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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University of Malaya.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Toh Charng Chee, University of Malaya
ClinicalTrials.gov Identifier:
NCT01450345
First received: September 24, 2011
Last updated: October 11, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Inguinal Hernia
Postoperative Pain
Drug: Pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain

Resource links provided by NLM:


Further study details as provided by University of Malaya:

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. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Total amount of rescue medication requires

  • Side effect of medication [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 72
Study Start Date: September 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin Group
The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.
Drug: Pregabalin
The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.
Other Name: Lyrica 150mg

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450345

Contacts
Contact: CharngChee Toh, MBBS, MRCS 60193380337 toh2c79@yahoo.com

Locations
Malaysia
University Malaya Recruiting
Kuala Lumpur, Malaysia, 59100
Contact: CharngChee Toh, MBBS, MRCS    60193380337    toh2c79@yahoo.com   
Principal Investigator: CharngChee Toh, MBBS, MRCS         
Sponsors and Collaborators
University of Malaya
Investigators
Principal Investigator: CharngChee Toh, MBBS, MRCS University Malaya
  More Information

No publications provided

Responsible Party: Toh Charng Chee, Principle Investigator, University of Malaya
ClinicalTrials.gov Identifier: NCT01450345     History of Changes
Other Study ID Numbers: toh2c79@Pregabalin
Study First Received: September 24, 2011
Last Updated: October 11, 2011
Health Authority: Malaysia: Ministry of Health

Keywords provided by University of Malaya:
Clinical diagnosis of inguinal hernia
Patient undergo operation under daycare basis
ASA I-II
Written consent

Additional relevant MeSH terms:
Hernia, Inguinal
Hernia
Pain, Postoperative
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Hernia, Abdominal
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 22, 2014