Postoperative Pain Clinical Trial
— TKROfficial title:
Effect of Perioperative Oral Pregabalin in Total Knee Replacement for Postoperative Pain
This interventional randomized control trial aim to determine efficacy and safety of Oral pregabalin in improving after surgery pain control in patients undergoing total knee replacement surgeries under regional anesthesia. We'll compare the efficacy of pregabalin between two groups, pregabalin group and control group on the basis of their opioid consumption after knee operation.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | July 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Age between 18 to 85 year 2. Elective Regional anesthesia. 3. Able to follow study protocol Exclusion Criteria: 1. ASA -IV 2. Age <18 & > 85 years 3. Patients on pregabalin for chronic neuropathic pain. 4. Patient under General anesthesia 5. Patients with chronic liver failure 6. Patients with chronic renal failure on Hemodialysis 7. Patients on opioid (>3 month) 8. Patient with complicated knee surgery |
Country | Name | City | State |
---|---|---|---|
Bahrain | Bahrain Defence Force | Manama |
Lead Sponsor | Collaborator |
---|---|
Bahrain Defence Force Hospital |
Bahrain,
Andersen JH, Jaeger P, Grevstad U, Estrup S, Geisler A, Vilhelmsen F, Dahl JB, Laier GH, Ilfeld BM, Mathiesen O. Systemic dexmedetomidine is not as efficient as perineural dexmedetomidine in prolonging an ulnar nerve block. Reg Anesth Pain Med. 2019 Mar;4 — View Citation
Attal N, Cruccu G, Baron R, Haanpaa M, Hansson P, Jensen TS, Nurmikko T. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol. 2010 Sep;17(9):1113-e88. doi: 10.1111/j.1468-1331.2010.02999.x. Epub 2010 Apr 9. — View Citation
Chen YK, Boden KA, Schreiber KL. The role of regional anaesthesia and multimodal analgesia in the prevention of chronic postoperative pain: a narrative review. Anaesthesia. 2021 Jan;76 Suppl 1(Suppl 1):8-17. doi: 10.1111/anae.15256. — View Citation
Hah JM, Bateman BT, Ratliff J, Curtin C, Sun E. Chronic Opioid Use After Surgery: Implications for Perioperative Management in the Face of the Opioid Epidemic. Anesth Analg. 2017 Nov;125(5):1733-1740. doi: 10.1213/ANE.0000000000002458. — View Citation
Li JW, Ma YS, Xiao LK. Postoperative Pain Management in Total Knee Arthroplasty. Orthop Surg. 2019 Oct;11(5):755-761. doi: 10.1111/os.12535. — View Citation
Sun Q, Liu S, Wu H, Ma H, Liu W, Fang M, Liu K, Pan Z. Dexmedetomidine as an Adjuvant to Local Anesthetics in Transversus Abdominis Plane Block: A Systematic Review and Meta-analysis. Clin J Pain. 2019 Apr;35(4):375-384. doi: 10.1097/AJP.0000000000000671. — View Citation
Ziyaeifard M, Mehrabanian MJ, Faritus SZ, Khazaei Koohpar M, Ferasatkish R, Hosseinnejad H, Mehrabanian M. Premedication with oral pregabalin for the prevention of acute postsurgical pain in coronary artery bypass surgery. Anesth Pain Med. 2015 Jan 17;5(1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analogue Scale Score (0-10) | visual analogue scale score at 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours. minimum score mean good outcome | 72 hours | |
Secondary | Richmond Agitation Sedation Scale score {(+4) -0- (-5)} | Richmond Agitation Sedation Scale score at 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours. score +/-1 to 0 means good outcome. | 72 hours | |
Secondary | Visual Analogue Sedation score at 1st Continuous Passive Movement | visual analogue score at 1st continuous passive movement | with in 24 hours | |
Secondary | Time of 1st analgesia request | Estimation of time for 1st complaint of pain | within 24 hours | |
Secondary | Incident of bradycardia | Incident of reduction in Heart rate in 1st 24 Hours | within 24hours | |
Secondary | Incident of Hypotension | Incident of reduced blood pressure below baseline | within 24 hours | |
Secondary | Total opioid consumption | Total opioid consumption in 72hours: Oxycodone/Morphine | within 72 hours | |
Secondary | Patient satisfaction | Patient satisfaction at 72 hours: rated as numeric 1-5 (1=not satisfied, 5=fully satisfied) | within 72 hours |
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