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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071118
• Other study ID #: FMASU R71/2021
• Status: Completed
• Phase: Phase 4
• Start date: March 21, 2021
• Est. completion date: August 25, 2021

Study information

• Verified date: September 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 25, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Anesthesia

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	recovery time	Recovery time from the sensory blockade (2-dermatome regression of anesthesia from the maximum level).	three months
Secondary	motor block duration	the time for return to Bromag 2 (the patient is able to move knees and ankles).	three months
Secondary	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.