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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02884986
Enrollment
60
Registered
2016-08-31
Start date
2015-01-31
Completion date
2016-01-31
Last updated
2016-08-31

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

Conditions

Adverse Anesthesia Outcome

Keywords

Etoricoxib, Spinal anaesthesia, Postoperative pain

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.

Interventions

DRUGEtoricoxib

120mg of oral etoricoxib under the brand name Arcoxia® (Merck Sharp & Dohme) one hour prior to spinal anaesthesia induction

DRUGPlacebo

120mg of placebo

Sponsors

Bnai Zion Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain VAS ScoreEach four hours until 24 hoursIn the post operative period

Countries

Israel

Outcome results

None listed

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