NCT03530280

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 18, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

March 26, 2018

Last Update Submit

October 16, 2019

Conditions

Keywords

pregabalinadductor canal blockpostoperative pain

Outcome Measures

Primary Outcomes (2)

  • 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

  • tramadol consumption

    24 hours tramadol consumption will be recorded as milligrams

    24 hours

Study Arms (3)

pregabalin (lyrica)

ACTIVE COMPARATOR

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

Drug: pregabalin (lyrica)

placebo group

PLACEBO COMPARATOR

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

Drug: Placebo oral tablet

adductor channel block group

ACTIVE COMPARATOR

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

Interventions

preoperative pregabalin and the postoperative sham block will perform.

pregabalin (lyrica)

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

placebo group

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

adductor channel block group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages of 18 and 70 years
  • American Society of Anesthesiologists I or II
  • Scheduled to undergo knee arthroscopy

You may not qualify if:

  • allergic to any medicines
  • History of drug or alcohol abuse,
  • Opioids or sedative medications
  • History of psychiatric conditions
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Teaching and Research Hospital

Ankara, Altindag, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist doctor

Study Record Dates

First Submitted

March 26, 2018

First Posted

May 21, 2018

Study Start

June 1, 2018

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

October 18, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations