Preemptive Pregabalin in Myringoplasty
Primary Purpose
Post-operative Analgesia, CSOM - Chronic Suppurative Otitis Media
Status
Withdrawn
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Pregabalin 150mg
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Analgesia focused on measuring Endoscopic ear surgery, Myringoplasty, Pregabalin, Preemptive analgesia
Eligibility Criteria
Inclusion Criteria:
- Cases of Chronic suppurative otitis media (CSOM) inactive planned for endoscopic myringoplasty under local anesthesia,
- Age >= 18 years
- either sex.
Exclusion Criteria:
- Revision cases,
- Pregnancy or breastfeeding,
- Known or suspected sensitivity or contraindication to pregabalin,
- Patient using medication for chronic pain,
- History of seizure disorder,
- Mental retardation.
Sites / Locations
- Dhulikhel Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Preemptive pregabalin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
This study is constructed to determine whether the use of preemptive single dose oral pregabalin would decrease post-operative pain in patient undergoing myringoplasty.
Post-operative pain severity was assessed with Visual Analogue Scale (VAS). It's a 10cm scale in which 0 represents no pain at all and 10 represents the worst pain imaginable. VAS score was compared between 2 groups at 6, 12, 24, 48 hrs post-operative period. This would show if there is any change in pain score between groups using pregabalin or placebo in the given time frame.
Secondary Outcome Measures
Full Information
NCT ID
NCT03603626
First Posted
July 7, 2018
Last Updated
September 21, 2018
Sponsor
Dhulikhel Hospital
Collaborators
Kathmandu University School of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03603626
Brief Title
Preemptive Pregabalin in Myringoplasty
Official Title
Effect of Preemptive Pregabalin for Post-operative Pain Relief in Myringoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
the article is not a clinical trial but is a hospital based randomized comparative study. This was inadvertently uploaded.
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dhulikhel Hospital
Collaborators
Kathmandu University School of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study was to investigate the effect of preemptive pregabalin on post-operative pain reduction after myringoplasty.
Detailed Description
Patient were randomly assigned to one of two groups with 30 participants each by lottery method. Pregabalin group received capsule Pregabalin 150mg and Placebo group were given Vitamin B capsule 1 hour prior to surgery.
All patients underwent endoscopic myringoplasty with tragal cartilage and perichondrium graft. Surgical procedure was done under local anesthesia. 5ml of 2% xylocaine with 1:2,00,000 adrenalin was infiltrated in the four quadrants of external ear canal and on tragus. Around 2cm incision was given on canal surface of tragus and around 2cm x 1.5cm cartilage- perichondrium graft was obtained. The skin was closed with 4/0 prolene interrupted suture. Using rigid Hopkins II 0-degree endoscope (Karl Storz) with 4-millimeter diameter and 18 centimeters in length, margin of perforation was refreshed. Gelatin sponge was kept in the middle ear and cartilage perichondrium graft placed. Canal was then packed with gelatin soaked in ciprofloxacin ear drops followed by ribbon pack medicated with soframycin. Small dressing was applied over it.
Post-operative pain severity was assessed with VAS scale at 6, 12, 24, 48 hours. Rescue analgesia is given with Injection Ketorolac (30mg IV) or Tab Flexon (Ibuprofen 400mg + Paracetamol 500mg) whenever the patient required.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Analgesia, CSOM - Chronic Suppurative Otitis Media
Keywords
Endoscopic ear surgery, Myringoplasty, Pregabalin, Preemptive analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preemptive pregabalin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150mg
Intervention Description
Preemptive pregabalin 150 mg administered 1 hour before surgery
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Vitamin B capsule
Intervention Description
Placebo administered 1 hour before surgery
Primary Outcome Measure Information:
Title
This study is constructed to determine whether the use of preemptive single dose oral pregabalin would decrease post-operative pain in patient undergoing myringoplasty.
Description
Post-operative pain severity was assessed with Visual Analogue Scale (VAS). It's a 10cm scale in which 0 represents no pain at all and 10 represents the worst pain imaginable. VAS score was compared between 2 groups at 6, 12, 24, 48 hrs post-operative period. This would show if there is any change in pain score between groups using pregabalin or placebo in the given time frame.
Time Frame
At 6, 12, 24, 48 hours in postoperative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cases of Chronic suppurative otitis media (CSOM) inactive planned for endoscopic myringoplasty under local anesthesia,
Age >= 18 years
either sex.
Exclusion Criteria:
Revision cases,
Pregnancy or breastfeeding,
Known or suspected sensitivity or contraindication to pregabalin,
Patient using medication for chronic pain,
History of seizure disorder,
Mental retardation.
Facility Information:
Facility Name
Dhulikhel Hospital
City
Dhulikhel
State/Province
Kavre
ZIP/Postal Code
45210
Country
Nepal
12. IPD Sharing Statement
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Preemptive Pregabalin in Myringoplasty
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