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Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic Pain After Hysterectomy

Primary Purpose

Abdominal Hysterectomy (& Wertheim), Nitrous Oxide, General Anesthesia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Nitrous oxide
General anesthesia with oxygen
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Abdominal Hysterectomy (& Wertheim)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Gulhane Military Medical Academy HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

General anesthesia with oxygen

nitrous oxide and general anesthesia

Arm Description

General anesthesia and Air

General anesthesia with Nitrous Oxide

Outcomes

Primary Outcome Measures

Nitrous oxide and chronic pain
The of the effect of 50% N20/50% O2 on post hysterectomy in prevention of chronic pain.
Nitrous oxide and opioid consumption
The effect of 50% N20/50% O2 on post hysterectomy in decrease of opioid consumption.

Secondary Outcome Measures

Full Information

First Posted
June 15, 2012
Last Updated
July 8, 2023
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01622335
Brief Title
Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic Pain After Hysterectomy
Official Title
Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Hysterectomy (& Wertheim), Nitrous Oxide, General Anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General anesthesia with oxygen
Arm Type
Placebo Comparator
Arm Description
General anesthesia and Air
Arm Title
nitrous oxide and general anesthesia
Arm Type
Experimental
Arm Description
General anesthesia with Nitrous Oxide
Intervention Type
Drug
Intervention Name(s)
Nitrous oxide
Intervention Description
General anesthesia with Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
Intervention Type
Other
Intervention Name(s)
General anesthesia with oxygen
Intervention Description
General anesthesia with(Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
Primary Outcome Measure Information:
Title
Nitrous oxide and chronic pain
Description
The of the effect of 50% N20/50% O2 on post hysterectomy in prevention of chronic pain.
Time Frame
30 days post operative
Title
Nitrous oxide and opioid consumption
Description
The effect of 50% N20/50% O2 on post hysterectomy in decrease of opioid consumption.
Time Frame
4 hours post operative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdulkadir Atim, M.D.
Phone
+90 312 304 5911
Email
drkadiratim@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alparslan Turan, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulhane Military Medical Academy Hospital
City
Etlik
State/Province
Ankara
ZIP/Postal Code
06018
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdulkadir Atim, M.D.
Phone
+90 312 304 5911
Email
drkadiratim@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic Pain After Hysterectomy

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