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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-21

Study Completion Date

2021-08-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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pregabalin group

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.

Group Type ACTIVE_COMPARATOR

Pregabalin 150mg

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Pregabalin 150mg

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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 .

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No