Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia

October 16, 2019 updated by: Fatma Kavak Akelma, Ankara Diskapi Training and Research Hospital

Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction (ACL)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altindag
      • Ankara, Altindag, Turkey
        • Diskapi Teaching and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pregabalin (lyrica)
pregabalin (lyrica) 150 mg preoperative 1 hour before and the postoperative sham block will perform.
Drug: pregabalin (lyrica)
preoperative pregabalin and the postoperative sham block will perform.
Placebo Comparator: placebo group
a placebo capsule 1 hour before surgery and the postoperative sham block will perform.
Drug: Placebo oral tablet
The preoperative placebo oral tablet and the postoperative sham block will perform.
Active Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Diskapi Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

May 18, 2018

First Posted (Actual)

May 21, 2018

Study Record Updates

Last Update Posted (Actual)

October 18, 2019

Last Update Submitted That Met QC Criteria

October 16, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pregabalin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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