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

Primary Purpose

Inguinal Hernia, Postoperative Pain

Status
Unknown status
Phase
Phase 3
Locations
Malaysia
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inguinal Hernia focused on measuring Clinical diagnosis of inguinal hernia, Patient undergo operation under daycare basis, ASA I-II, Written consent

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University MalayaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pregabalin Group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Opiod Sparing
Total amount of rescue medication requires
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.

Full Information

First Posted
September 24, 2011
Last Updated
October 11, 2011
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT01450345
Brief Title
Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain
Official Title
Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Postoperative Pain
Keywords
Clinical diagnosis of inguinal hernia, Patient undergo operation under daycare basis, ASA I-II, Written consent

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin Group
Arm Type
Experimental
Arm Description
The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica 150mg
Intervention Description
The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Opiod Sparing
Description
Total amount of rescue medication requires
Time Frame
3 days
Title
Side effect of medication
Description
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.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CharngChee Toh, MBBS, MRCS
Phone
60193380337
Email
toh2c79@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CharngChee Toh, MBBS, MRCS
Organizational Affiliation
University Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Malaya
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CharngChee Toh, MBBS, MRCS
Phone
60193380337
Email
toh2c79@yahoo.com
First Name & Middle Initial & Last Name & Degree
CharngChee Toh, MBBS, MRCS

12. IPD Sharing Statement

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

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