Preemptive Pregabalin in Myringoplasty

Post-operative Analgesia Clinical Trial

Official title:

Effect of Preemptive Pregabalin for Post-operative Pain Relief in Myringoplasty

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03603626
• Other study ID #: 13/18
• Status: Withdrawn
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2018
• Source: Dhulikhel Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to investigate the effect of preemptive pregabalin on post-operative pain reduction after myringoplasty.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• CSOM - Chronic Suppurative Otitis Media
• Otitis Media
• Otitis Media, Suppurative
• Post-operative Analgesia

Intervention

Drug:
• Pregabalin 150mg
Preemptive pregabalin 150 mg administered 1 hour before surgery
• Placebo oral capsule
Placebo administered 1 hour before surgery

Locations

Country	Name	City	State
Nepal	Dhulikhel Hospital	Dhulikhel	Kavre

Sponsors (2)

Lead Sponsor	Collaborator
Dhulikhel Hospital	Kathmandu University School of Medical Sciences

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 6, 12, 24, 48 hours in postoperative period