the Effect of Pregabalin on Postoperative Pain and Opioid Consumption in Spine Surgery

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: January 1, 2022

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.

Interventions

  • Drug: Pregabalin 150mg
    • The effect of pregabalin on post-operative pain
  • Other: Placebo
    • patients will receive placebo one hour before operation

Arms, Groups and Cohorts

  • Experimental: Study group
    • patients have spine surgery receive oral pregabalin 150 mg 1 hour before surgery
  • Placebo Comparator: Placebo group
    • patients will receive placebo 1 hour before surgery with a sip of water.

Clinical Trial Outcome Measures

Primary Measures

  • Morphia dose
    • Time Frame: 24 hour postoperative
    • the total amount of rescue morphine received by patients for 24h postoperatively.

Secondary Measures

  • Postoperative pain
    • Time Frame: 24 hour postoperative
    • post operative VAS score

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohamed galal aly, Professor of anesthesia and intensive care – Assiut University
  • Overall Official(s)
    • Mahmoud Maher, MD, Study Chair, Assiut University Hospitals

References

Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia. 2004;45 Suppl 6:13-8. doi: 10.1111/j.0013-9580.2004.455003.x.

Hindmarch I, Trick L, Ridout F. A double-blind, placebo- and positive-internal-controlled (alprazolam) investigation of the cognitive and psychomotor profile of pregabalin in healthy volunteers. Psychopharmacology (Berl). 2005 Dec;183(2):133-43. doi: 10.1007/s00213-005-0172-7. Epub 2005 Nov 9.

Sebastian B, Talikoti AT, Nelamangala K, Krishnamurthy D. Effect of Oral Pregabalin as Preemptive Analgesic in Patients Undergoing Lower Limb Orthopedic Surgeries under Spinal Anaesthesia. J Clin Diagn Res. 2016 Jul;10(7):UC01-4. doi: 10.7860/JCDR/2016/18854.8081. Epub 2016 Jul 1.

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