Nitrous Oxide On Acute Postoperative Pain and Opioid Consumption and Chronic Pain After Inguinal Hernia Repair Surgery

Not Applicable

Withdrawn

• Conditions: Inguinal Hernia Repair; Post Operative Pain
• Interventions: Drug: Nitrous Oxide; Other: oxygen

• Registration Number: NCT01622322
• Lead Sponsor: The Cleveland Clinic

Brief Summary

To compare postoperative pain, opioid consumption and chronic pain in patients undergoing to hernia repair surgery after receiving nitrous oxide or oxygen during the general anesthesia.

Detailed Description

The study is prospective and double blind. In the clinic, patients undergoing inguinal hernia surgery that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups. In the first group of patients will receive Nitrous Oxide and In the second group of patients will receive oxygen during the general anesthesia.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-15
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-19
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 18 to 65 years old at time of the first procedure
• American Society of Anesthesiologists physical status I or II
• Inguinal hernia repair surgery undergoing the general anesthesia

Exclusion Criteria

• Neuropathic disease
• Chronic opioid users
• Contraindication for Nitrous Oxide receive
• Consent will not be obtained patient
• Psychiatric disorders
• Current or recent drug abuse (within past 6 months).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitrous oxide	Nitrous Oxide	Subjects will receive General anesthesia with Nitrous Oxide.
Oxygen	oxygen	Subjects will receive General anesthesia with oxygen.

Primary Outcome Measures

Name	Time	Method
Nitrous oxide and opioid consumption	4 hours after surgery	The effect of 70% N20/30% O2 on post inguinal hernia repair procedure in decrease in opioid consumption.
Nitrous oxide and chronic pain	30 days post operative	The effect of 70% N20/30% O2 on post inguinal hernia repair procedure in prevention of chronic pain.

Secondary Outcome Measures

Name	Time	Method
smoking and chronic pain	30 days post operative	The effect of active smoking and chronic pain
smoking and post operative pain	4 hours after surgery	The effect of active smoking to increase post operative acute pain.

Trial Locations

Locations (1)

Gulhane Military Medical Academy Hospital; 🇹🇷 Etlik, Ankara, Turkey