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

NCT ID: NCT02884986

Last Updated: 2016-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-01-31

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.

Conditions

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Adverse Anesthesia Outcome

Keywords

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Etoricoxib Spinal anaesthesia Postoperative pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Etoricoxib

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

Group Type ACTIVE_COMPARATOR

Etoricoxib

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

120mg of placebo

Interventions

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Etoricoxib

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

Intervention Type DRUG

Placebo

120mg of placebo

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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LUIS.GAITINI

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luis A Gaitini, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion Medical Center

Locations

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Bnai Zion Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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BnaiZionMC-16-LG-009

Identifier Type: -

Identifier Source: org_study_id