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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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).

Related Conditions & MeSH terms

• Chronic Pain
• Hernia
• Hernia, Inguinal
• Inguinal Hernia Repair
• Pain, Postoperative
• Post Operative Pain

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