|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
25 January 2016 |
|
Main ID: |
NCT02411890 |
|
Date of registration:
|
29/03/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Postoperative Pain Between ACB and FNB After ACLR
|
|
Scientific title:
|
The Comparison of Postoperative Analgesia Between Adductor Canal Block and Femoral Nerve Block After Arthroscopic ACL Reconstruction With Hamstring Graft: A Randomized Controlled Trial |
|
Date of first enrolment:
|
February 2015 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02411890 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Thailand
| | | | | | | |
|
Contacts
|
|
Name:
|
Alisa Seangleulur, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Thammasat University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- arthroscopic anterior cruciate ligament reconstruction with hamstring graft at
Thammasat University Hospital.
- age 15-80 years
- ASA class I-III
Exclusion Criteria:
- refuse to participate the study
- morbid obesity (BMI = 35 kg.m2)
- allergic to any medication in the study
- chronic opioid use or abuse
- lower extremity neurological dysfunction
- patients who cannot cooperate and assess pain score themselves.
Age minimum:
15 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Anterior Cruciate Ligament/Surgery
|
|
Knee Arthroscopy
|
|
Pain, Postoperative
|
|
Intervention(s)
|
|
Procedure: Adductor canal block (sham block)
|
|
Procedure: Femoral nerve block (active)
|
|
Procedure: Femoral nerve block (sham block)
|
|
Procedure: Adductor canal block (active)
|
|
Primary Outcome(s)
|
|
Pain score (VAS) during activity
[Time Frame: 24 hours postoperative]
|
|
Secondary Outcome(s)
|
|
Postoperative pruritus or rash
[Time Frame: 0-24 hours postoperative]
|
|
duration (hours) after surgery-first time that patients pressing PCA
[Time Frame: 0-24 hours postoperative]
|
|
Opioid consumption
[Time Frame: 0-24 hours postoperative]
|
|
Pain score (VAS) at activity
[Time Frame: 4, 8, 12, 16, 20 hours postoperative, and during quadriceps strength testing]
|
|
Postoperative nausea and vomiting
[Time Frame: 0-24 hours postoperative]
|
|
Postoperative urinary retention
[Time Frame: 0-24 hours postoperative]
|
|
Pain score (VAS) at rest
[Time Frame: 4, 8, 12, 16, 20, 24 hours postoperative]
|
|
Postoperative respiratory depression
[Time Frame: 0-24 hours postoperative]
|
|
The reduction of quadriceps strength from preoperative period both knees
[Time Frame: 8-12, 24 hours]
|
|
Secondary ID(s)
|
|
MTU-EC-AN-6-014/58
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|