Back to resultsEffect Nitrous Oxide On Acute Postoperative Pain and Opioid Consumption and Chronic Pain After Inguinal Hernia Repair Surgery
Primary Purpose
Inguinal Hernia Repair, Post Operative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Nitrous Oxide
oxygen
Sponsored by
About this trial
This is an interventional supportive care trial for Inguinal Hernia Repair
Eligibility Criteria
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).
Sites / Locations
- Gulhane Military Medical Academy HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nitrous oxide
Oxygen
Arm Description
Subjects will receive General anesthesia with Nitrous Oxide.
Subjects will receive General anesthesia with oxygen.
Outcomes
Primary Outcome Measures
Nitrous oxide and chronic pain
The effect of 70% N20/30% O2 on post inguinal hernia repair procedure in prevention of chronic pain.
Nitrous oxide and opioid consumption
The effect of 70% N20/30% O2 on post inguinal hernia repair procedure in decrease in opioid consumption.
Secondary Outcome Measures
smoking and post operative pain
The effect of active smoking to increase post operative acute pain.
smoking and chronic pain
The effect of active smoking and chronic pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01622322
Brief Title
Effect Nitrous Oxide On Acute Postoperative Pain and Opioid Consumption and Chronic Pain After Inguinal Hernia Repair Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia Repair, Post Operative Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nitrous oxide
Arm Type
Experimental
Arm Description
Subjects will receive General anesthesia with Nitrous Oxide.
Arm Title
Oxygen
Arm Type
Placebo Comparator
Arm Description
Subjects will receive General anesthesia with oxygen.
Intervention Type
Drug
Intervention Name(s)
Nitrous Oxide
Intervention Description
Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
Intervention Type
Other
Intervention Name(s)
oxygen
Intervention Description
Subjects will receive General anesthesia: (Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
Primary Outcome Measure Information:
Title
Nitrous oxide and chronic pain
Description
The effect of 70% N20/30% O2 on post inguinal hernia repair procedure in prevention of chronic pain.
Time Frame
30 days post operative
Title
Nitrous oxide and opioid consumption
Description
The effect of 70% N20/30% O2 on post inguinal hernia repair procedure in decrease in opioid consumption.
Time Frame
4 hours after surgery
Secondary Outcome Measure Information:
Title
smoking and post operative pain
Description
The effect of active smoking to increase post operative acute pain.
Time Frame
4 hours after surgery
Title
smoking and chronic pain
Description
The effect of active smoking and chronic pain
Time Frame
30 days post operative
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:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdulkadir Atim, M.D.
Phone
+90 312 304 5911
Email
drkadiratim@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alparslan Turan, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulhane Military Medical Academy Hospital
City
Etlik
State/Province
Ankara
ZIP/Postal Code
06018
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdulkadir Atim, M.D.
Phone
+90 312 304 5911
Email
drkadiratim@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Effect Nitrous Oxide On Acute Postoperative Pain and Opioid Consumption and Chronic Pain After Inguinal Hernia Repair Surgery
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