Effect of Perioperative Oral Pregabalin in Total Knee Replacement
NCT ID: NCT06187922
Last Updated: 2024-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2023-09-01
2025-07-30
Brief Summary
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Detailed Description
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Intraoperatively both groups will receive inj. Midazolam 2 mg before subarachnoid block with hyperbaric Bupivacaine 0.5% 2.5-3ml and fentanyl 15mcg in the operation theatre (OT). Both groups will also receive parecoxib 40mg IV and paracetamol 1G Intravenous (IV) as part of multimodal analgesia. Both groups will receive dexamethasone 8mg IV prophylactically.
Postoperatively both groups will receive Ultrasound guided Adductor canal saphenous Nerve block in the PACU with 0.2% Bupivacaine 20-30ml \& dexmeditomidine1.0mcg/kg. Group P will receive oral capsule pregabalin 75 mg Q12hourly from the 1st dose for next 60 hours. Group C will not receive any medication. Both groups will receive paracetamol 1G IV Q6Hourly and Rescue Analgesia will be provided with oral oxycodone 5mg TDS and Morphine PCA, in escalating manner as per patient requirement.
for 24 hrs. After 24 hours Both groups with receive tab paracetamol1 g Q4hourly, ibuprofen 400 Q8hourly along with Tab oxycodone as PRN Q8Hourly and PCA morphine.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Intraoperatively both groups will receive inj. Midazolam 2 mg before subarachnoid block with hyperbaric Bupivacaine 0.5% 2.5-3ml and fentanyl 15mcg in the operation theatre (OT). Both groups will also receive parecoxib 40mg IV and paracetamol 1G Intravenous (IV) as part of multimodal analgesia. Both groups will receive dexamethasone 8mg IV prophylactically. Postoperatively both groups will receive adductor canal block with bupivacaine and dexmedetomidine.
TREATMENT
NONE
Study Groups
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Pregabalin group
this group of patient will receive cap pregabalin 75mg as premedication and will continue as twice daily dose for 72 hrs.
Pregabalin 75mg
Group pregabalin will receive cap pregabalin 75mg as premedication and will continue as B.D dose for 72 Hrs.
adductor canal block
Both group will receive ultrasound guided Adductor canal block with bupivacaine 0.2% 20-30ml and dexmedetomidine 1mcg/Kg
Control group
This group of patient will not receive cap pregabalin but it will receive standard medical care as routine
adductor canal block
Both group will receive ultrasound guided Adductor canal block with bupivacaine 0.2% 20-30ml and dexmedetomidine 1mcg/Kg
Interventions
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Pregabalin 75mg
Group pregabalin will receive cap pregabalin 75mg as premedication and will continue as B.D dose for 72 Hrs.
adductor canal block
Both group will receive ultrasound guided Adductor canal block with bupivacaine 0.2% 20-30ml and dexmedetomidine 1mcg/Kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Elective Regional anesthesia.
3. Able to follow study protocol
Exclusion Criteria
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
18 Years
85 Years
ALL
No
Sponsors
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Bahrain Defence Force Hospital
OTHER
Responsible Party
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Mehtash butt
Chief resident
Principal Investigators
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Mohammed Al Muharraqi, FRCS,FDSRCS
Role: STUDY_CHAIR
Bahrain Defence Forces Hospital
Locations
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Bahrain Defence Force
Manama, , Bahrain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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):e24837. doi: 10.5812/aapm.24837. eCollection 2015 Feb.
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.
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.
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;44(3):333-340. doi: 10.1136/rapm-2018-100089. Epub 2019 Jan 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
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Other Identifiers
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BDF/R&REC/2023/674
Identifier Type: OTHER
Identifier Source: secondary_id
BDF/R&REC/2023/674
Identifier Type: -
Identifier Source: org_study_id
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