Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia
Primary Purpose
Postoperative Pain After Knee Arthroscopy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
pregabalin (lyrica)
Placebo oral tablet
adductor canal block including bupivacaine
Sponsored by
About this trial
This is an interventional other trial for Postoperative Pain After Knee Arthroscopy focused on measuring pregabalin, adductor canal block, postoperative pain
Eligibility Criteria
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
Sites / Locations
- Diskapi Teaching and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
pregabalin (lyrica)
placebo group
adductor channel block group
Arm Description
pregabalin (lyrica) 150 mg preoperative 1 hour before and the postoperative sham block will perform.
a placebo capsule 1 hour before surgery and the postoperative sham block will perform.
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
Outcomes
Primary Outcome Measures
11-point numerical rating scale (NRS)
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
tramadol consumption
24 hours tramadol consumption will be recorded as milligrams
Secondary Outcome Measures
Full Information
NCT ID
NCT03530280
First Posted
March 26, 2018
Last Updated
October 16, 2019
Sponsor
Ankara Diskapi Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03530280
Brief Title
Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia
Official Title
Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction (ACL)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Diskapi Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
arthroscopically Anterior Cruciate Ligament Reconstruction (ACL) under spinal anesthesia were included in this study.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain After Knee Arthroscopy
Keywords
pregabalin, adductor canal block, postoperative pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pregabalin (lyrica)
Arm Type
Active Comparator
Arm Description
pregabalin (lyrica) 150 mg preoperative 1 hour before and the postoperative sham block will perform.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
a placebo capsule 1 hour before surgery and the postoperative sham block will perform.
Arm Title
adductor channel block group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
pregabalin (lyrica)
Intervention Description
preoperative pregabalin and the postoperative sham block will perform.
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
The preoperative placebo oral tablet and the postoperative sham block will perform.
Intervention Type
Drug
Intervention Name(s)
adductor canal block including bupivacaine
Intervention Description
The preoperative placebo oral tablet and adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine
Primary Outcome Measure Information:
Title
11-point numerical rating scale (NRS)
Description
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
Time Frame
24 hours
Title
tramadol consumption
Description
24 hours tramadol consumption will be recorded as milligrams
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Diskapi Teaching and Research Hospital
City
Ankara
State/Province
Altindag
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia
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