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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03530280
Other study ID # pregabalin
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date December 1, 2018

Study information

Verified date October 2019
Source Ankara Diskapi Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

arthroscopically Anterior Cruciate Ligament Reconstruction (ACL) under spinal anesthesia were included in this study.


Description:

Patients who American Society of Anesthesiologists (ASA) classification I to II scheduled to undergo arthroscopically assisted ACL reconstructions under spinal anesthesia are included in this study. The first group is administered 150 mg oral pregabalin 1 hour before surgery and the postoperative sham block was performed with an ultrasound probe. The second group is the control group; patients in this group are administered a placebo capsule 1 hour before surgery and sham block was performed with an ultrasound probe.The third group is administered a placebo capsule 1 hour before surgery and postoperative adductor canal block is performed. All patients will be received postoperative a tramadol i.v. patient control analgesia device. At the end of 24 hours, the total amount of tramadol consumed by the patient will be recorded from the patient control analgesia. NRS score, white fast track, satisfaction will be questioned.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date December 1, 2018
Est. primary completion date October 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients between the ages of 18 and 70 years

- American Society of Anesthesiologists I or II

- Scheduled to undergo knee arthroscopy

Exclusion Criteria:

- allergic to any medicines

- History of drug or alcohol abuse,

- Opioids or sedative medications

- History of psychiatric conditions

- Pregnant or lactating women

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
pregabalin (lyrica)
preoperative pregabalin and the postoperative sham block will perform.
Placebo oral tablet
The preoperative placebo oral tablet and the postoperative sham block will perform.
adductor canal block including bupivacaine
The preoperative placebo oral tablet and adductor channel block including 10 mL of 0.25% bupivacaine with 5 µg/mL epinephrine

Locations

Country Name City State
Turkey Diskapi Teaching and Research Hospital Ankara Altindag

Sponsors (1)

Lead Sponsor Collaborator
Ankara Diskapi Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 11-point numerical rating scale (NRS) 11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained. 24 hours
Primary tramadol consumption 24 hours tramadol consumption will be recorded as milligrams 24 hours