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

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Pregabalin 150mg; Drug: Placebo

• Registration Number: NCT05071118
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-21
• Primary Completion: 2021-08-15
• Study Completion: 2021-08-25
• Status Verified: 2021-09
• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-27
• Last Update Submitted: 2021-09-27
• Study First Posted: 2021-10-08
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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 .

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pregabalin group	Pregabalin 150mg	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.
placebo group	Placebo	The patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery .

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt