Analgesia in Inguinal Hernia Repair Using a Cyclooxygenas... | NCT02884986

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

NCT02884986

Sponsor

Bnai Zion Medical Center

Status

Completed

Last Update Posted

Aug 31, 2016Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Adverse Anesthesia Outcome

Interventions

Etoricoxib
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

Aug 17, 2016

First Submission Date that Met QC Criteria

Aug 30, 2016

First Posted Date

Aug 31, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2016

Last Update Posted Date

Aug 31, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

LUIS.GAITINI, M.D., Bnai Zion Medical CenterPrincipal Investigator

Lead Sponsor

Bnai Zion Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Etoricoxib	Active Comparator	120mg of oral Etoricoxib under the brand name Arcoxia® (Merck Sharp & Dohme) one hour prior to spinal anaesthesia induction	Drug: Etoricoxib
Placebo	Placebo Comparator	120mg of oral Placebo the same amount as the drug administrated one hour prior to spinal anaesthesia induction	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Etoricoxib	Drug	120mg of oral etoricoxib under the brand name Arcoxia® (Merck Sharp & Dohme) one hour prior to spinal anaesthesia induction	Etoricoxib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain VAS Score	In the post operative period	Each four hours until 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luis A Gaitini, M.D.	Bnai Zion Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bnai Zion Medical Center		Haifa			Israel

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077613	Etoricoxib

Ancestor Terms

ID	Term
D013450	Sulfones
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines

Browse Leaves

Not provided

Browse Branches

Not provided