Effect of Perioperative Oral Pregabalin in Total Knee Replacement

Postoperative Pain Clinical Trial

— TKR  

Official title:

Effect of Perioperative Oral Pregabalin in Total Knee Replacement for Postoperative Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06187922
• Other study ID #: BDF/R&REC/2023/674
• Secondary ID: BDF/R&REC/2023/6
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: December 2023
• Source: Bahrain Defence Force Hospital
• Contact: MEHTASH BUTT, FCPS,FCAI
• Phone: +97336681277
• Email: dr.mehtashbutt[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Pregabalin 75mg
Group pregabalin will receive cap pregabalin 75mg as premedication and will continue as B.D dose for 72 Hrs.

Procedure:
• adductor canal block
Both group will receive ultrasound guided Adductor canal block with bupivacaine 0.2% 20-30ml and dexmedetomidine 1mcg/Kg

Locations

Country	Name	City	State
Bahrain	Bahrain Defence Force	Manama

Sponsors (1)

Lead Sponsor	Collaborator
Bahrain Defence Force Hospital

Country where clinical trial is conducted

Bahrain, 

References & Publications (7)

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

Outcome

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

External Links

•   Pregabalin