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Completed

NCT Number: NCT05071118

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

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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Key information

Conditions

Anesthesia

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Pregabalin 150mg

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

Drug

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

Primary outcomes

  1. onset of spinal anaesthesia

    Time frame: 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 outcomes

  1. recovery time

    Time frame: three months

    Recovery time from the sensory blockade (2-dermatome regression of anesthesia from the maximum level).

  2. motor block duration

    Time frame: three months

    the time for return to Bromag 2 (the patient is able to move knees and ankles).

  3. postoperative analgesia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

the Effect of Adding Pregabalin on the Onset and the Duration of Spinal Anesthesia and on the Postoperative Analgesia

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2021
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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