NCT02884986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

Same day

First QC Date

August 17, 2016

Last Update Submit

August 30, 2016

Conditions

Adverse Anesthesia Outcome

Keywords

EtoricoxibSpinal anaesthesiaPostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Pain VAS Score

    In the post operative period

    Each four hours until 24 hours

Study Arms (2)

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

EtoricoxibDRUG

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

Etoricoxib
PlaceboDRUG

120mg of placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society Anesthesiology Class I and II

You may not qualify if:

  • Under treatment with Non Steroid Antinflammatory Drug
  • Under Opioid treatment
  • Peptic ulcer
  • Liver insufficiency
  • Renal insufficiency
  • Asthma
  • Cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Luis A Gaitini, M.D.

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 31, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

August 31, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

IL(1)