Anesthesia
Conditions
Brief summary
the purpose of this study is to evaluate the effectiveness of administration of pregabalin 2 hours preoperatively on the onset and the duration of the spinal anesthesia in total knee arthroplasty and the role of pregabalin in postoperative analgesia.
Interventions
DRUGPregabalin 150mg
pregabalin patients (group P) received capsules containing 150mg of pregabalin in the ward then transferred to OR to receive spinal anesthesia before surgery
DRUGPlacebo
The patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery .
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* the ages of 40 and 70 years * height 155-170 cm * American Society of Anesthesiologists grade I or II . * patients underwent total knee arthroplasty under spinal anesthesia
Exclusion criteria
* patients known to be allergic to any medicines. * patients had a history of drug or alcohol abuse. * patients were taking opioids or sedative medications, * patients Inability to communicate with investigators to evaluate the postoperative pain * patients were in need for postoperative ICU hospitalization . * patients had a history of psychiatric conditions. * Patients with a history of taking pregabalin or gabapentin .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| onset of spinal anaesthesia | three months | seventy participants undergoing elective total knee arthroplasty under spinal anesthesia half of them took placebo and the other half took 150 mg pregabalin two hours before the procedure and calculate the time from the base line to the onset of anesthesia. Our primary outcome is to assess the onset of spinal anesthesia. to detect the onset of spinal anaesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recovery time | three months | Recovery time from the sensory blockade (2-dermatome regression of anesthesia from the maximum level). |
| motor block duration | three months | the time for return to Bromag 2 (the patient is able to move knees and ankles). |
| postoperative analgesia | three months. | • Postoperative pain will be assessed by the patient using the visual analog scale in the first 24 hour(VAS, 0=no pain; 10=worst possible pain) every 2 hours up to 24 hours after the operation. |
Countries
Egypt
Outcome results
None listed