A Phase 2 interventional study of Pregabalin 150mg and Placebo in Postoperative Pain, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by Assiut University · Phase 2, Interventional, and Supportive care
The effect of pregabalin on post-operative pain and opioid consumption in spine surgery, a prospective, randomized, controlled study
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 90 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
patients have spine surgery receive oral pregabalin 150 mg 1 hour before surgery
Drug: Pregabalin 150mg
patients will receive placebo 1 hour before surgery with a sip of water.
Other: Placebo
The effect of pregabalin on post-operative pain
Also known as: Pregabalin
patients will receive placebo one hour before operation
Morphia dose
the total amount of rescue morphine received by patients for 24h postoperatively.
Time frame: 24 hour postoperative
Postoperative pain
post operative VAS score
Time frame: 24 hour postoperative
Plan to share: Yes — make individual participant data (IPD) available to other researchers
Supporting information: Study protocol
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Assiut University