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

Not Applicable

Withdrawn

• Conditions: Abdominal Hysterectomy (& Wertheim); Nitrous Oxide; General Anesthesia
• Interventions: Other: General anesthesia with oxygen; Drug: Nitrous oxide

• Registration Number: NCT01622335
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-15
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-19
• Primary Completion: 2022-12
• Study Completion: 2023-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia with oxygen	General anesthesia with oxygen	General anesthesia and Air
nitrous oxide and general anesthesia	Nitrous oxide	General anesthesia with Nitrous Oxide

Primary Outcome Measures

Name	Time	Method
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.
Nitrous oxide and opioid consumption	4 hours post operative	The effect of 50% N20/50% O2 on post hysterectomy in decrease of opioid consumption.

Trial Locations

Locations (1)

Gulhane Military Medical Academy Hospital; 🇹🇷 Etlik, Ankara, Turkey