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

Primary Purpose

Adverse Anesthesia Outcome

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Etoricoxib
Placebo
Sponsored by
Bnai Zion Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adverse Anesthesia Outcome focused on measuring Etoricoxib, Spinal anaesthesia, Postoperative pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bnai Zion Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Etoricoxib

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain VAS Score
In the post operative period

Secondary Outcome Measures

Full Information

First Posted
August 17, 2016
Last Updated
August 30, 2016
Sponsor
Bnai Zion Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02884986
Brief Title
Analgesia in Inguinal Hernia Repair Using a Cyclooxygenase-2-specific Inhibitor
Official Title
Randomised Controlled Trial - Multimodal Analgesia in Inguinal Hernia Repair Using a Cyclooxygenase-2-specific Inhibitor: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bnai Zion Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Anesthesia Outcome
Keywords
Etoricoxib, Spinal anaesthesia, Postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etoricoxib
Arm Type
Active Comparator
Arm Description
120mg of oral Etoricoxib under the brand name Arcoxia® (Merck Sharp & Dohme) one hour prior to spinal anaesthesia induction
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
120mg of oral Placebo the same amount as the drug administrated one hour prior to spinal anaesthesia induction
Intervention Type
Drug
Intervention Name(s)
Etoricoxib
Intervention Description
120mg of oral etoricoxib under the brand name Arcoxia® (Merck Sharp & Dohme) one hour prior to spinal anaesthesia induction
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
120mg of placebo
Primary Outcome Measure Information:
Title
Pain VAS Score
Description
In the post operative period
Time Frame
Each four hours until 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis A Gaitini, M.D.
Organizational Affiliation
Bnai Zion Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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