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

Assiut University

Status and phase

Unknown

Phase 2

Conditions

Postoperative Pain

Treatments

Other: Placebo

Drug: Pregabalin 150mg

Study type

Interventional

Funder types

Other

Identifiers

NCT05083793

17101526

Details and patient eligibility

About

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

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.