MedPath

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

Not Applicable
Completed
Conditions
Adverse Anesthesia Outcome
Interventions
Drug: Placebo
Registration Number
NCT02884986
Lead Sponsor
Bnai Zion Medical Center
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo120mg of oral Placebo the same amount as the drug administrated one hour prior to spinal anaesthesia induction
EtoricoxibEtoricoxib120mg of oral Etoricoxib under the brand name Arcoxia® (Merck Sharp \& Dohme) one hour prior to spinal anaesthesia induction
Primary Outcome Measures
NameTimeMethod
Pain VAS ScoreEach four hours until 24 hours

In the post operative period

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Bnai Zion Medical Center

🇮🇱

Haifa, Israel

© Copyright 2025. All Rights Reserved by MedPath