- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01622335
Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic Pain After Hysterectomy
July 8, 2023 updated by: Alparslan Turan, The Cleveland Clinic
Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic
The study is prospective and double blind.
In the clinic, patients undergoing hysterectomy that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
The study is prospective and double blind.
In the clinic, patients undergoing hysterectomy 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
Enrollment (Estimated)
200
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 Contact
- Name: Abdulkadir Atim, M.D.
- Phone Number: +90 312 304 5911
- Email: drkadiratim@yahoo.com
Study Locations
-
-
Ankara
-
Etlik, Ankara, Turkey, 06018
- Recruiting
- Gulhane Military Medical Academy Hospital
-
Contact:
- Abdulkadir Atim, M.D.
- Phone Number: +90 312 304 5911
- Email: drkadiratim@yahoo.com
-
-
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
- Female
- American Society of Anesthesiologists physical status I or II
- Hysterectomy 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 |
---|---|
Placebo Comparator: General anesthesia with oxygen
General anesthesia and Air
|
General anesthesia with(Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
|
Experimental: nitrous oxide and general anesthesia
General anesthesia with Nitrous Oxide
|
General anesthesia with Nitrous Oxide, 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 of the effect of 50% N20/50% O2 on post hysterectomy in prevention of chronic pain.
|
30 days post operative
|
Nitrous oxide and opioid consumption
Time Frame: 4 hours post operative
|
The effect of 50% N20/50% O2 on post hysterectomy in decrease of opioid consumption.
|
4 hours post operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
December 1, 2022
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)
July 11, 2023
Last Update Submitted That Met QC Criteria
July 8, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1491-952
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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