Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia
1 other identifier
interventional
51
1 country
1
Brief Summary
arthroscopically Anterior Cruciate Ligament Reconstruction (ACL) under spinal anesthesia were included in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2018
CompletedFirst Posted
Study publicly available on registry
May 21, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 18, 2019
October 1, 2019
4 months
March 26, 2018
October 16, 2019
Conditions
Keywords
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 COMPARATORpregabalin (lyrica) 150 mg preoperative 1 hour before and the postoperative sham block will perform.
placebo group
PLACEBO COMPARATORa placebo capsule 1 hour before surgery and the postoperative sham block will perform.
adductor channel block group
ACTIVE COMPARATORA 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
Interventions
preoperative pregabalin and the postoperative sham block will perform.
The preoperative placebo oral tablet and the postoperative sham block will perform.
The preoperative placebo oral tablet and adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine
Eligibility Criteria
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)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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