Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia

NCT ID: NCT03530280

Last Updated: 2019-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Pain After Knee Arthroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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pregabalin (lyrica)

pregabalin (lyrica) 150 mg preoperative 1 hour before and the postoperative sham block will perform.

Group Type ACTIVE_COMPARATOR

pregabalin (lyrica)

Intervention Type DRUG

preoperative pregabalin and the postoperative sham block will perform.

placebo group

a placebo capsule 1 hour before surgery and the postoperative sham block will perform.

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

The preoperative placebo oral tablet and the postoperative sham block will perform.

adductor channel block group

A preoperative placebo capsule will be given.This group will receive postoperative adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine

Group Type ACTIVE_COMPARATOR

adductor canal block including bupivacaine

Intervention Type DRUG

The preoperative placebo oral tablet and adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine

Interventions

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pregabalin (lyrica)

preoperative pregabalin and the postoperative sham block will perform.

Intervention Type DRUG

Placebo oral tablet

The preoperative placebo oral tablet and the postoperative sham block will perform.

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara Diskapi Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fatma Kavak Akelma

specialist doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diskapi Teaching and Research Hospital

Ankara, Altindag, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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pregabalin

Identifier Type: -

Identifier Source: org_study_id

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