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Clinical Trials/NCT05083793
NCT05083793
Unknown
Phase 2

The Effect of Pregabalin on Post-operative Pain and Opioid Consumption in Spine Surgery, a Prospective, Randomized, Controlled Study

Assiut University1 site in 1 country90 target enrollmentApril 1, 2020

Overview

Phase
Phase 2
Intervention
Pregabalin 150mg
Conditions
Postoperative Pain
Sponsor
Assiut University
Enrollment
90
Locations
1
Primary Endpoint
Morphia dose
Last Updated
4 years ago

Overview

Brief Summary

The effect of pregabalin on post-operative pain and opioid consumption in spine surgery, a prospective, randomized, controlled study

Detailed Description

Aim of the work: The aim of our study is to compare the analgesic effect of pre-emptive oral pregabalin 150mg on acute postoperative pain and opioid consumption in spine surgery. Evaluated by visual analog scale (VAS) primary outcome measure is the total amount of rescue morphine received by patients for 24h postoperatively. secondary outcome measures include level of acute postoperative pain by VAS, and duration of hospital stay Patients and methods : This study will be carried out after being approved from the Medical Research Ethical Committee, Faculty of Medicine, Assiut University, Assiut, Egypt, and after obtaining a written informed consents from all participating patients. inclusion criteria: This prospective randomized clinical study will include eighty patients with ASA I-II, aged 18-60 years scheduled for spine surgery Exclusion criteria : Excluded from the study are patients with known allergy to the study drugs, significant cardiac, respiratory, renal, CNS or hepatic disease, drug or alcohol abuse, pregnant women, patients refusing participation and psychiatric or mental illness that would interfere with perception and assessment of pain.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
January 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed galal aly

Professor of anesthesia and intensive care

Assiut University

Eligibility Criteria

Inclusion Criteria

  • : This prospective randomized clinical study will include eighty patients with ASA I-II, aged 18-60 years scheduled for spine surgery

Exclusion Criteria

  • : Excluded from the study are patients with known allergy to the study drugs, significant cardiac, respiratory, renal, CNS or hepatic disease, drug or alcohol abuse, pregnant women, patients refusing participation and psychiatric or mental illness that would interfere with perception and assessment of pain.

Arms & Interventions

Study group

patients have spine surgery receive oral pregabalin 150 mg 1 hour before surgery

Intervention: Pregabalin 150mg

Placebo group

patients will receive placebo 1 hour before surgery with a sip of water.

Intervention: Placebo

Outcomes

Primary Outcomes

Morphia dose

Time Frame: 24 hour postoperative

the total amount of rescue morphine received by patients for 24h postoperatively.

Secondary Outcomes

  • Postoperative pain(24 hour postoperative)

Study Sites (1)

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