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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Inguinal Hernia Repair Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Nitrous oxide

Subjects will receive General anesthesia with Nitrous Oxide.

Group Type EXPERIMENTAL

Nitrous Oxide

Intervention Type DRUG

Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.

Oxygen

Subjects will receive General anesthesia with oxygen.

Group Type PLACEBO_COMPARATOR

oxygen

Intervention Type OTHER

Subjects will receive General anesthesia: (Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.

Interventions

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Nitrous Oxide

Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.

Intervention Type DRUG

oxygen

Subjects will receive General anesthesia: (Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No