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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05083793
Enrollment
90
Registered
2021-10-19
Start date
2020-04-01
Completion date
2022-01-01
Last updated
2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

pregabalin

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.

Interventions

DRUGPregabalin 150mg

The effect of pregabalin on post-operative pain

OTHERPlacebo

patients will receive placebo one hour before operation

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)

Masking description

care provider

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Morphia dose24 hour postoperativethe total amount of rescue morphine received by patients for 24h postoperatively.

Secondary

MeasureTime frameDescription
Postoperative pain24 hour postoperativepost operative VAS score

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026