Analgesia in Inguinal Hernia Repair Using a Cyclooxygenase-2-specific Inhibitor

Study Overview
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Brief Summary
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Acute pain is the result of activating nociceptive pathways in both the peripheral and central nervous system. The origin of most acute pain from surgical stimulation is the mechanical trauma of the local tissue and the subsequent acute inflammatory response. No studies have investigated the combined use of anti-inflammatory analgesics with spinal anaesthesia/analgesia for pre, intra and postoperative multimodal pain protection in patients undergoing day-case IHR. The aim of the investigators study is therefore to assess the efficacy of preoperative combined administration of etoricoxib and standard spinal anaesthesia in the reduction of postoperative pain following IHR.

Detailed Description
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Acute pain is the result of activating nociceptive pathways in both the peripheral and central nervous system. The origin of most acute pain from surgical stimulation is the mechanical trauma of the local tissue and the subsequent acute inflammatory response. Open inguinal hernia repair is one of the commonest surgical procedures which may provoke pain of variable intensity and duration. Etoricoxib (Arcoxia®) is a NSAID with anti-inflammatory and analgesic properties mainly achieved via selective peripheral COX-2 inhibition. Spinal anaesthesia using local anaesthetics combined with opioids affects the transmission, modulation and modification stages of nociceptive afferent impulses and its analgesic qualities are superior to local anaesthesia alone. No studies have investigated the combined use of anti-inflammatory analgesics with spinal anaesthesia/analgesia for pre, intra and postoperative multimodal pain protection in patients undergoing day-case IHR. The aim of the investigators study is therefore to assess the efficacy of preoperative combined administration of etoricoxib and standard spinal anaesthesia in the reduction of postoperative pain following IHR.

Official Title
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Randomised Controlled Trial - Multimodal Analgesia in Inguinal Hernia Repair Using a Cyclooxygenase-2-specific Inhibitor: A Randomised Controlled Trial

Conditions
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Adverse Anesthesia Outcome

Intervention / Treatment
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* Drug: Etoricoxib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society Anesthesiology Class I and II Exclusion Criteria: Under treatment with Non Steroid Antinflammatory Drug Under Opioid treatment Peptic ulcer Liver insufficiency Renal insufficiency Asthma Cardiovascular disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Etoricoxib<br>120mg of oral Etoricoxib under the brand name Arcoxia® (Merck Sharp & Dohme) one hour prior to spinal anaesthesia induction | Drug: Etoricoxib<br>* 120mg of oral etoricoxib under the brand name Arcoxia® (Merck Sharp & Dohme) one hour prior to spinal anaesthesia induction<br>|
| Placebo Comparator: Placebo<br>120mg of oral Placebo the same amount as the drug administrated one hour prior to spinal anaesthesia induction | Drug: Placebo<br>* 120mg of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain VAS Score | In the post operative period | Each four hours until 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Etoricoxib, Spinal anaesthesia, Postoperative pain