Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain

Postoperative Pain Clinical Trial

Official title:

Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01450345
• Other study ID #: toh2c79@Pregabalin
• Status: Recruiting
• Phase: Phase 3
• First received: September 24, 2011
• Last updated: October 11, 2011
• Start date: September 2009
• Est. completion date: December 2011

Study information

• Verified date: October 2011
• Source: University of Malaya
• Contact: CharngChee Toh, MBBS, MRCS
• Phone: 60193380337
• Email: toh2c79[@]yahoo.com
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study carry out is to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy, opiod sparing, adverse effect and clinical value in post-operative pain management.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of inguinal hernia

• Patient undergo operation under daycare basis

• ASA I-II

• Written consent

Exclusion Criteria:

• ASA > II

• Allergic reaction against gabapentin and/or pregabalin

• History of recurrent hernia repair.

• Patient who has taken analgesia prior to the surgery

• Liver failure

• Renal failure

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Pregabalin
The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.

Locations

Country	Name	City	State
Malaysia	University Malaya	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study is constructed to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy for post operative pain at Alert, 15, 30, 45, 60 and 120 min, Day 1, Day 2 and Day 3.	Efficacy: To compare the VAS score for pain after operation between the group at Alert, 15, 30, 45, 60 and 120 min, Day 1, Day 2 and Day 3.	3 days	No
Secondary	Opiod Sparing	Total amount of rescue medication requires	3 days	Yes
Secondary	Side effect of medication	Severity of Post operative nausea and vomiting (PONV) graded with mild, moderare and severe(Vomiting) Side effect of medication includes headache, giddiness, visual disturbance, and difficulty in walking.	3 days	Yes