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

Phase 2

• Conditions: Postoperative Pain
• Interventions: Drug: Pregabalin 150mg; Other: Placebo

• Registration Number: NCT05083793
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2020-04-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-06
• Last Update Submitted: 2021-10-06
• Study First Posted: 2021-10-19
• Last Update Posted: 2021-10-19
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Pregabalin 150mg	patients have spine surgery receive oral pregabalin 150 mg 1 hour before surgery
Placebo group	Placebo	patients will receive placebo 1 hour before surgery with a sip of water.

Primary Outcome Measures

Name	Time	Method
Morphia dose	24 hour postoperative	the total amount of rescue morphine received by patients for 24h postoperatively.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	24 hour postoperative	post operative VAS score

Trial Locations

Locations (1)

Mahmoud Maher; 🇪🇬 Assiut, Egypt