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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01450345
Enrollment
72
Registered
2011-10-12
Start date
2009-09-30
Completion date
2011-12-31
Last updated
2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia, Postoperative Pain

Keywords

Clinical diagnosis of inguinal hernia, Patient undergo operation under daycare basis, ASA I-II, Written consent

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.

Interventions

DRUGPregabalin

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

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 3.3 daysEfficacy: 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

MeasureTime frameDescription
Opiod Sparing3 daysTotal amount of rescue medication requires
Side effect of medication3 daysSeverity 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.

Countries

Malaysia

Contacts

Primary ContactCharngChee Toh, MBBS, MRCS
toh2c79@yahoo.com60193380337

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026