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

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01622335
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 133
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Hysterectomy (& Wertheim); Nitrous Oxide; General Anesthesia	Drug: Nitrous oxide; Other: General anesthesia with oxygen	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic
• Study Start Date: May 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: General anesthesia with oxygen General anesthesia and Air	Other: General anesthesia with oxygen; 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	Drug: Nitrous oxide; General anesthesia with Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.

Outcome Measures

Primary Outcome Measures

1. Nitrous oxide and chronic pain [30 days post operative]

   The of the effect of 50% N20/50% O2 on post hysterectomy in prevention of chronic pain.

2. Nitrous oxide and opioid consumption [4 hours post operative]

   The effect of 50% N20/50% O2 on post hysterectomy in decrease of opioid consumption.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gulhane Military Medical Academy Hospital	Etlik	Ankara	Turkey	06018

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alparslan Turan, Principal Investigatgor, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT01622335
• Other Study ID Numbers: 1491-952
• First Posted: Jun 19, 2012
• Last Update Posted: Jan 12, 2022
• Last Verified: Jan 1, 2022

• Additional relevant MeSH terms: Acute Pain; Nitrous Oxide

Study Results

No Results Posted as of Jan 12, 2022