Study Stopped
no enrollment
Nitrous Oxide On Acute Postoperative Pain and Opioid Consumption and Chronic Pain After Inguinal Hernia Repair Surgery
Effect Nitrous Oxide On Acute Postoperative Pain and Opioid Consumption and Chronic Pain After Inguinal Hernia Repair Surgery
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 15, 2012
CompletedFirst Posted
Study publicly available on registry
June 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedNovember 15, 2023
November 1, 2023
11.6 years
June 15, 2012
November 13, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Nitrous oxide and chronic pain
The effect of 70% N20/30% O2 on post inguinal hernia repair procedure in prevention of chronic pain.
30 days post operative
Nitrous oxide and opioid consumption
The effect of 70% N20/30% O2 on post inguinal hernia repair procedure in decrease in opioid consumption.
4 hours after surgery
Secondary Outcomes (2)
smoking and post operative pain
4 hours after surgery
smoking and chronic pain
30 days post operative
Study Arms (2)
Nitrous oxide
EXPERIMENTALSubjects will receive General anesthesia with Nitrous Oxide.
Oxygen
PLACEBO COMPARATORSubjects will receive General anesthesia with oxygen.
Interventions
Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
Subjects will receive General anesthesia: (Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gulhane Military Medical Academy Hospital
Etlik, Ankara, 06018, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alparslan Turan, M.D.
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
June 15, 2012
First Posted
June 19, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
November 15, 2023
Record last verified: 2023-11