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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Pregabalin 150mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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
Active Comparator: placebo group; The patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery .	Drug: Placebo; The patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
onset of spinal anaesthesia	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	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recovery time	Recovery time from the sensory blockade (2-dermatome regression of anesthesia from the maximum level).	three months
motor block duration	the time for return to Bromag 2 (the patient is able to move knees and ankles).	three months
postoperative analgesia	• 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.	three months.

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2021
• Primary Completion (Actual): August 15, 2021
• Study Completion (Actual): August 25, 2021

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: FMASU R71/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No