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

NCT05071118 | Completed Phase 4

• 1 other identifier: FMASU R71/2021
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• recovery time

  three months

• motor block duration

  three months

• postoperative analgesia

  three months.

Study Arms (2)

pregabalin group

ACTIVE COMPARATOR

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

placebo group

ACTIVE COMPARATOR

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

Drug: Placebo

Interventions

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

pregabalin group

Placebo DRUG

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

placebo group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 8, 2021
• Study Start: March 21, 2021
• Primary Completion: August 15, 2021
• Study Completion: August 25, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-09

Locations

EG (1)