Postoperative Pain
Conditions
Keywords
Total knee replacement, Postoperative pain, Pregabalin, Adductor canal block, Dexmedetomidine
Brief 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.
Detailed 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.
Interventions
DRUGPregabalin 75mg
Group pregabalin will receive cap pregabalin 75mg as premedication and will continue as B.D dose for 72 Hrs.
PROCEDUREadductor canal block
Both group will receive ultrasound guided Adductor canal block with bupivacaine 0.2% 20-30ml and dexmedetomidine 1mcg/Kg
Sponsors
Bahrain Defence Force Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale Score (0-10) | 72 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Sedation score at 1st Continuous Passive Movement | with in 24 hours | visual analogue score at 1st continuous passive movement |
| Time of 1st analgesia request | within 24 hours | Estimation of time for 1st complaint of pain |
| Incident of bradycardia | within 24hours | Incident of reduction in Heart rate in 1st 24 Hours |
| Richmond Agitation Sedation Scale score {(+4) -0- (-5)} | 72 hours | 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. |
| Total opioid consumption | within 72 hours | Total opioid consumption in 72hours: Oxycodone/Morphine |
| Patient satisfaction | within 72 hours | Patient satisfaction at 72 hours: rated as numeric 1-5 (1=not satisfied, 5=fully satisfied) |
| Incident of Hypotension | within 24 hours | Incident of reduced blood pressure below baseline |
Countries
Bahrain
Contacts
Primary ContactMEHTASH BUTT, FCPS,FCAI
Backup ContactJalal alkhan, MBBch,FRCA
Outcome results
None listed