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

November 13, 2023 updated by: Alparslan Turan, The Cleveland Clinic

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ankara
      • Etlik, Ankara, Turkey, 06018
        • Gulhane Military Medical Academy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nitrous oxide and chronic pain
Time Frame: 30 days post operative
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
Time Frame: 4 hours after surgery
The effect of 70% N20/30% O2 on post inguinal hernia repair procedure in decrease in opioid consumption.
4 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
smoking and post operative pain
Time Frame: 4 hours after surgery
The effect of active smoking to increase post operative acute pain.
4 hours after surgery
smoking and chronic pain
Time Frame: 30 days post operative
The effect of active smoking and chronic pain
30 days post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimated)

June 19, 2012

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/1539

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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