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NCT01622322 Clinical Trial

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

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01622322
Other study ID # 10/1539
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date May 2012
Est. completion date December 2023

Study information
Verified date November 2023
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Nitrous Oxide
Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
Other:
• oxygen
Subjects will receive General anesthesia: (Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.

Locations
Country Name City State
Turkey Gulhane Military Medical Academy Hospital Etlik Ankara

Sponsors (1)
Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 smoking and post operative pain The effect of active smoking to increase post operative acute pain. 4 hours after surgery
Secondary smoking and chronic pain The effect of active smoking and chronic pain 30 days post operative
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