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

Bnai Zion Medical Center

Status: Completed

Conditions: Adverse Anesthesia Outcome

Treatments: Drug: Etoricoxib; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02884986

BnaiZionMC-16-LG-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Etoricoxib

Active Comparator group

Description:

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

Treatment:

Drug: Etoricoxib

Placebo

Placebo Comparator group

Description:

120mg of oral Placebo the same amount as the drug administrated one hour prior to spinal anaesthesia induction

Treatment:

Drug: Placebo