative Oral Pregabalin,Intravenous Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain.(Randomized,Double-Blind Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin & placebo
Arm Type
Active Comparator
Arm Description
: will receive single dose oral Pregabalin 300 mg one hour preoperative and 200 ml of normal saline over 20 min.
Arm Title
Magnesium sulphate & Placebo
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pregabalin & Magnesium sulphate
Arm Type
Active Comparator
Arm Description
: 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
will receive placebo medications at the same time and route of administration of other groups.
Intervention Type
Drug
Intervention Name(s)
Pregabalin & Placebo
Intervention Type
Drug
Intervention Name(s)
Magnesium sulphate & Placebo
Intervention Type
Drug
Intervention Name(s)
Pregabalin & Magnesium sulphate
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Total morphine consumption
Description
patients are given regular intravenous morphine through patient controlled analgesia (PCA) and morphine consumption calculated from the PCA device
Time Frame
First 24 hours in postoperative period
Secondary Outcome Measure Information:
Title
Pain intensity using Visual Analogue Scale
Description
Assessment of pain intensity every 4 hours in the first 24 hours in postoperative period
Time Frame
First 24 hours in postoperative period
Title
Recovery Time
Description
Time taken for recovery of the patient to be fully awake
Time Frame
Immediately after ending the surgery
Title
Heart Rate
Description
Assessment of Heart Rate every 4 hours
Time Frame
First 24 hours in postoperative period
Title
Blood Pressure
Description
Assessment of Blood Pressure every 4 hours
Time Frame
First 24 hours in postoperative period
Title
Oxygen saturation
Description
Assessment of Oxygen saturation every 4 hours
Time Frame
First 24 hours in postoperative period
Title
Respiratory Rate
Description
Assessment of Respiratory Rate every 4 hours
Time Frame
First 24 hours in postoperative period
Title
Postoperative nausea and vomiting
Description
Postoperative nausea and vomiting scale (none 0, mild 1, moderate 2 , sever 3)
Time Frame
First 24 hours in postoperative period
Title
Side effects from the used drugs
Time Frame
First 24 hours in postoperative period
Title
Sedation score
Description
Using Ramsay Sedation score
Time Frame
First 24 hours in postoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA status of1 or 2 Patients undergoing thoracotomy 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naglaa A Ahmed, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be available within 6 months of study completion
Citations:
PubMed Identifier
23524696
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.
Results Reference
background
PubMed Identifier
21431050
Citation
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.
Results Reference
background
PubMed Identifier
30730476
Citation
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.
Results Reference
derived

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

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