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

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01622322
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 127
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Inguinal Hernia Repair; Post Operative Pain	Drug: Nitrous Oxide; Other: oxygen	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Study Start Date: May 1, 2012
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nitrous oxide Subjects will receive General anesthesia with Nitrous Oxide.	Drug: Nitrous Oxide; Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
Placebo Comparator: Oxygen Subjects will receive General anesthesia with oxygen.	Other: oxygen; Subjects will receive General anesthesia: (Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Secondary Outcome Measures

1. smoking and post operative pain [4 hours after surgery]

   The effect of active smoking to increase post operative acute pain.

2. smoking and chronic pain [30 days post operative]

   The effect of active smoking and chronic pain

Eligibility Criteria

Criteria

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

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gulhane Military Medical Academy Hospital	Etlik	Ankara	Turkey	06018

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Alparslan Turan, M.D., The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alparslan Turan, PI, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT01622322
• Other Study ID Numbers: 10/1539
• First Posted: Jun 19, 2012
• Last Update Posted: Oct 18, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Hernia; Pain, Postoperative; Hernia, Inguinal; Nitrous Oxide

Study Results

No Results Posted as of Oct 18, 2021