The Efficacy of Pregabalin on the Duration of the Spinal Anesthesia and the Early Postoperative Pain After Total Knee Arthroplasty

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Pregabalin 150mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05071118

FMASU R71/2021

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

pregabalin group

Active Comparator group

Description:

Two hours before surgery, the pregabalin patients (group P) received capsules containing 150mg of pregabalin in the ward then transferred to OR to receive spinal anesthesia before surgery.

Treatment:

Drug: Pregabalin 150mg

placebo group

Active Comparator group

Description:

The patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery .

Treatment:

Drug: Placebo