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| ID | Type | Description | Link |
|---|---|---|---|
| BDF/R&REC/2023/674 | Other Identifier | crown prince training and research centre, Bahrain |
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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.
After obtaining approval from the institutional ethical committee and informed written consent, 120 patients fulfilling the inclusion criteria will be included in this study. The patients will be randomly assigned into two equal groups; Group P: Pregabalin group and Group C: control group. Group P will receive oral capsule pregabalin 75mg one hour preoperatively and Group C will not receive any premedication preoperatively.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin group | Active Comparator | this group of patient will receive cap pregabalin 75mg as premedication and will continue as twice daily dose for 72 hrs. |
|
| Control group | Sham Comparator | This group of patient will not receive cap pregabalin but it will receive standard medical care as routine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 75mg | Drug | Group pregabalin will receive cap pregabalin 75mg as premedication and will continue as B.D dose for 72 Hrs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Visual Analogue Sedation score at 1st Continuous Passive Movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MEHTASH BUTT, FCPS,FCAI | Contact | +97336681277 | dr.mehtashbutt@yahoo.com | |
| Jalal alkhan, MBBch,FRCA | Contact | +97317766666 | 6268 | drjalkhan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohammed Al Muharraqi, FRCS,FDSRCS | Bahrain Defence Forces Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bahrain Defence Force | Recruiting | Manama | 323 | Bahrain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31663286 | Result | 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. | |
| 29049117 | Result | 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. |
| Label | URL |
|---|---|
| Pregabalin | View source |
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We're still formulating the extended contact plan to follow patients for chronic pain.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2023 | Dec 17, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 19, 2023 | Dec 5, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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The patients will be randomly assigned into two equal groups; Group P: Pregablain group and Group C: control group. Group P will receive oral capsule pregabalin 75mg one hour preoperatively and will continue as B.D for 72 hrs, Group C will not receive any premedication preoperatively.
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.
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| adductor canal block | Procedure | Both group will receive ultrasound guided Adductor canal block with bupivacaine 0.2% 20-30ml and dexmedetomidine 1mcg/Kg |
|
|
visual analogue score at 1st continuous passive movement |
| with in 24 hours |
| Time of 1st analgesia request | Estimation of time for 1st complaint of pain | within 24 hours |
| Incident of bradycardia | Incident of reduction in Heart rate in 1st 24 Hours | within 24hours |
| Incident of Hypotension | Incident of reduced blood pressure below baseline | within 24 hours |
| Total opioid consumption | Total opioid consumption in 72hours: Oxycodone/Morphine | within 72 hours |
| Patient satisfaction | Patient satisfaction at 72 hours: rated as numeric 1-5 (1=not satisfied, 5=fully satisfied) | within 72 hours |
| 20402746 | Result | 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. |
| 25830118 | Result | 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. |
| 33426669 | Result | 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. |
| 30475260 | Result | 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. |
| 30679332 | Result | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |