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Completed

NCT Number: NCT02884986

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bnai Zion Medical Center

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etoricoxib

Drug

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

Placebo

Drug

120mg of placebo

Primary outcomes

  1. Pain VAS Score

    Time frame: Each four hours until 24 hours

    In the post operative period

Sponsors and collaborators

Lead sponsor

Bnai Zion Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Aug 31, 2016
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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