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

• Sponsor: Bnai Zion Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02884986
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Adverse Anesthesia Outcome	Drug: Etoricoxib; Drug: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomised Controlled Trial - Multimodal Analgesia in Inguinal Hernia Repair Using a Cyclooxygenase-2-specific Inhibitor: A Randomised Controlled Trial
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Etoricoxib 120mg of oral Etoricoxib under the brand name Arcoxia® (Merck Sharp & Dohme) one hour prior to spinal anaesthesia induction	Drug: Etoricoxib; 120mg of oral etoricoxib under the brand name Arcoxia® (Merck Sharp & Dohme) one hour prior to spinal anaesthesia induction
Placebo Comparator: Placebo 120mg of oral Placebo the same amount as the drug administrated one hour prior to spinal anaesthesia induction	Drug: Placebo; 120mg of placebo

Outcome Measures

Primary Outcome Measures

1. Pain VAS Score [Each four hours until 24 hours]

   In the post operative period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bnai Zion Medical Center	Haifa		Israel

Sponsors and Collaborators

• Bnai Zion Medical Center

Investigators

• Principal Investigator: Luis A Gaitini, M.D., Bnai Zion Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LUIS.GAITINI, M.D., Bnai Zion Medical Center
• ClinicalTrials.gov Identifier: NCT02884986
• Other Study ID Numbers: BnaiZionMC-16-LG-009
• First Posted: Aug 31, 2016
• Last Update Posted: Aug 31, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by LUIS.GAITINI, M.D., Bnai Zion Medical Center: Etoricoxib; Spinal anaesthesia; Postoperative pain
• Additional relevant MeSH terms: Hernia, Inguinal; Etoricoxib

Study Results

No Results Posted as of Aug 31, 2016